north london cancer research network · nlcrn annual report 2012/2013 north london cancer research...

North London Cancer Research

NLCRN ANNUA

Network

Dr Masuma Harrison

Research NetworkManager

28/06/2013

Aderonke Adebiyi

Research NetworkManager

28/06/2013

Annual Report 2012-2013

L REPORT 2012/2013

Dr James Lyddiard

Senior Research NetworkManager

28/06/2013

Dr John Bridgewater

Clinical Lead

28/06/2013

NLCRN ANNUAL REPORT 2012/2013

CONTENTS

List of Abbreviations....................................................................................................... 4

Acknowledgements......................................................................................................... 5

Executive Summary ........................................................................................................ 6

Table 1: Research Profile in North London....................................................................... 7

Section 1: Organisation and Development of the Network .............................................. 9Figure 1: North London Cancer Research Network Structure Chart ........................................................ 11

Challenges.................................................................................................................. 12

Children’s Cancer and Leukaemia Community ....................................................... 12

Interaction with Cancer Service Network .................................................................... 13

Peer Review................................................................................................................ 14

Interaction with Other Research Infrastructure........................................................... 15

Financial Statement....................................................................................................... 16

Section 2: Portfolio and Recruitment Overview 2011-12................................................ 17Table 2: Total Annual Recruitment 2001-13........................................................................................... 177

Figure 2: Total Annual Recruitment 2001-13 ........................................................................................... 18

Clinical Studies Group (CSG) Performance 2012-13 ............................................... 19Figure 3: Local Research Network Overall Yearly Recruitment by CSG (Improved CSG 2012-13)......... 19

Performance against forecast recruitment 2012-13................................................. 21Table 3: Summary of Forecast Activity..................................................................................................... 21

Delivery of NIHR CRN adopted commercial studies 2012-13.................................. 22

Balance of Portfolio ................................................................................................... 23Table 4: Table of trust and network portfolio, recruitment of participants benchmarked to national

performance 2012-13............................................................................................................................. 233

Trust Performance 2011-12 ....................................................................................... 29Figure 4: Annual Participant Recruitment by Trust ( 2010-11, 2011-12, 2012-13) ................................... 29

Barnet & Chase Farm Hospitals NHS Trust (BCFH) ................................................ 30Figure 5A: Summary of Portfolio Activity & Key Achievements 2012-13.................................................. 30

Table 5A: Patient Referral from BCFH to other NLCRN trusts 2012-13................................................... 31

Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH).......... 32Figure 5B: Summary of Portfolio Activity & Key Achievements 2012-13.................................................. 32

Table 5B: Patient Referral from GOSH to other NLCRN trusts 2012-13.................................................. 33

North Middlesex University Hospital NHS Trust (NMH) .......................................... 34Figure 5C: Summary of Portfolio Activity & Key Achievements 2012-13 ................................................. 34

Table 5C: Patient Referral from NMH to other NLCRN trusts 2012-13 .................................................... 35

The Princess Alexandra Hospital NHS Trust (PAH)................................................. 36Figure 5D: Summary of Portfolio Activity & Key Achievements 2012-13 ................................................. 36

Table 5D: Patient Referral from PAH to other NLCRN trusts 2012-13..................................................... 37

Royal Free London NHS Foundation Trust (RFH).................................................... 38Figure 5E: Summary of Portfolio Activity & Key Achievements 2012-13.................................................. 38

Table 5E: Patient Referral from RFH to other NLCRN trust 2012-13....................................................... 39

University College London Hospitals NHS Foundation Trust (UCLH) ................... 40Figure 5F: Summary of Portfolio Activity & Key Achievements 2012-13.................................................. 40

Table 5F: Patient Referral from UCLH to other NLCRN trusts 2012-13................................................... 41

The Whittington Hospital NHS Trust (WH) ............................................................... 42Figure 5G: Summary of Portfolio Activity & Key Achievements 2012-13 ................................................. 42

Table 5G: Patient Referral from WH to other NLCRN trusts 2012-13 ...................................................... 43

Follow up.................................................................................................................... 44

Non-portfolio activity................................................................................................. 44


Section 3: Workforce ...................................................................................................... 455

Infrastructure ............................................................................................................. 45Figure 6: Centralised NLCRN Team Organogram ................................................................................... 46

Table 6: Whole Time Equivalents across the Whole Research Network ................................................. 47

Workforce Development............................................................................................ 48

Additional Local Initiatives........................................................................................ 49

Section 4: Patient and Public Involvement (PPI) ............................................................ 50

Social Media and PPI: The NLCRN Twitter Feed...................................................... 52

Section 5: Other Initiatives ............................................................................................... 53

Future Plans................................................................................................................... 54

Appendices.................................................................................................................... 56

Appendix 1: NLCRN Portfolio Activity...................................................................... 56Table 7: Portfolio and recruitment for 2012-13 (compared against forecast recruitment) ........................ 56

Appendix 2: Delivery of NIHR Clinical Research Network adopted Commercial

Studies........................................................................................................................ 67Table 8A: Studies which closed to recruitment nationally during the 2012-13 reporting year .................. 67

Table 8B: Remaining studies open to recruitment nationally during the 2012-13 reporting year ............. 69

Appendix 3: Follow-up............................................................................................... 73Table 9: Patients follow-up numbers........................................................................................................ 73

Appendix 4: Executive Summary of Workforce Development Annual Report for

London & SE England ............................................................................................... 75


List of Abbreviations

ASCO American Society of Clinical OncologyBCFH Barnet and Chase Farm Hospitals NHS TrustCCLG Children’s Cancer and Leukaemia GroupCCRN Comprehensive Clinical Research NetworkCEL CLRN Central and East London Comprehensive Local Research NetworkCR UK Cancer Research UKCRF Clinical Research FacilityCRN Cancer Research NetworkCSG Clinical Studies GroupCSP Coordinated System for Gaining NHS PermissionCTA Clinical Trials AgreementCTP Clinical Trials PractitionerCTU Clinical Trials UnitGCP Good Clinical PracticeGOSH Great Ormond Street Hospital for Children NHS Foundation TrustHR Human ResourcesICS Integrated Cancer SystemIRAS Integrated Research Application SystemIM Industry ManagerLCRN Local Clinical Research NetworkNCRI National Cancer Research InstituteNCRN National Cancer Research NetworkNELCRN North East London Cancer Research NetworkNIHR National Institute for Health ResearchNLCRN North London Cancer Research NetworkNMH North Middlesex University Hospital NHS TrustNSSG Network Site Specific GroupPAH The Princess Alexandra Hospital NHS TrustPI Principal InvestigatorPIC Patient Identifier CentrePOSCUs Paediatric Oncology Shared Care UnitsPPI Patient and Public InvolvementPTCs Principal Treatment CentresQA Quality AssuranceR&D Research and DevelopmentRCF Research Capability FundingRCT Randomised Controlled TrialRFH Royal Free London NHS Foundation TrustRNM Research Network ManagerSOP Standard Operating ProceduresSSI Site Specific InformationT&E Training and EducationUCL University College LondonUCL ECMC UCL Experimental Cancer Medicine CentreUCLH University College London Hospitals NHS Foundation TrustUCLP University College London PartnersWH The Whittington Hospital NHS TrustWTE Whole Time Equivalent


Acknowledgements

We would like to thank everyone who has contributed to the annual report, all the research

staff and clinicians that work across North London and all the patients that have taken part in

trials. It has been another successful year made possible by everyone’s contribution. Thanks

also to Guilherme Schroeter (Guy), our QA Manager, for all his hard-work and efforts to get

this report completed on time.

James, Ade and Guy


Executive Summary

The North London cancer research Network is one of 32 Cancer research networks which

covers the whole of the NHS in England. The NLCRN is hosted by University College

Hospital Foundation trust and serves a population of 1.65 million. In 2012/13 the NLCRN

supported a portfolio of 172 studies.

The year of 2012-13 has been a challenging year for the NLCRN. The Network, the North

East London Cancer Network (NELCRN) and the Central and East London Comprehensive

Local Research Network (CEL CLRN) have been working together in preparation for the pilot

commencing in April 2013. We hope that this collaboration will help to inform the transition

due to start in April 2014.

CEL CLRN provided additional funding to the NLCRN to provide service support cost

funding for new cancer studies this year. This funding in addition to CEL CLRN contingency

for a number of key posts has augmented the trials support provided by the core budget of

£600,312 with RCF of £119,170. The NLCRN core budget and RCF together supported

18.84 WTE, additionally CLRN funding and other sources contributed to a total workforce of

118.8 WTE.

Trial recruitment has increased in 2012/13 we were successful in recruiting 2118 patients

demonstrating a year on year increase this represents an almost 16% increase in overall

recruitment compared with 2011/12 we have done particularly well in non-RCT’S this year

where we have seen almost 24% increase in recruitment despite changes and variability on

the NCRN portfolios.

Portfolio’s that performed extremely well with significant increases in activity in 2012/13 were

breast, upper-GI, prostate and CCLG. Areas that require development are the lung and

melanoma portfolios. Activity has been varied across the sites with marked increase at

UCLH, PAH and GOSH whilst NMH, BH and RFH have seen a decrease in activity. This has

been due in part to staff turnover and the closure of key trials. WH recruitment has remained

stable. The year has seen almost a doubling in the number of commercial trials that closed

to recruitment, 15 trials closed this year compared to only 8 last year. The number of open

trials has increased, being 47 as compared with 27 in the previous year. The Harmonisation

project, which set tight timelines on approval of these projects started in October 2012 and

has had mixed success; however, the project is still in its early stages.

The centralised team are crucial to the success of the wider network, both operationally and

strategically and continue to provide direct contact and support for study set-up, quality

assurance, industry trials and workforce development.

Overall the NLCRN remains a strong, well organised and effective organisation in delivering

clinical trials recruitment. We would hope this is maintained indeed improved in the newer

infrastructure of the LCRN.


Table 1: Research Profile in North London

Section # IndicatorNetwork

value

National median and range

Minimum25thPercentile Median

75thPercentile Maximum

Size

1 Network Population (NCRN) (millions) 1.625 0.7 1.1 1.55 1.91 3

2 Cancer incidence (NCRN) 7475 3220 5060 7130 8786 13800

3Number of new cancer patients treated/year (CWT data 2012-13) 6593 3341 5762.375 7133 10257.5 14542

Funding 4 NCRN funding (Core + Research and Capability Funding) (£) 719,482.00 341,390.00 516,920.00 677,725.50 832,417.50 1,220,216.00

FundingManagement

5 Financial returns submitted on time (Y/N) Y All returns submitted on time

6 Spend to approved NCRN Core budget 600,312

7 Spend to approved Research and Capability Funding budget 119,170

Staffing

8 Total wte NCRN funded staff 12.93

9 Total wte CLRN funded staff 22.82

10 Total wte staff funded from RCF in 2012-13 5.9

11Total wte other staff supporting NIHR CRN cancer portfolio in2012-13 96.16

Portfolio

12Number of NIHR CRN non-commercial cancer portfolio studiesopen 251 LRN Self-reported

13 Number of NIHR commercial cancer portfolio studies open 58 6 18 30 44.75 100

14Proportion of total NIHR national cancer portfolio open andrecruiting 25.0 7.7 10.6 17.1 21.3 36.3

15Number of NIHR studies open to recruitment with norecruitment 154 LRN Self-reported

16Return rate for expressions of interest for NIHR CRNcommercial studies 9.5 2.7 9.5 18.3 28.7 44.6

17Response rate for Company Identified Site Reviews for NIHRCRN commercial studies 59.6 0.0 40.2 53.7 64.2 83.3

PortfolioDelivery 18

HLO 1 Total number of participants recruited (NIHR cancerportfolio studies) 2118 544 1146.5 1855 2683.5 25695


# IndicatorNetwork

value

National median and range

Minimum25th

Percentile Median75th

Percentile Maximum

19Proportion of cancer patients recruited (NIHR cancer portfoliostudies) (as % of NCRN cancer incidence) 22.4 9.1 13.9 18.0 23.5 58.1

20Proportion of cancer patients recruited to intervention studies(as % of NCRN cancer incidence) 13.0 4.7 7.6 8.9 11.5 16.4

21Proportion of cancer patients recruited to RCTs (as % of NCRNcancer incidence) 8.2 4.3 6.8 7.9 9.5 15.3

22Number of other (non-patient) participants recruited to NIHRCRN cancer portfolio studies 441 17 227.8 424 857.25 21627

23Total number of participants recruited to NIHR CRNcommercial cancer studies 115 3 28.5 54.5 83.25 273

24Proportion of cancer patients recruited to NIHR CRNcommercial cancer studies 6.6 0.6 2.5 3.9 5.4 8.4

25

Total number of NIHR CRN commercial cancer sites in the localresearch network that participated in studies which closednationally in 2012-13 15 2 6.75 10.5 13 40

26HLO 2A Proportion of NIHR CRN commercial cancer studysites within the LRN delivering to time & target in 2012-13 67% 0% 42% 55% 64% 75%

27 Proportion of studies attaining forecast recruitment 35% LRN Self-reported

28Number of studies recruiting in 2012-13 that did not have aforecast 172 LRN Self-reported

Quality

29Proportion of Cancer Research Network Peer Review Measuresmet 11-5A-102/104/105 = 100% SA Compliance (No IV Published) (CQuINs)

30 Number of NCRI Clinical Studies Group Members 45 0 2 7 16 45

31 Number of Chief Investigators for NIHR CRN portfolio studies 181 LRN Self-reported

WorkforceDevelopment 32

Attendance at regional Workforce Development Groupmeetings

0LRN Self-reported

Patient &PublicInvolvement

33 Number of CLG members (Full and Associate members) 4 0 1 3 4 10

34Proportion of survey respondents from across the networkreporting having discussed research (Q27) 40.07 23.4 28.8 30.3 35.5 51.8

Organisation and Development of the Network


Section 1: Organisation and Development of the Network

The North London Cancer Research Network was established in 2002 and serves a

population of 1.625 million people. The Network is comprised of seven acute Trusts,

University College London Hospital (UCLH), Royal Free Hospital (RFH), Whittington Hospital

(WH), North Middlesex Hospital (NMH), Barnet and Chase Farm Hospitals (BCFH), Great

Ormond Street Hospital (GOSH) and Princess Alexandra Hospital (PAH). Three hospitals

(UCLH, RFH and NMH) provide radiotherapy services for their populations and surrounding

areas. Our Network Constitution has a yearly review, the current version is NLCRN

Constitution v4.0 07/08/2012.

Locally there is also an Experimental Cancer Medicine Centre based at UCL as well as an

NIHR supported Clinical Research Facility. Six of the seven trusts within the network are

contained within the Central and East London Comprehensive Research Network with PAH

being located within the Essex & Herts Comprehensive Research Network. The NLCRN

coordinates cancer clinical research and facilitates study set-up and delivery across all

seven sites.

The NLCRN has seen a steady increase in recruitment across an increasingly balanced

portfolio of trials since being established in 2002. The core management team and clinical

lead have a comprehensive oversight of activity within the network, and meet regularly to

discuss staffing, activity, portfolio balance and other relevant topics. Our Steering Committee

meets 3 times a year to discuss recruitment and current developments. These meetings are

attended by the core management team, a representative from each Trust and two

consumer representatives.

The joint management structure that exists between the NLCRN and the UCL ECMC has

allowed for more efficient use of staffing resources across both organisations. This has

facilitated the co-development of processes and the use of a single system for data capture

and analysis on EDGE. The joint structure has also opened up other benefits for the

research network such as provision of our office space by the University and access to

University meeting rooms for local use and also for the wider pan-London meetings. The

staffing model is mixed with a centralised core team which is led by Dr John Bridgewater

(Clinical Lead) and Dr James Lydiard (Senior RNM). The Industry Manager Christine

Menzies works collaboratively across the South West London Cancer Research Network

and the NLCRN. Aderonke Adebiyi started in post in September 2012 as Lead Nurse/RNM,

job sharing the RNM post with Masuma Harrison. As Lead Nurse for the network, Aderonke

leads on the development of the centralised Data Manager and Clinical Trial Practitioner

roles as well as providing support to sites and acting as the educational link for the wider

Network. The cancer research network workforce is multidisciplinary with all staff working as

integrated teams at various sites irrespective of funding sources.

There has been no significant change in the make-up of the team. There were 18.84WTE

centrally appointed team and 100.14WTE appointed directly by Trusts in a devolved manner.

Staff turnover has been a challenge this year. This in turn has affected recruitment in certain

tumour groups, which has meant that we have had to put some trials on-hold until staffing

numbers have improved (for full details see section 3 Workforce).The structure and

relationships are depicted in Figure 1.



Key areas of development this year have focused on collaborative working with the North

East London (NEL) network due to the changes within the provider network, working with

UCL Partners and working with the CELCLRN LCRN Pilot.

Underperformance in the commercial portfolio has been highlighted in previous years. The

emphasis this year has been placed on ensuring that studies deliver to time and target. The

Industry Manager has been working closely with research teams, Principal Investigators and

R&D Personnel to improve the set-up timelines and feasibility process; to assist with the

Harmonisation project for NIHR commercially adopted studies to gain NHS permissions; to

actively performance manage recruitment targets in order to ensure that targets are met (see

section 2: Portfolio and Recruitment Overview 2012-13).

Cancer services for children and young adults in the network are provided by UCLH and

GOSH Principle Treatment Centre (PTCS). The NLCRN has been working with both UCLH

and GOSH to facilitate the set-up of designated Paediatric Oncology Shared Care Units

(POSCUs) via shared care agreements within North London and we are working closely with

Investigators and research teams to maintain and expand the workforce wherever possible.

One of our key challenges in 2012/13 has been assisting with the set-up of the UKALL2011

trial at the two PTCs and ensuring that appropriate shared care agreements are developed

and utilised.



Legend

Network Post

Other Post

SiteFigure 1: North London Cancer

Research Network Structure Chart

Dr John Bridgewater - NLCRN Clinical

Lead (0.1WTE)

Senior Research Network

Manager (0.3WTE)

Aderonke Adebiyi NLCRN

Manager (0.5WTE) & Lead

Nurse (0.5WTE)

Christine Menzies

Network Industry

Manager (0.4WTE)

Vacant - Senior Administrator & Research

Governance Manager (1.0WTE)

Emma Douch - Clinical

Trials Assistant (1.0WTE)

Guy Schroeter - Network

QA Manager (1.0WTE)

3 x Clinical Trials Practitioners

Azmina Verjee (WH) (0.8WTE),

Vacant (BCF) (1.0WTE),Vacant

(NMH)

3 X Clinical Data Managers - Gayle

D’Souza (1.0WTE), Gita Parmar

(1.0WTE), Vacant (1.0WTE)

UCLP Medical Director – Professor

Kathy Pritchard-Jones

Dr James Lyddiard

Head of Trials UCLH

(0.7WTE)

Masuma Harrison NLCRN

& UCL ECMC Manager

(0.5WTE)

1 x Research Associate -

Rachel Taylor (1.0WTE)Emma Hainsworth – CR UK

Lead Nurse (0.9WTE)

1.0 WTE Lead Research Nurse; 1.0 WTE

Clinical Portfolio Manager; 7.6 WTE

Research Nurses; 0.5 WTE Clinical Trials

Coordinator; 5.0 WTE Data Managers; 0.5

WTE Lab Manager; 0.5 WTE Lab

Technician; 1.0 WTE Administrator

1.0WTE Cohort Manager,

1.0WTE Research Associate

0.8WTE Clinical Trial

Practitioner; 1.0WTE

Data Manager

2.0WTE Research Nurses;

3.0WTE Data Managers; 0.5WTE

Research Associate; 1.0WTE

Admin

Karen Howe (1.0WTE)

Research Manager/

Lead Nurse

4.22WTE Research

Nurses; 1.37WTE

Admin

Epping: 2.5WTE

Research Nurses

1.0WTE Research

Nurse

Angela McCadden

(1.0WTE), Research

Manager; Olu Omotayo

(1.0WTE) Portfolio

Manager

3.0WTE Team Leaders; 14.8WTE

Research Nurses; 2.0WTE Clin Trial

Practitioner; 0.4WTE

Radiographer; 5.6WTE Data

Managers; 2.0WTE Admin

2.7WTE Research

Nurses; 2.0WTE Clin

Trials Practitioners;

3.0WTE Data

Manager; 1.0WTE

Admin

Lydia Ward/Laura Favero

(0.7WTE), Jo Hargroves

(0.4WTE) – Haematology

Research Managers

Aryana Chopra (0.5WTE);

Zoe Wood (0.5WTE) –

Oncology Research

Managers

UCLH Clinical Research Facility

University College London

HospitalRoyal Free HospitalWhittington HospitalPrincess Alexandra HospitalsNorth Middlesex HospitalGreat Ormond Street Hospital

Barnet and Chase Farm

Hospitals

Devolved network staff:

1.0WTE x Research Nurses,

0.5WTE Data Manager

Devolved network

staff: 1.0WTE x

Clinical Trials

PractitionerDevolved network staff:

1.0WTE x Research Nurses,

0.8WTE Clin Trials

Practitioner

12.6WTE Research Nurses;

6.0WTE Clin Trial

Practitioner; 3.0WTE Data

Managers; 2.0WTE Admin


Harlow: 0.5WTE x Research

Nurses, 0.8WTE Clin Trials

Practitioner; 0.5WTE Data

Manager


0.5WTE Data Manager


0.6WTE Data Manager



Challenges

One of the challenges faced by NLCRN this year has been the adoption of a collaborative

network approach to both planning and delivering of the portfolio by providing joint research

reports (North London and North East London) to all pathway boards in London Cancer

giving a detailed overview of recruitment activity and the delivery of studies to time and

target.

The Harmonisation project pilot has been challenging this year. Two weekly meetings were

instigated by the Networks Industry Manager to improve on communication for all involved in

the pilot.

R&D approval timelines continue to be a challenge for the research network. Network staff

attend weekly R&D meetings at UCLH where updates are provided on the status of

governance checks, costing and contracts. This has resulted in a significant improvement in

the communication with R&D.

The workforce had a period with a considerable number of vacancies due to high staff turn-

over which in turn impacted on recruitment.

Children’s Cancer and Leukaemia Community

The service for younger patients in North London is complex with under thirteen’s generally

being treated at Great Ormond Street Hospital for Children NHS Foundation trust (GOSH)

and over thirteen’s being treated within the Teenage and Young Adult service at UCLH. This

year the NLCRN has been focusing on the opening of the UKALL 2011 study and has been

working closely with both sites, as well as ensuring that comprehensive support is available

for efficient study set up at the shared care centres, where maintenance therapy using IMPs

is delivered.

Over the past year we have had a series of meetings with UCLH and GOSH aimed at

formalising the relationship for study conduct between each Principle Treatment Centre

(PTC) and its associated Paediatric Oncology Shared Care Units (POSCUs) via a shared

care agreement. Both PTCs have opened UKALL 2011 to recruitment and agreed the

wording of the agreements this year. The process of sign-off for agreements is being

facilitated by the Network.

The NLCRN office has also assisted with the set-up of more routine study arrangements

including input from the Industry Manager in the joint set-up of a commercial study across

UCLH and GOSH. We have worked to enable GOSH to collect data on EDGE which would

give us uniform network-wide informatics on cancer clinical trial activity for the

area. Additionally, in response to a number of issues raised at GOSH, the Quality

Assurance (QA) Manager has been involved in supporting the teams to develop preventative

action plans to ensure study protocol compliance and quality delivery.



Interaction with Cancer Service Network

Following the review of cancer Networks in London, the remit of the Clinical Cancer

Networks for North and North East London have been merged to form an Integrated Cancer

System from London Cancer. This organisation is led by UCL Partners (UCLP) which was

formed from an alliance of all the Trusts within North and North East London. The Tumour

Advisory Boards were replaced this year by Tumour specific Pathway Boards led by a

Clinical Pathway Director with the remit of service configuration and management of

developing service across the single Network. Each Pathway Board has a research

representative tasked with highlighting and promoting research across the network.

The aim of London Cancer is to improve outcomes and experience for cancer patients in

North Central and North East London by providing a whole systems approach for patient

care. This new way of working will strengthen the support for promoting clinical trial

participation across the whole network and foster closer working between the NLCRN with

and the NELCRN.

We have adopted a collaborative network approach to both planning and delivery of the

portfolio by providing joint research reports (NLCRN & NELCRN) which provide a detailed

overview of recruitment activity according to time and target. Underperforming studies are

also highlighted and one of our aims this year has been to work with the research teams to

identify key barriers to recruitment and to provide a visual overview of the availability and

diversity of trials across the NLCRN and NELCRN. We have also locally developed the

national trial maps to span both networks in order to facilitate discussions.

In 2012, UCLP commissioned a new initiative, known as the Harmonisation Pilot, to

streamline and reduce the time taken to receive NHS Permissions for commercial studies

across all UCLP NHS organisations. The initiative is currently being piloted (due to end May

2013). Four Permission Centres (each with responsibility for the approval of specific clinical

areas) conduct the approval of commercial studies on behalf of all participant sites across

UCLP. The initiative has introduced standard, consistent costs and contracts as well as

unified submission requirements. In addition, coordinated approvals for pharmacy, imaging

and other support services have been introduced. UCLH is 1 of the 4 permission centres,

alongside Barts Health, GOSH and NoClor, and is responsible for the approval of a large

and complex portfolio, including all cancer and neuroscience trials.

Cancer clinical trials are becoming increasingly complex and are targeting smaller, more

closely defined disease subgroups. This has inevitably led to an increasing number of trials

in order to maximise opportunities for patients. Achieving objectives such as completing

trials on time and to target; recruitment of the first patient into a study within 30 days on

approval on SIV date and increasing the number of research participants has become more

dependent on collaborative network-wide working. The network has encouraged research

teams to collaborate on studies where one site acts as a Patient Identifier Centre (PIC) in

order to improve intra-network referral. This has worked well for the breast study

SUPREMO where patients were identified at WH and referred to UCLH for treatment and

then followed-up back at WH. This has also worked well for the head and neck study PET-

NECK with collaboration between NMH and BCFH.



Peer Review

The research network self-assessed in the 2012-13 year and deemed itself compliant with all

measures. Previous recommendations have been consistently reviewed every year, such as

the NLCRN organogram which has been updated to reflect how the centralised team

supports the network sites. Please refer to Table 1: Research Profile in North London, item

29 for the score according to CQuINs.

The Network PPI Lead worked and led the PPI Open Day on the 28th April 2012 (see section

4: Patient & Public Involvement). The work programme and the annual report were agreed

by the Chair of the Cancer Research Network single group and the Chair of the Network

Board. The Service Level Agreements with all Trusts are in place. Steering Committee

meetings were held over the year.



Interaction with Other Research Infrastructure

During the year 2012/13 the NLCRN has continued to support the merged management of

the NLCRN and the UCL ECMC. The UCL ECMC continues to fund an additional 1.0WTE

post providing further opportunities for collaborative working with the network. This includes

the set-up of studies and collection of data on EDGE. The management team continue to

host monthly ECMC management meetings and quarterly ECMC board meetings.

The NLCRN ensures that Network staff work cohesively with Trust-based research teams so

that all staff and Investigators working on NIHR portfolio research work in a consistent and

collaborative manner.

The North London Cancer Research Network continues to work closely with Central and

East London CLRN which covers six of the seven hospitals within the network. Princess

Alexandra Hospital falls under Essex and Hertfordshire CLRN and this year we have strived

to build relationships with the EHCLRN via a series of meetings looking at the set-up and

approval of studies via their feasibility process.

Interaction with other local topic research networks has been hosted by the CEL CLRN and

attended by network managers. Our main focus this year has been discussions around the

local implications of the NIHR governance review, transition arrangements and the

development of the CEL LCRN pilot. There have been regular meetings with the CEL CLRN

team for the development of the pilot and the Senior RNM has been involved in informing

some of the detailed plans as a member of the pilot board.

The Senior RNM or RNM attends the Pan-London and South of England network regional

meetings. These are held at the NLCRN offices in central London, providing an easily and

accessible location for participants. These meetings provide an essential forum for

discussion of common topics and, this year they have focused on the Governance review.

Training continues to be collaborative with the other cancer research networks across Pan-

London and SE England (see section 3 Workforce Development).

The joint appointment of the Industry Manager with the South West London Cancer

Research Network has helped to improve the feasibility process and highlighted the

importance of recruiting to target for commercial studies. The Industry Manager has also

been involved in developing key training for staff working within CEL CLRN aimed to

improve the feasibility, performance and costing of commercial studies in relation to the

UCLP harmonisation project.

Due to the Cancer Network provider functions being managed through London Cancer as

well as the development of the CEL CLRN LCRN Pilot, the North London and North East

London networks have worked more closely together. We have collaborated by jointly

providing data on key metrics and developing joint portfolio maps for Pathway Boards. This

has been possible by attending regular meetings with London Cancer and NEL Cancer

Research Network.

We have developed strong links with the NIHR CRF based at UCLH. All NIHR trials that are

run through the CRF are set up by the NLCRN office with additional support for the set-up of

commercial studies from the Industry Manager and the Early Phase Cancer Portfolio



Manager. The CRF focuses on early phase trials and the links with the CRF are extremely

well defined through the relationship with the UCL ECMC.

Financial Statement

The core budget for the North London Cancer Research Network for 2012-13 was £600,312

with Research Capability Funding of £119,170. The expenditure for the same period was the

full amount of £719,482.

The NLCRN was able to utilise in full all of the core and RCF financial allocation in 2012-

13. There remains the on-going issue of managing the network within a flat budget as the

on-going cost pressures of incremental drift cannot be accounted for within core

funding. This is particularly relevant as the more senior posts (band 6 and above) tend to be

relatively stable with staff staying in post for an average of 3 plus years. The on-going

burden of accounting for incremental drift without annual increases means that to-date

1.21WTE of substantive posts (a decrease of 0.71WTE from 2011/12) have been reduced

from the core budget. This will continue to impact in the coming years. We would estimate

that over the next 12 months we will need to lose the equivalent of a further 0.5WTE of posts

due to this process which will have inevitable consequences for activity/quality levels.

Further to the core budget, during 2012/23 the NLCRN managed £1.3M of CLRN funding

related to service support costs across our member organisations. This approach has

allowed ring fenced of funding for cancer trials could be appropriately directed to support the

large NIHR portfolio of cancer trials.

Portfolio and Recruitment Overview 2012-13


Section 2: Portfolio and Recruitment Overview 2012-13

Table 2: Total Annual Recruitment 2001-13

Year Patients Other recruits Total

participantsRCT non-RCT

Incidence Number % of

cancer

incidence

Number % of

cancer

incidence

Other

RCT

Other

non-

RCT

2001-2 6440 202 3.1 17 0.3 0 0 219

2002-3 6440 166 2.6 87 1.4 0 0 253

2003-4 6440 314 4.9 263 4.1 0 0 577

2004-5 6440 395 6.1 369 5.7 1 178 943

2005-6 7475 380 5.1 315 4.2 1 108 804

2006-7 7475 374 5 170 2.3 5 170 719

2007-8 7475 668 8.9 200 2.7 22 408 1298

2008-9 7475 580 7.8 642 8.6 127 468 1817

2009-10 7475 597 8 557 7.5 61 1319 2534

2010-11 7475 819 11 635 8.5 102 371 1927

2011-12 7475 771 10.3 862 11.5 9 189 1831

2012-13 7475 613 8.2 1064 14.2 2 439 2118

Definitions:

“Patient”- recruits with cancer or a pre-malignancy. Contributes to the delivery of NCRN

national targets for the proportion of cancer patients recruited to the portfolio as well as

NIHR Clinical Research Network High Level Objectives.

“Other” participant - recruits without cancer or a pre-malignancy (includes case controls,

recruits to screening/prevention/diagnostic studies). Contributes to delivery of NIHR Clinical

Research Network High Level Objectives.

“All participants”- includes all recruits regardless of disease status. Contributes to delivery

of NIHR Clinical Research Network High Level Objectives.



Overall recruitment for 2012-13 was 15.7% higher than 2011/12, representing significant

growth. The total number of participants in studies reached the second highest level ever

achieved in over a decade, at 2118 subjects. 287 more participants were recruited to studies

in 2012-13 compared to 2011-12 (see Figure 2: RCT versus Non-RCT Recruitment 2001-

13).

During 2012-13 there were 209 studies recruiting, of which 113 were RCTs and 96 were

non-RCTs. In 2012-13, 8.2% of the network’s cancer incidence was recruited into RCTs,

compared to 10.3% in the previous year. In addition, 14.2% of cancer incidence was

recruited into non-RCT studies in 2012-13, compared to 11.5% in 2011-12. This

unprecedentedly high level reflects the achievement of a key objective to increase

recruitment into non-RCT studies.

Figure 2: RCT versus Non-RCT Recruitment 2001-13

In total, there were 165 fewer recruits to RCTs in 2012-13 compared to the previous year,

whereas there were 452 more recruits to non-RCTs. The decline in recruits to RCTs was

anticipated since no new high-recruiting RCTs were due to open in 2012-13. Given that a

small reduction in RCT activity was foreseen, there was a concerted and successful drive to

increase recruitment within the non-RCT portfolio.

Non-RCT recruitment this year is the highest ever achieved for the network, exceeding the

one thousand mark (1,064). High recruiting non-RCT studies included Tumour

Angiogenesis (a validation of outcome measures study in colorectal cancer), the CNS 2004

10 Functional Imaging of Tumours study in childhood cancer, and several genetics studies

such as SEARCH, BOCS (formerly named FBCS) in breast cancer, CORGI and NSCCG in

colorectal cancer, UKGPCS in prostate cancer, and NSHLG in lymphoma.

0

500

1000

1500

2000

2500

3000

Other non-RCT

Other RCT

non-RCT

RCT



Going forward, it will be important for the network to identify appropriate RCTs to replace

those which close, in order to sustain activity and maintain balance across the different

tumour groups. For example, in 2013-14 FOCUS4 will open within the colorectal tumour

group which is expected to be a high recruiting RCT and also contribute to the non-RCT

activity.

As the clinical trials landscape shifts towards biomarker-driven stratified (personalised

medicine) designs, the network’s RCT versus non-RCT recruitment profile is likely to evolve

further.

Clinical Studies Group (CSG) Performance 2012-13

The year of 2012-13 has been excellent for recruitment overall, with particular emphasis on

Breast, Prostrate, CCLG and Upper GI portfolios, all showing a significant increase in

recruitment.

Figure 3: Local Research Network Overall Yearly Recruitment by CSG (Improved CSG

2012-13)

Predicted recruitment within the breast portfolio was achieved this year, with the highest

number of participants being recruited into this portfolio. Import High, the radiotherapy breast

study and BOCS, a non-randomised study made up the majority of the total recruitment. We

would expect to see recruitment to breast studies increase further in the coming year due to

the opening of Targit B. Recruitment into CCLG dropped last year with a total recruitment of

82 patients; however, recruitment this year has more than doubled with a total recruitment of

173 patients. This is in part due to studies reaching or exceeding their forecast target. There

was a slight dip in recruitment in the colorectal group last year but this has picked up again

in 2012-13, this can be attributed to the Tumour Angiogenesis and Corgi studies that

contributed significantly in the total recruitment. It is anticipated that with new key studies

0

100

200

300

400

500

Bre

ast

CC

LG

Co

lore

ctal

Pro

stat

e

Up

pe

rG

I

2007/08

2008/09

2009/10

2010/11

2011/12

2012/13



(FOCUS-4) opening in the coming year, recruitment will continue to increase. Activity to the

prostate portfolio continues to improve with a high proportion of patients being recruited into

the Non-RCT study PROMIS (prostate MRI imaging Study) and several focused in

diagnostic studies. Recruitment to the Upper GI Portfolio has increased further this year

although it was anticipated that recruitment would fall due to the closure of a number of

studies in 2011/12. However, a number of trials including the BOOST trial for Barretts

Oesophagus have performed strongly to compensate for this.

A steady increase in the head and neck cancer portfolio has been seen this year, although

recruitment figures are still relatively small in comparison to some other tumour types as only

a few trusts within our network specialise in this area. The LEONIDAS2 study has been the

major recruiter for head and neck, with over 30 patients registered since opening at the

beginning of the reporting year, accounting for over half the total recruitment in this tumour

group.

Recruitment to renal trials has seen a substantial decrease due to the two highest

performing trials closing to recruitment in January this year. The Sorce and Transource

studies accounted for over 80% of the total renal recruitment, thus their closure has a

significant impact on the figures. A slight decrease was also seen in haematology trials,

which can be attributed mainly to the closure of AML16 in May 2012. There are currently a

large number of trials in set-up in the haematology portfolio, so it is anticipated that this will

increase in 2013-14.

As predicted last year, the opening of the new locally developed CanTalk study along with

the Biliary Tract Cancer Quality of Life Validation study has resulted in increased activity

within the psychosocial area of research. As this was previously a severely

underrepresented area of the portfolio, hopes are high for the future despite current

recruitment figures still being relatively low. Further work is needed to ensure that the

CanTalk trial will successfully complete in 2013/14.

A number of trials were opened this year across multiple sites within the network. For

example Streamline L and Streamline C, imaging studies with high potential recruitment in

lung and colorectal respectively have been set-up at three different sites. This has

contributed to the increase seen in colorectal figures; however the closure of the extremely

successful Lung-BOOST in 2011-12 has resulted in the impact of opening Streamline L

being less noticeable. Also currently in set-up is FOCUS-4, an umbrella trial for testing novel

agents for colorectal cancer, due to be running across five sites within the network and

predicted to be available to a large patient population. It is therefore hoped that the impact of

this trial will be noticeable in next years’ figures.

The report presents data on all NIHR CRN studies that the network supports; thisincludes studies which are jointly supported and resourced by other parts of NIHRCRN.



Performance against forecast recruitment 2012-13

Table 3 below summarises the recruitment forecast against actual recruitment for 2012-13.

Appendix 1 shows the full list of portfolio and recruitment for 2012-13 (compared against

forecast recruitment). Forecasting for 2012-13 was conducted using the UKCRN database

data, predicted annual accrual captured on the SSI, previous recruitment 2011-12,

anticipated opening date and study closure date. More than half of the portfolio which had

forecast figures performed well (classified as green or amber) with just under a quarter of the

portfolio underperforming against targets. Details for reasons are highlighted in Table 4.

Table 3: Summary of Forecast Activity

Total forecast recruitment for 2012-2013 1581

Total actual patient recruitment 2012-2013

2118

Total number of studies recruitmentpredicted

185

Number ofStudies

Reason for Performance

Recruited at least 90% offorecast

57

Of the 57 studies, 29 were interventional RCTs. The RCTstudies which exceeded the expected recruitmentincluded STAMPEDE, RATHL, The LEONIDAS2 study,SCOT and IMPORT HIGH. One of the contributing factorsto the success of studies such as STAMPEDE and SCOTare that they are open at 5 sites across the network.Non-RCT studies which performed well include TumourAngiogenesis, BOCS (FBCS), CORGI and PROMIS.

Recruited to 66-89% offorecast

16The majority of these studies were breast, lymphoma,haematology and sarcoma. Some studies that wereclose to target include ESSG1, PACIFICO and REACT.

Recruited less than 65%of forecast

42

Compared to 2011-2012, a smaller proportion of studieswere below target recruitment compared to those thatmet target. There are many factors contributing to thisperformance figure, with 31% of these studies closingduring the reporting period and studies being put onhold during set-up due to staff shortages at a number ofsites; unfortunately this is a factor we are unable tocontrol. However, an area the NLCRN have beenfocusing on is working closely with R&D to assist instreamlining the study approval process through newprojects like the Harmonisation Project.



Delivery of NIHR CRN adopted commercial studies 2012-13

During 2012/13, the Industry Manager (IM) was focusing mainly on the feasibility process

and the performance management of the open trials. She worked closely with CIs, PIs and

research teams to make sure the feasibility process was as robust as possible and set up a

detailed spread sheet to track dates of receipt and deadlines for responses for both

‘Expressions of Interest’ and ‘Network checks on pre-selected sites’ in line with national

requirements. In terms of performance management of open commercial trials, the IM has

been in close contact on a regular basis with teams across NLCRN who were

underperforming according to time and target and has worked with the PIs and their

research staff to suggest ways to make sure their trials are delivered on time.

The IM worked very closely with personnel from the CEL CLRN and Liaison Officers from

the UCLH R&D Permission Centre to help ensure a smooth and quick approval process for

the commercial trials through the UCL-P Harmonisation process. The IM met with the

external consultant who lead the harmonisation project to discuss suggested time points to

be captured and also in line with the new process, set-up and ran three training courses for

research staff across CEL CLRN on topics ranging from ‘’The Feasibility process for network

trials’’ to ‘’Performance Managing trials’’.

The year has seen almost a doubling in the number of commercial trials that closed to

recruitment, 15 trials closed this year compared to only 8 last year. The performance has

also improved dramatically, from 25% to 67% completing to time and target with the best

performing areas being haematology, lymphoma, colorectal, renal and gynaecological

cancer. Five trials did not manage to achieve target last year, the reasons are detailed in

appendix 2. The volume of commercial trials has significantly increased with the number of

open trials being 47 as compared with 27 in the previous year. This increase in activity is

across the range of tumour types.

Lymphoma and lung were two specific areas where extra support from the NLCRN was

required in order to make sure the trials were delivered to time and target. As detailed under

the ‘Additional Initiatives’, the IM assembled a newsletter summarising all the open

commercial lymphoma trials and key contacts which was circulated to all the relevant staff

across NLCRN to try and increase referrals for underperforming trials. Within the lung

portfolio, the IM initiated the set-up of a specialised group of commercially active consultants

within the network to encourage a more open and transparent feasibility process. The

objective of the group is to ensure that the most appropriate site(s) are nominated for

selection in the knowledge that the other sites within the network would refer patients to a

single site.

Following on from 2011/12, UCLH as a green shoot site for prostate cancer is now recruiting

well to NCRN 322 TERRAIN. During 2012/13 Barnet and Chase Farm were put forward as

a green shoot site for prostate and bladder observational trials but as yet no appropriate

studies have been established at site.

On-going active management of the commercial portfolio by the IM has significantly

contributed to the improvement in this priority area.



Balance of Portfolio table

Table 4: Table of trust and network portfolio, recruitment of participants benchmarked to national performance 2011-12

Local Research Network totals compared to NCRN median

CSG Indicator Network total NCRN lowest NCRN RANGE (graphic)NCRNhighest

BladderCancer

Intervention

Numberstudies

2 0 8

Recruitment 12 0 29

Brain TumourIntervention

Numberstudies

5 0 5

Recruitment 18 0 22

Observation

Numberstudies

1 0 2

Recruitment 22 0 535

Breast CancerIntervention

Numberstudies

17 7 27


Observation

Numberstudies

6 1 17


ColorectalCancer

Intervention

Numberstudies

9 1 14


Observation

Numberstudies

3 1 6


GynaecologicalCancer

Intervention

Numberstudies

6 0 10


Observation

Numberstudies

2 0 4

Recruitment 9 0 64



CSG Indicator Network total NCRN lowestNCRN RANGE

(graphic) NCRN highest CSG

HaematologicalOncology

Intervention

Numberstudies

29 3 31


Observation

Numberstudies

2 0 5

Recruitment 9 0 652

Head and NeckCancer

Intervention

Numberstudies

6 0 9


Observation

Numberstudies

1 0 4


Lung CancerIntervention

Numberstudies

5 0 18


Observation

Numberstudies

1 0 5


LymphomaIntervention

Numberstudies

13 0 14

Recruitment 70 0 76

Observation

Numberstudies

2 1 3


MelanomaIntervention

Numberstudies

1 0 5

Recruitment 3 0 21

Observation

Numberstudies

2 0 4

Recruitment 12 0 55

ProstateCancer

Intervention Numberstudies

5 1 17



CSG Indicator

CSGIndicator Network total NCRN lowest

NCRN RANGE(graphic)

NCRN highestCSG


Observation

Numberstudies

3 1 5


Renal CancerIntervention

Numberstudies

5 0 8

Recruitment 22 0 65

Observation

Numberstudies

0 0 2

Recruitment 0 0 115

SarcomaIntervention

Numberstudies

5 0 10

Recruitment 37 0 48

Observation

Numberstudies

0 0 2

Recruitment 0 0 142

Testis CancerIntervention

Numberstudies

2 0 5

Recruitment 8 0 36

Observation

Numberstudies

0 0 3

Recruitment 0 0 190

Upper Gastro-IntestinalCancer

Intervention

Numberstudies

16 1 19


Observation

Numberstudies

3 0 5





All ClinicalStudies Groups

Intervention

Numberstudies

0 0 1

Recruitment 0 0 125

Observation

Numberstudies

1 0 2

Recruitment 1 0 105

Biomarkersand Imaging

Intervention

Numberstudies

0 0 1

Recruitment 0 0 4

Observation

Numberstudies

0 0 2


Children'sCancer andLeukaemia

Intervention

Numberstudies

10 0 12

Recruitment 53 0 56

Observation

Numberstudies

4 0 6


Palliative &Supportive

Care

Intervention

Numberstudies

0 0 3

Recruitment 0 0 54

Observation

Numberstudies

1 0 4


Primary Care

Observation

Numberstudies

0 0 2

Recruitment 0 0 945

PsychosocialOncology

Intervention

Numberstudies

1 0 3

Recruitment 4 0 63




Observation

Numberstudies

1 0 5

Recruitment 5 0 309

RadiotherapyIntervention

Numberstudies

0 0 4

Recruitment 0 0 42

Observation

Numberstudies

1 0 2

Recruitment 5 0 112

Teenage andYoung Adults

Observation

Numberstudies

1 0 2

Recruitment 21 0 58

Grand totalIntervention

Numberstudies

137 36 191


Observation

Numberstudies

35 10 59


Key

25 - 75th Percentile

Individual Network Total

NCRN Median



Table 4 summarises the performance of the NLCRN in relation to the median (and range) of

studies across the NLCRN divided by CSG.

The overall total number of studies open to recruitment during 2012/13 increased slightly

compared to the previous year, from 165 to 172 (137 interventional plus 35 observational

studies). This is higher than the NCRN median, with the highest network having a total of

191 studies. Looking at the number of patients recruited to interventional trials, 1177 patients

were entered this year, this figure was again higher than the NCRN median, the highest

number entered for any network was 1457. Unfortunately the number of patients locally

entered to observational studies was less than the NCRN median (938 patients were

entered within NLCRN despite the fact that there were more observational studies open

compared to the rest of the country), a review of performance to this area is needed for the

forthcoming year.

Within many key areas the portfolio does very well with respect to recruitment of the 23

CSGs. The following groups all recruited more than the national median to the interventional

studies: bladder, brain, gynaecological, haematology, head & neck, lung, lymphoma,

melanoma, prostate, sarcoma, testis and upper GI, children’s cancer and leukaemia and

psychosocial oncology. Within this group, brain, haematology, lymphoma, prostate,

sarcoma, upper GI and children’s cancer and leukaemia performed particularly well.

Looking in detail at the observational studies however only 8 CSGs recruited more than the

NCRN median: colorectal, breast, gynaecological, prostate, upper GI, palliative & supportive

care, children’s cancer and leukaemia and teenage and young adults. Tumour groups that

have potential for improvement through extending activity to observational trials include:

haematological oncology (only 9 patients were entered to 2 trials compared to the highest

network entering 652 patients to 5 trials); head & neck cancer, lung cancer, all clinical

studies group, psychosocial oncology and radiotherapy (only 5 patients entered compared to

the 112 patients in the highest recruiting network).The NLCRN is actively engaged with PI’s

and relevant trusts to develop and maximise the portfolio in these areas to improve on future

activity.

Looking at both interventional and observational studies together, only a very small number

of CSGs managed to perform well across both these types of trials: children’s cancer and

leukaemia, gynaecological, prostate, and upper GI cancers with the best performance.

The Network’s centralised staff work closely with the Trusts to facilitate study set up

prioritising those studies that could impact on recruitment.



Trust Performance 2012-13

The NLCRN plays a key role in performance management of trials across the network and has an in-depth overview of the portfolio. The Senior

Trials Administrator and Clinical Trials Assistant are responsible for the local set-up of all NIHR studies and work closely with the research

teams to identify appropriate studies. Studies are promoted locally via research reports which are disease specific and provide detailed

information on recruitment targets. Figure 4 summarises achievements by Trust and shows that UCLH contributes approximately 50% of the

annual participation.

Figure 4: Annual Participant Recruitment by Trust (2010-11, 2011-12 and 2012-13)

0

200

400

600

800

1000

1200

20

10

/11

20

11

/12

20

12

/13

20

10

/11

20

11

/12

20

12

/13

20

10

/11

20

11

/12

20

12

/13

20

10

/11

20

11

/12

20

12

/13

20

10

/11

20

11

/12

20

12

/13

20

10

/11

20

11

/12

20

12

/13

20

10

/11

20

11

/12

20

12

/13

20

10

/11

20

11

/12

20

12

/13

BCFH GP GOSH NMH PAH RFH UCLH WH

Other: non-RCT

Other: RCT

Patients: non-RCT

Patients: RCT



Barnet and Chase Farm Hospitals NHS Trust

Figure 5A: Summary of Portfolio Activity & Key Achievements 2012-13

The breast portfolio remained the strongest area for recruitment in 2012-2013, representing

44% of recruitment at BCFH. Lung studies accounted for 15% of recruitment, having

increased from 2% the previous year. Lymphoma and Colorectal trial recruitment have also

increased from the previous year. Haematology trials showed the greatest reduction in

activity, falling from 30% to 4% of the portfolio. Overall, recruitment increased slightly from

the previous year, rising from 53 to 54 patients despite gaps in staffing through the year.

The BCFH team have opened around 10 new portfolio trials since April 2012 and one of the

highlights of the year for the team has been working on trials in new areas such as prostate

cancer. The STAMPEDE prostate study and the OPTIMA breast study have been the Trusts

top recruiting trials this year, since opening to recruitment in 2012.

The research department spent 6 months of the last year with only 1 part time Clinical Trials

Practitioner and 2 months without a Data Manager. This had a serious impact on its ability to

support clinicians to recruit patients into the newly opened trials. This particularly hampered

recruitment to Haematology trials.

Recruitment to the ET lung study was hampered by the inability to give chemotherapy to

lung cancer patients at Chase Farm Hospital. Chase Farm patients were referred to NMH or

Barnet Hospital if they wanted to take part on the ET study.

The NLCRN lead nurse has continued to work with the CTP and Data Manager at site

throughout the year providing support. As clinical support is provided from the Mount Vernon

Network, there is additional NIHR activity that takes place at site but contributes towards

Mount Vernon activity.

Breast44%

Colorectal4%

Haematology4%

Head and Neck7%

Prostate15%

Lymphoma11%

Lung15%

Figure 5A: Barnet and Chase Farm Hospitals NHS Trust recruitment ofparticipants for 2012/13 by CSG



Table 5A: Patient Referral from BCFH to other NLCRN Trusts 2012-13

Referring Hospital Site Patient Referred toPatientTotal

Examples of mostcommon trial referrals

Barnet & Chase FarmHospitals NHS Trust

North Middlesex Hospital 5 STAMPEDE, RADICALS

Royal Free Hospital 13 TRANSORCE, SORCE

University College LondonHospital

16 PICTURE, PROTEC3

TOTAL 34

Focus for 2013-14

The NLCRN aims to recruit another CTP to work with existing staff at BCFH and there will

also be an addition of another data manager to join the team, enabling all new trials to be

covered and ultimately to increase recruitment into trials at both hospitals. Several

consultants have expressed an interest in opening commercial studies; this will create a new

challenge for the team and will also provide patients with even more opportunities to enter

clinical trials. The R&D Director will be appointing an R&D manager which should help to

process governance checks for new trials and amendments even more smoothly and

quickly. A closer working relationship with the treatment centres NMH and MV to recruit

patients into suitable trials is another objective, again giving more options to patients.



Great Ormond Street Hospital for Children NHS Foundation Trust

Figure 5B: Summary of Portfolio Activity & Key Achievements 2012-13

The current portfolio at GOSH is balanced between interventional and observational studies.

Compared to last year, recruitment had an increase of slightly over 100%. This is due to the

studies CNS 2004 10 and BOCS. Activity has also increased within the colorectal group, this

is attributed to the CORGI study and 57% of activity is related to genetic studies in the family

history practice. The most significant reduction in activity was seen in the haematology group

and is predominantly due to the closure of four studies. Recruitment has also slightly

decreased in the sarcoma study STS 2006 03, the only sarcoma study open at GOSH. A

new area of activity during this period includes recruitment into the brain study AIP.

GOSH in conjunction with the NLCRN IM have successfully opened two commercially

adopted early phase studies and the number of commercially adopted studies is likely to

increase over the next few years.

During 2012-13 the team was not up to core establishment for much of the year with the

absence of team lead for 6 months. The team has extended collaboration with the GOSH

Clinical Research Facility and the trial data backlog has been significantly reduced.

The NLCRN have been in discussions with GOSH about the implementation of EDGE

version 2 and the QA Manager has also been in close contact with the team at GOSH

offering QA support to the team.

Brain2%

Breast45%

Children's Cancerand Leukaemia

35%

Colorectal12%

Haematological1%

Not Specified1%

Prostate2%

Sarcoma2%

Figure 5B: Great Ormond Street Hospital for Children NHS FoundationTrust recruitment of participants for 2012/13 by CSG



Table 5B: Patient Referral from GOSH to other NLCRN Trusts 2012-13

Referring Hospital Patient referred toPatientTotal


Great Ormond StreetHospital for Children

NHS Foundation Trust


4 BRIGHTLIGHT

TOTAL 4

Focus for 2013-14

One of the main focuses will be to develop a closer relationship with the Clinical Research

Facility in order to increase research nurse resource capacity. The relationship with the

NLCRN team in regards to trial set-up, the trial management system EDGE and

implementation of quality systems will also be placed. The introduction of an internal GCP

audit system conducted by the NLCRN QA Manager will deliver high quality research to

GOSH. A new translational research team will increase the recruitment to biological studies.

The team also plans to secure long term funding for clinical trials team core posts beyond

2014.



) North Middlesex University Hospital NHS Trust

Figure 5C: Summary of Portfolio Activity & Key Achievements 2012-13

NMH overall recruitment has reduced slightly compared to last year. However, some groups

have performed significantly well and the activity has increased in the lung group mainly due

to the NCRN248 ARCHER study. The colorectal group has also seen an increase in activity,

partly due to the SCOT study. Breast, haematology and prostate groups have also had a

slight increase in activity. The most significant reduction was seen in the upper GI studies

and can be attributed to the study closure of BOSS making an impact in the overall

recruitment which decreased by nearly 19%.

The NMH team faced some challenges this year, such as funding and maintaining contracts

in a changing and difficult financial climate; time to target and managing the Trust and R&D

expectations of oncology research nurses role. However, the team has successfully met and

exceeded the target for the ARCHER study. In 2012-13 the team celebrated the

Departments’ 20th Anniversary.

The NLCRN Lead Research Nurse has actively supported the team and the QA Manager

has implemented new SOPs in the cancer team. A Network CTP has also worked in the

NMH team over 2012-13.

Breast25%

Colorectal32%

Haematological11%

Lung20%

Prostate9%

Upper GI3%

Figure 5C: North Middlesex University Hospital NHS Trustrecruitment of participants for 2012/13 by CSG



Table 5C: Patient Referral from NMH to other NLCRN Trusts 2012-13



North MiddlesexUniversity Hospital NHS

Trust

Royal Free Hospital 2 TRANSORCE


7 BRIGHTLIGHT, mEOC

TOTAL 9

Focus for 2013-14

The NMH has just taken delivery of a brand new Linac. This will allow a focus on opening

radiotherapy clinical trials to further increase recruitment of local patients in this very

specialised field. There are plans to engage Consultants who may not have previously been

active within research. The Research Department will be participating in International Nurses

Day, presenting a stand in the hospital on Friday 10th May 2013 to highlight their roles as

oncology research nurses. In order to raise awareness across the Trust and amongst the

local community, they plan on hosting a stand in the hospital on 'International Clinical Trials'

day. They will be conducting a ‘Chocolate Trial’ to explain the concept of inclusion/exclusion

criteria and randomisation associated with participating within a clinical trial.



The Princess Alexandra Hospital NHS Trust

Figure 5D: Summary of Portfolio Activity & Key Achievements 2012-13

St Margaret’s Hospital (Epping)

Only breast studies are conducted at St Margaret’s Hospital and recruitment into studies has

remained stable in this portfolio. The non-RCT study SEARCH had another year with

significant activity. There was an increase in recruitment to commercial studies in Epping,

predominantly due to the NCRN521 4EVER UK and NCRN463 TDM1 studies. This is a

result of a closer working relationship between the Trust research team and the Network

Industry Manager.

Princess Alexandra Hospital (Harlow)

In comparison to last year, there have been no significant changes in the overall recruitment

in Harlow. There are a variety of colorectal studies; the SCOT trial continues to be the

highest colorectal recruiter. The newly opened ARISTOTLE is actively screening patients

and is anticipated to recruit a large number of patients. Prostate studies have observed a

significant increase in patient recruitment in their three studies in comparison to last year. A

slight decrease was being seen in the upper-GI and lung portfolio, mainly due to study

closures side and changes in the ET study eligibility criteria. The commercial lymphoma

study NCRN246 GALLIUM has also been successful in recruiting more patients this year.

The NLCRN has provided Lead Nurse support and the QA Manager worked to improve the

quality systems in both Trusts.

Breast68%

Colorectal17%

Lung2%

Lymphoma2%

Prostate10%

Upper GI1%

Figure 5D: The Princess Alexandra Hospital NHS Trust recruitment ofparticipants for 2012/13 by CSG



Table 5D: Patient Referral from PAH to other NLCRN Trusts 2012-13



Princess AlexandraHospital NHS Trust

University College LondonHospitals

7 ICON8, INTERLACE

TOTAL 7

Focus 2013-14

Princess Alexandra and St Margaret’s Hospitals have a portfolio in expansion. Colorectal

continues to be the group recruiting the largest number of patients in PAH. Plans for the

future include opening the studies FOCUS 4, BACCHUS and STREAMLINE C. Expanding

the portfolio of NIHR commercially adopted studies is also an area of continued development

for the NLCRN across both sites.



Royal Free Hospital NHS Foundation Trust

Figure 5E: Summary of Portfolio Activity & Key Achievements 2012-13

The team continues to be led by the Portfolio Manager and Lead Research Nurse. The

overall recruitment in 2012-13 has decreased by around 26% in comparison to last year.

However, some areas have shown relevant improvement in the recruitment numbers; the

upper-GI group had a significant increase predominantly due to the CUP ONE trial and a

couple of commercial studies. Melanoma and haematology also improved their activity over

the year, the commercial melanoma studies NCRN415 MELABIS and NCRN423

BRAF+MEK and the haematology studies AML-17 and the commercial NCRN336 are

responsible for this welcome increase. Activity in the breast study has been maintained. The

remaining areas observed a decrease in activity, renal and lymphoma showing the most

significant reduction. Recruitment to the renal study TRANSORCE had reduced by nearly

50% and the renal trial COSAK has been closed. The lymphoma study NSHLG had also

recruited fewer patients this year.

Staff turnover has been a particular challenge within the study team. Research Nurses and

Clinical Trials Practitioners working at full capacity alongside the implementation of the UCL-

P Harmonisation process has been somewhat challenging in the pilot phase but gradually

the process is being better understood and the benefits reaped. The difficulty in recruiting to

vacant posts was evident and is now being considered at Board level. The Harmonisation

project has added a new dimension to this as study set up is out pacing the ability to recruit

suitable staff. Despite this, the team open trials within 8-12 weeks of TFC discussion, and

managed to work at capacity when the unit had prolonged resources issues and therefore,

current staff number was expanded to approximately 25 members. The nursing and CTP

Breast14%

Colorectal4%

Haematological13%

Lymphoma8%

Melanoma5%

Prostate3%

Psychosocial1%

Radiotherapy2%

Renal7%

Upper GI43%

Figure 5E: Royal Free Hospital NHS Foundation Trust recruitment ofparticipants for 2012/13 by CSG



team have implemented a new strategy to cross cover in the face of sustained staffing

shortages.

The NLCRN has provided data management and QA support over 2012-13. The quality

system has been improved with the implementation of new SOPs.

Table 5E: Patient Referral from RFH to other NLCRN Trusts 2012-13



Royal Free London NHSFoundation Trust

University College LondonHospitals

4 HYMN, TRISST

TOTAL 4

Focus 2013-14

The Royal Free team aims to explore further revenue streams to increase the data

management resource available in the Oncology and Haematology Clinical Trials Unit to

ensure that trial set-up/approval timelines are kept within 8-12 weeks from TFC discussions.

One of the new objectives is streamlining the processing of commercial clinical trials

payments and invoicing. The team will work with R&D to implement a mechanism for better

allocation of clinical trial funding to service support departments. A closer working

relationship within the NLCRN, R&D, UCL-P colleagues, pharmaceutical companies, service

support departments to deliver clinical trials that will benefit patients is also expected.

The team is seeing an increasing number of novel intravenous IMP's for trial. They plan to

work closely with the chemotherapy day unit to achieve the best way of supporting

administration of these and to support trial patients treated in the off-site infusion centre at

Finchley Memorial Hospital.



University College London Hospital NHS Foundation Trust

Figure 5F: Summary of Portfolio Activity & Key Achievements 2012-13

UCLH provides the central hub for trial activity as part of the joint Cancer Centre and as such

contributes the largest proportion of patients and has the most diverse trials portfolio. There

is a close working relationship between the NLCRN office and the Cancer Clinical Trials Unit

at UCLH which is facilitated by the joint role of the Head of Cancer Trials who is also Senior

Network Manager for the NLCRN.

Overall NIHR activity has increased by nearly 14% compared to last year, with 1050

participants being recruited into trials this year. Recruitment into upper-GI and uro-surgery

studies has doubled, with a significant increase seen in recruitment into NCRN-adopted

trials. Activity within sarcoma trials is significantly lower than last year, which is explained by

the fewer number of trials that opened within the tumour group. With a further 6 sarcoma

studies in set-up, an increase in trial recruitment is anticipated over the coming year. The

increase in the lung portfolio this year is a big achievement in oncology as this was one of

the areas we aimed to develop during 2012-13. Additionally, the team is keen to increase

further activity in head & neck trials as this portfolio has improved since 2011-12.

This year the NIHR commercial portfolio has increased substantially and there are a number

of further new trials in the pipeline, working with the NLCRN IM in feasibility and set-up

ensuring that important NIHR metrics are met.

The paediatric research team continues to work with young patients and their families across

all tumour types, covering NIHR commercial and academic studies. Although the portfolio

All Clinical Groups0%

Bladder1%

Brain3%

Breast4%

Children'sCancer andLeukaemia

2%

Colorectal13%

Gynaecological3%

Haematological9%Head and Neck

4%

Lung1%

Lymphoma8%

Palliative &Supportive Care

2%

Prostate16%

Psychosocial0%

Sarcoma3%

Testis1%

Teenage and YoungAdults

2%Upper GI

27%

Figure 5F: University College London Hospital NHS Foundation Trustrecruitment of participants for 2012/13 by CSG



has seen the closure of the national leukaemia study UKALL2003, it has continued to grow

following the opening of UKALL2011 and a new NIHR commercial trial.

The past year has seen an expansion of the haematology research portfolio, particularly in

CLL. Although there has been a decrease in recruitment to NIHR studies following closure of

a particular lymphoma retrospective observational study, there has been a rise in

commercial activity. The most significant achievement this year has been the appointment of

Dr Rakesh Popat to lead in developing our portfolio of early phase studies across

haematology. Since his appointment, 5 new Phase 1/2 trials have opened, with several more

in the pipeline. To ensure a transparent and balanced consideration for academic

leadership, scientific competitiveness and patient need, we are currently piloting a Trial

Prioritisation Tool to score new trials. The transplant portfolio has also expanded and

recruitment has commenced into the first gene therapy study with a second gene therapy

study due to open in April 2013.

The management teams have been fortunate in securing funding for all staff on fixed term

contracts this year. Additionally, funding from the Al-Fayed Charitable Foundation, the

Central and East London Comprehensive Local Research Network (CEL CLRN) and a fourth

haematology data manager from a commercial company have been secured.

The team continue to work closely with the Research and Development (R&D) department to

open studies with minimal delays. This year has seen significant changes taking place in the

R&D department requiring the CCTU to adapt the current internal processes.

The NLCRN has provided extensive Data Management and QA support in 2012-13. A great

number of SOPs have been created and GCP audits have been conducted.

Table 5F: Patient Referral from UCLH to other NLCRN Trusts 2012-13



University CollegeLondon NHS Foundation

Trust

Royal Free London Hospital 1 NCRN423

TOTAL 1

Focus for 2013-14

The UCLH team plans to continue to reduce study set up times to open studies within the

nationally defined timelines and expand the trial portfolio. A continuous improvement of the

haematology trials tracker monitoring progress against planned recruitment target is

expected (with adoption in oncology if appropriate); also maintaining studies in high levels of

GCP and SOP compliance, with the ultimate aim of achieving 100 per cent for both. The

team aims to make use of the new database to capture intelligent data and use this to

improve set-up times and recruitment to time and target. Ensuring funding for existing staff

and development of the team as required by seeking all available funding streams is also

vital as well as continuing to develop the team leader roles to enhance the support available

to the team. Facilitating personal and professional development and providing portfolio

management will also take place over 2013-14.



The Whittington Hospital NHS Trust

Figure 5G: Summary of Portfolio Activity & Key Achievements 2012-13

The overall recruitment has remained stable. However, activity increased in different areas,

such as the haematology, prostate and the psychosocial portfolio. Within the prostate tumour

group, the UK Genetics Prostate Cancer Study (UKGPCS) recruited a large number of

patients. POETIC and PERSEPHONE continued to recruit, but the closure of TARGIT-A and

REACT has reduced the number of patient participants to breast trials. The activity within the

colorectal tumour group increased with twelve patients in 2012-13. Within the lung tumour

group, MALCS continued to recruit patients; however, accrual to the ET Trial fell after a

major eligibility amendment excluded all patients with squamous histology. The cross-cutting

psychosocial study CanTalk opened to recruitment and the first patient was randomised. In

addition, the PulMiCC trial opened after significant delays. Finally, the BRIGHTLIGHT

Teenage & Young Adult study opened to recruitment just prior to year-end.

A notable challenge during 2012-13 was the vacancy of the CLRN Research Nurse post for

a full calendar quarter. The lack of regular data support remained an ongoing challenge, as

in prior years.

Collaborative work between WH and RFH continued due to consultants oncologists and

surgeons working across both sites. The NLCRN provided Lead Nurse and QA support and

also a CTP based at WH.

Breast28%

Colorectal26%

Haematological7%

Lung14%

Prostate23%

Psychosocial2%

Figure 5G: The Whittington Hospital NHS Trust recruitment ofparticipants for 2012/13 by CSG



Table 5G: Patient Referral from WH to other NLCRN Trusts 2012-13



Whittington HospitalNHS Trust

University College LondonNHS Foundation Trust

6 BRIGHTLIGHT, CONVERT

TOTAL 6

Focus for 2013-14

One focus over the coming year is to expand the portfolio of active studies and increase

recruitment. WH has expressed interest in opening commercial trials and NIHR industry-

adopted trials. Since the closure of ATTRACT-2 in Autumn 2010, there has been no

commercial trials activity and so this area is ripe for expansion. Recruitment to the UK-GPC

Study is expected to rise significantly due to a recent substantial amendment which enables

patients to be approached and consented in clinic, rather than being referred. WH also

hopes to open a few new studies over the next coming year.



Follow Up

Follow up data is not routinely monitored by the network office as it does not directly relate to

the opening of new studies. In instances when a backlog has occurred the research network

was able to allocate some central data management resources. The research teams at the

respective sites are able to provide an overview which is summarised in the Appendix 3.

The NLCRN uses the NCRN Patient Status Definitions Group for follow up type 2: study data

is collected by any member of staff designated in the site file study responsibility log. Study

data collection does not include clinical investigations as described in type 1 follow-up.

UCLH have the highest level of follow-up activity (857 patients) compared to the other sites

which is predominantly due to the size of its portfolio, GOSH comes in second with 642

patients in follow-up, mainly due to leukaemia studies and high survival rates in this group of

patients. Barnet and Chase Farm and Princess Alexandra sites had the lowest number of

patients in follow-up, again due to the portfolio size, 111 and 115 consecutively (see

Appendix 3).

Non-Portfolio Activity

The NLCRN has additional activity in commercial and local academic studies across the

network’s Trusts. This information is captured using the trial management database EDGE,

which recently migrated to a new version resulting in a slight lag in recording data for new

local academic studies.

The recruitment of active commercial studies has remained stable in 2012-13, recruiting 102

patients. Due to the drive to ensure that locally developed studies are adopted on to the

NIHR portfolio, the activity in this part of the portfolio has not significantly increased. Tumour

groups with improved commercial activity include haematology, gynaecology and genetic

studies, with recruitment across multiple sites.

The Quality Assurance Manager and the Governance Manager send out frequent reminders

to the site staff to update patient data on EDGE version 2, ensuring that the full activity of

research teams is captured.

Workforce


Section 3: Workforce

Infrastructure

The Centralised TeamThe NLCRN supports a mixed model of staff appointments with a core centralised team and

a wider devolved team at the different hospitals. The new RNM/Lead Nurse started in

September to work alongside the part-time RNM and by being full-time, has been able to

provide additional crucial day-to-day operational management. Currently this post leads on

workforce development for the network and is part of the Pan-London Training Group.

One of the strengths of the centralised team is excellent team working and the ability to

absorb and cover vacancies whilst still being able to provide an excellent operational

service. This has been of particular benefit during this period when we have had a

considerable number of vacancies due to staff turn-over. Of note, the Senior Clinical Trials

Administrator left her post

during the year and so it

became crucial to cover this

post to minimise the effect

on the wider network, the

set-up of studies and

ultimately the delivery of

clinical trials. One of the

newly appointed Data

Managers has been

successfully covering this

role. The centralised team

and its far reaching remit are

crucial to the success of the

wider network, both

operationally and

strategically. Our centralised

trial set-up facilitates and encourages interaction with the wider network and provides day-to-

day contact with Trusts and R&D Departments. With the centrally managed Data Managers

and Clinical Trial Practitioners spending half a day a week in our central office, they have

office projects such as supporting study set-up and audits, which gives a better

understanding of the clinical trials processes and also serves as professional development.

The Senior RNM post provides oversight and strategic leadership for the Network as well as

supporting the local ECMC functions and providing management for the Cancer Clinical

Trials Unit at UCLH. The QA Manager has responsibility to maintain SOP’s and undertake

audits across all sites whilst the Industry Manager supports the NIHR commercial trials

across the network. The job-share RNM works with all sites which results in good

communication and allows us to effectively performance manage sites.

Workforce


Figure 6: Centralised NLCRN Team Organogram

All research staff across trusts that are managed locally at site, irrespective of funding

source work on both NIHR and non-NIHR trials. They are managed within their Trusts by

either a research manager or team leader or by a senior research nurse. Where they are the

sole members of staff or work within a very small team they are managed by the Lead Nurse

for cancer.

Dr John Bridgewater

NLCRN Clinical Lead (0.1WTE)

Dr James Lyddiard

Senior Research Network

Manager (0.3WTE)

Aderonke Adebiyi

NLCRN & UCL ECMC Manager

(1.0WTE) NLCRN funded

Christine Menzies

Network Industry Manager

(0.4WTE) RCF funded

Vacant Senior

Administrator & Research

Governance Manager

(1.0WTE) ECMC funded

Emma Douch

Clinical Trials Assistant

(1.0WTE) NLCRN funded

Guy Schroeter

QA Manager (1.0WTE)

NLCRN funded

3 x Clinical

Trials

Practitioners

Azmina Verjee

(WH) (0.8WTE)

NLCRN funded;

Vacant (BCF)

(1.0wte); Vacant

3 X Clinical

Data Managers

Gayle D’Souza

(1.0WTE), Gita

Parmar

(1.0WTE),

Vacant

(1.0WTE) NLCRN

funded - RCF

Masuma Harrison

NLCRN Manager (0.5WTE)

NLCRN funded

Workforce


Table 6: Whole Time Equivalents across the Whole Research Network

Trust Totalresearchresource

Nature of posts Numberof posts

NLCRNcomponent oftotal resource

(inc RCF)UCLHOncology

28.8WTE 1.0 WTE Research Managers3.0 WTE Team Leaders14.8 WTE Research Nurses2.0 WTE Clinical TrialsPractitioners0.4 WTE Radiographer5.6 WTE Data Managers2.0 WTE Administrator

31 1.9 WTE

UCLHHaematology

10.8WTE 1.1 WTE Research Managers2.7 WTE Research Nurses3.0 WTE Clinical TrialsPractitioners3.0 WTE Data Managers1.0 WTE Administrator

12 1.0 WTE

UCLHOther

4.8WTE 0.7 WTE Head of Trials0.9 WTE CR UK Lead Nurse3.2 WTE BRIGHTLIGHT &BCRT POPP & other

6 0

UCLHCRF

17.1 WTE 1.0 WTE Lead Research Nurse1.0 WTE Clinical PortfolioManager7.6 WTE Research Nurses0.5 WTE Clinical TrialsCoordinator5.0 WTE Data Managers0.5 WTE Lab Manager0.5 WTE Lab Technician1.0 WTE Administrator

19 0

RFH 24.6 WTE 1.0 WTE Lead Nurse1.0 WTE Clinical PortfolioManager11.6 WTE Research Nurses6.0 WTE Clinical TrialsPractitioners3.0 WTE Data Managers2.0 Admin & Technical

25 1.9 WTE

GOSH 7.5 WTE 1.0 WTE Lead Nurse0.5 WTE Research Associate2.0 WTE Research Nurse3.0 WTE Data Managers1.0 WTE Administrator

8 0.6 WTE

WH 2.05 WTE 1.0 WTE Research Nurse0.25 WTE DataManager/Administrator

3 0

BCF 1.8 WTE 0.8 WTE Clinical Trials 2 1.0WTE

Workforce


Practitioner1.0 WTE Data Manager

NMH 6.09 WTE 4.22 WTE Research Nurses0.5 WTE Data Manager1.37 WTE Administrator

8 0.5WTE

PAHHarlow

1.84 WTE 0.54 WTE Research Nurse0.8 WTE Clinical TrialsPractitioner/Administrator0.5 WTE Data Manager

3 1.84 WTE

PAHEpping

2.5 WTE 2.5 WTE Research Nurses 4 0

Centralisedstaff

11.1 WTE 0.3 WTE Senior ResearchManager1.0 WTE Research Manager0.5 WTE Lead Nurse0.4 WTE Industry Manager1.0 WTE QA Manager2.9 WTE Clinical TrialsPractitioners3.0 WTE Data Managers1.0 WTE Senior Admin & RGM1.0 WTE Administrator

11 10.1WTE

Total 118.98WTE 18.84 WTE

Workforce development

We remain a part of the South East Region Workforce Development Group.

Aderonke Adebiyi has acted as the nominated representative of the South East Region

Training and Education (T&E) Group for the NLCRN and is responsible for the dissemination

of education events held across NLCRN. GCP training is held 3-4 times a year by an

external facilitator. Aderonke Adebiyi has undertaken the NIHR GCP Facilitator training and

aims to support GCP training within the network in the future. The NLCRN hold quarterly

research forums to which all research staff working on cancer clinical trials throughout the

network are invited. The forums include presentations from staff at individual trusts on their

varied portfolio’s and speakers of wider general interest. The forum is also used as a way to

update all staff on local/national measures and also offers opportunities to network and forge

relationships. In addition the RNM meets with sites at bi-monthly meetings (particularly the

smaller trusts) to encourage staff look at recruitment figures and trouble shoot where

necessary.

Workforce


Additional Local Workforce Initiatives

We held a centralised team away day in November 2012 It was positively

received by all the staff and felt to be of great value to a team that do not necessarily

work together on a day–to-day basis, developing team building and problem solving.

We have also continued with our team staff meetings, Research Forums and

Induction sessions throughout the year which have proved to be a great success.

Further to the creation of a network quality assurance forum by our QA manager, we

were able to hold a half day SOP training session in November hosted by

the NLCRN to increase knowledge and importance of SOP’s, discuss QA issues in

greater depth and learn more about QA principles and methods. There are also

plans to audit the SOP’s across the network focusing on specific trials.

Half-day Good Clinical Practice (GCP) refresher courses are run in-house with

an external trainer three or four times a year. The primary reason these are held

internally is to provide ease of location and a convenient time for both our clinicians

and network staff. Other local GCP courses are available to staff predominantly

provided by the Joint R&D Office.

The E-Learning Module was successfully introduced at UCLH in 2011 to

increase the awareness of clinicians about SOPs and complete competency

assessments on specific SOPs. There has been a positive response and compliance

has greatly improved with 60% of PIs completing the module. From April 2013, the

team will only approve new trials through the TFC if the PI has completed the SOP

training.

Conferences were well attended this year. The network was able to fund (or

part fund) places for network staff at ASCO and the NCRI Conference with feedback

being given to the wider network at the research forums.

Patient and Public Involvement (PPI)


Section 4: Patient and Public Involvement (PPI)

Patient and public involvement (PPI) is integral to the

function of the NLCRN. We have 2 PPI representatives

who attend the NLCRN Steering Committee and provide

in-sight from a non-professional perspective. Andrew

Poulter who has been one of our Steering Committee

Groups Representatives since initiation decided to step-

down in 2012/13. We would like to thank Andrew for his

important contribution over the years.

The NCLRN additionally held a cancer research public

open day on Saturday 28th April 2012, the aim of which

was to help raise awareness of cancer clinical trials and

the exciting new research initiatives associated with the

outcome of these trials, showcasing both early and late

phase research at UCL/UCLH. As well as being a day

aimed at patients and the public in the local area, patients

were heavily involved in the planning of the day. A

planning group was created between the NLCRN, UCL

ECMC and a few consumers, who were also recruited to

this group, two from the research network and three from

the ECMC. The consumer representatives provided

invaluable advice on the structure and content of the day.

The day started by exploring the world of cancer research

at UCL, learning about how advances in understanding

cancer genetics are improving the outcomes for patients

with cancer, the role of gene therapy in fighting cancer,

and how advances in imaging are helping to improve

cancer treatments. Lastly, talks were given from patients’

perspective by hearing about a patient’s experience in

participating in a trial. The attendees were able to

participate in demonstrations at the venue of their choice

(The UCLH Macmillan Cancer Centre, the UCL Cancer

Institute and the UCLH Clinical Research Facility). The

demonstrations included the opportunity to visit the first

PET MRI scanner in the UK and hear a discussion on its

involvement in novel research projects, extraction of DNA

from strawberries and taking part in practical

demonstrations of sample collection and centrifugation in

the CRF. With a great number of attendees, the feedback

received was extremely positive both on the day and via

evaluation forms.



Feedback from the PPI open day was gained from a comprehensive questionnaire

completed at the end of the day. Attendees were asked to rate each guest speaker along

with the afternoon demonstrations for interest as well as giving general feedback on aspects

such as the catering, venue and length of day. The overwhelming majority of feedback was

positive, with 98% of those who attended saying they would recommend the open day to

others and 95% agreeing that the day met their expectations. The afternoon demonstrations

proved very popular, especially within the new UCLH Macmillan Cancer Centre where over

95% strongly agreed that they found the session interesting.



Social Media and PPI: The NLCRN Twitter FeedSocial media refers to the means of interactions among people in which they create,

share, and exchange information and ideas in virtual communities and networks. A

NLCRN twitter account was set up on 22nd of March 2012 to facilitate communication with

regards to the PPI Strategy, as well as a platform to raise awareness of network events and

projects. This has been a huge success and our followers are rising every day. We received

a lot of publicity by being re-tweeted and being mentioned in other feeds. The QA Manager

is working to use this platform to increase public awareness of cancer clinical trials in the

North London area as well as enhance the social media profile of the NLCRN, reaching parts

of our network that we previously had not. Considering that, some of the tweets are related

to new finding in oncology but in a non-technical vocabulary.

You can follow us at http://www.twitter.com/NLCRN or @NLCRN.

Other Initiatives


Section 5: Other Initiatives

One of the main initiatives within our network this year has been working more

closely with NEL and the CEL CLRN in preparation for the LCRN pilot which is due

to start in April 2013. This has involved a series of meetings including the clinical

leads and management teams from North and North East London and the CEL

CLRN. The pilot is aimed at informing the transition process due to start in April

2014 in addition to building on the relationship with UCL Partners and London

Cancer.

Following on from this we have been working collaboratively with NEL to provide

localised trial maps and detailed activity reports to all disease specific pathway

boards on clinical trials recruitment across London Cancer, this will be useful in

ensuring portfolio balance and delivery.

The UCLP Harmonisation Project pilot for commercial research, managed by the

CELCLRN is something that we also have been heavily involved in the delivery of.

Two out of the three Hubs for this pilot are situated in the NLCRN network. The pilot

was rolled out across UCLP in October 2012 and was aimed at providing a

streamlined approach to obtaining NHS permission for commercial trials.

Internal auditing of specific trials across the trusts within the network was carried out

during 2012-13. This was aimed at ensuring that quality and standard measures

were met. The feedback from the various sites across the network regarding this

exercise was very positive and plans are being put in place to extend this further.

In January 2013 The NLCRN migrated from EDGE version 1.3 over to EDGE

version 2 and one of our priorities here has been to ensure all staff across the

network are trained in the use of EDGE version 2, evaluate their use of the database

and encourage more comprehensive data collection. We plan to work with North

East London in order to cohesively use information on EDGE for use within the

LCRN Pilot and across London Cancer. Continual monitoring of NIHR and EDGE

database accrual discrepancies takes place every 3 months.

The IM put together a newsletter for lymphoma commercial trials as this was an area

where a greater number of open commercial trials were under performing compared

to other areas. The newsletter listed sites that were performing well within NLCRN,

all the open commercial lymphoma trials within the NLCRN, including the main

inclusion and exclusion criteria and the contact details of the PIs and research

nurses.

A NLCRN twitter account was set up on the 22nd of March 2012 to facilitate

communication with regards to the PPI Strategy, as well as a platform to raise

awareness of network events and projects. This alongside the successful PPI open

day has underlined the Network’s PPI Strategy.

Future Plans


Future Plans

Looking forward to 2013-14, the network plans to circulate a regular newsletter

listing trials that are open within both NEL and NL CRN together with a Quality

Assurance section. The hope is that this newsletter will lead to an increase in

awareness of specific studies and therefore referrals across the network to help

ensure all the trials meet their target within the recruitment window and highlight the

importance of quality issues, e.g. SOP’S, audits etc.

The network hopes to improve on its recruitment as discussed in the trust by trust

‘Focus for 2013-14’ sections (Section 2: Portfolio and Recruitment). Recruitment to

RCT’S was down this year so we hope to work in collaboration with NEL to improve

recruitment particularly in the rarer tumour groups over the coming year.

Attendance at each of the UCLP Cancer Pathway Boards by a member from either

the North or North East London. The Cancer Research Network management team

will ensure that research is given a high priority on each of the pathway boards.

We will be working with North East London and the CEL CLRN in the LCRN pilot in

2013/14. One of the areas we will be focusing on within the pilot is a centralised

model for opening all new studies and processing protocol amendments across both

networks.

In preparation for the transition we will be working with and supporting the CEL

Transition Management Team to help identify any issues /achievements that can be

taken forward to inform the transition in 2014.

We will be running Induction days for new staff within the network every 3 months.

This comprises of an overview of the Network by the Network Manager followed by

Training on EDGE and SOP Training conducted by the Network’s QA Manager.

The QA Manager plans to start running more structured EDGE Training in a

computer room to help sites to understand and practice in real-time. This will

encourage the collection of accurate data by sites and therefore enable the Network

to run monthly reports which can then be used in performance management of the

portfolio.

We would like to expand on the current research forums by taking it a step further

and holding a day consisting of talks and opportunities for networking for all the

Research Nurses, Clinical Trials Practitioners, Data Managers and administration

staff across North and North East London. Research forums in Quality Assurance

might also be developed.

We aim to carry out Internal GCP audits across Trusts within the network in 2013-

14. This will consist of a comprehensive audit programme covering Investigator and

Pharmacy Site Files, source data and Case Report Forms, SOPs and EDGE

Future Plans


Follow us on Twitter @NLCRN!

completion. We hope to start these audits in July 2013 to improve and maintain

quality standards in our research.

Twitter activity will also be updated weekly with the latest cancer research news.

Appendices


Appendices

Appendix 1: NLCRN Portfolio Activity

Table 7: Portfolio and Recruitment for 2012-13 (compared against forecast recruitment)

Primary CSG Study Acronym / Short Title Active Status Randomisation Study Design RecruitmentForecast

RecruitmentAnaesthesia, IntensiveCare and Cardiology

MCRN035 (BUP1501) Closed - in follow-up Non-randomised

Interventional 3

Bladder Cancer Group BOXIT Closed - in follow-up Randomised Interventional 2

Bladder Cancer Group POUT Open Randomised Interventional 2

Bladder Cancer Group TOUCAN (Bladder cancer) Open Randomised Interventional 2

Bladder Cancer Group BOLERO Closed - in follow-up Randomised Interventional 7 8

Bladder Cancer Group HYMN Open Randomised Interventional 5 5

Brain Tumour Group NBT Open Non-randomised

Observational 20

Brain Tumour Group DORIC - Phase II trial of cediranib +/-gefitinib for recurrent glioblastoma

Closed - in follow-up Randomised Interventional 3 15

Brain Tumour Group Feasibility of 5-ALA and Carmustinewafers for Glioblastoma (GALA-5)

Open Non-randomised

Interventional 2 5

Brain Tumour Group EORTC 26091 (TAVAREC) Open Randomised Interventional 3 5

Brain Tumour Group Phase I trial of IMA950 multipeptidevaccine plus GMCSF in glioblastoma

Closed - in follow-up Non-randomised

Interventional 6 10

Brain Tumour Group BR14 (EORTC 26053-22054) Open Randomised Interventional 4 5

Key

Recruited at least 90% of forecast

Recruited to 66-89% of forecast

Recruited less than 65% of forecast

Appendices



RecruitmentBreast Cancer Group Abiraterone Acetate in Advanced or

Metastatic Breast CancerOpen Non-

randomisedInterventional 8

Breast Cancer Group Chemo-NEAR Open Non-randomised

Observational 2

Breast Cancer Group Endo-NEAR Open Non-randomised

Observational 2

Breast Cancer Group FAST-Forward Open Randomised Interventional 20

Breast Cancer Group SOLD Open Randomised Interventional 3

Breast Cancer Group SUPREMO Closed - in follow-up Randomised Interventional 3

Breast Cancer Group TNT Open Randomised Interventional 5

Breast Cancer Group EPHOS-B Open Randomised Interventional 1 5

Breast Cancer Group TARGIT Closed - in follow-up Randomised Interventional 8 30

Breast Cancer Group NeoExcel Open Randomised Interventional 5 6

Breast Cancer Group REACT- Randomised EuropeanCelecoxib Trial


Breast Cancer Group SEARCH Open Non-randomised

Observational 104 120

Breast Cancer Group PARP BRCA trial Open Non-randomised

Interventional 3 3

Breast Cancer Group ARTemis Closed - in follow-up Randomised Interventional 16 15

Breast Cancer Group Persephone Open Randomised Interventional 23 20

Breast Cancer Group POETIC Open Randomised Interventional 13 10

Breast Cancer Group BOCS (formerly FBCS) Open Non-randomised


Breast Cancer Group ICICLE Open Non-randomised

Observational 4 2

Breast Cancer Group IMPORT HIGH Open Randomised Interventional 36 15

Breast Cancer Group AFFECT Open Non-randomised

Observational 4

Breast Cancer Group COPE Open Non- Observational 1

Appendices



Recruitmentrandomised

Breast Cancer Group OPTIMA Open Randomised Interventional 4

Children's Cancer andLeukaemia

CNS 2004 10 (Functional Imaging ofTumours)

Open Non-randomised

Observational 1


EPOC Doxorubicin in children Closed - in follow-up Non-randomised

Both 3


PK 2006 07 (ActD in children) Closed - in follow-up Non-randomised

Observational 2


PK 2006 09 (Infant PK) Closed - in follow-up Non-randomised

Observational 1


CNS 2004 03 (LOW GRADE GLIOMA2 SIOP-LGG2 2003)



FACT study Open Non-randomised

Observational 9 20


ET 2000 03 (EURO-E.W.I.N.G. 99) Open Randomised Interventional 10 10


UKALL 2011 Open Randomised Interventional 20 20


NB 2002 06 (High RiskNeuroblastoma)

Open Randomised Interventional 9 5


LK 2006 10 (Interfant 06) Open Randomised Interventional 2 1


LT 2007 03 (SIOPEL 6) Open Randomised Interventional 3 1


CNS 2004 10 (Functional Imaging ofTumours)

Open Non-randomised

Observational 87


EuroNet PHL-LP1 Hodgkin's Open Non-randomised

Both 2


GD2: Long term continuous infusionch14.18/CHO plus s.c. aldesleukin (IL-

2)

Open Non-randomised

Interventional 3


Improving Population Outcomes forRenal Tumours of Childhood

(IMPORT)

Open Non-randomised

Observational 8

Appendices



RecruitmentColorectal Cancer

GroupFollow up to MOSAIC study Closed - follow-up

completeNon-

randomisedObservational 20

Colorectal CancerGroup

Predisposition to serrated neoplasiaand tumours (PRESENT) study

Open Non-randomised

Observational 5


FOxTROT Open Randomised Interventional 2 10


Aristotle Open Randomised Interventional 2 5


New EPOC Closed - in follow-up Randomised Interventional 4 10


NSCCG Open Non-randomised

Observational 21 45


EPOC B Open Randomised Interventional 3 6


FOXFIRE Open Randomised Interventional 1 2


Pulmonary Metastasectomy inColorectal Cancer (PulMICC)



ROLARR (RObotic versusLAparoscopic Resection for Rectal

cancer)



SCOT Open Randomised Both 55 25


Tumour Angiogenesis Open Non-randomised



CORGI Open Non-randomised

Observational 59 11

Genetics EMBRACE Open Non-randomised

Observational 56

Gynaecological CancerGroup

A Phase II Clinical Trial in Patients withBRCA defective Tumours (6MP)

Open Non-randomised

Interventional 4


CIRCCa Closed - in follow-up Randomised Interventional 4


DESKTOP III Open Randomised Interventional 3

Appendices



RecruitmentGynaecological Cancer

GroupPARAGON Open Non-

randomisedInterventional 2


SaPPrOC Closed - in follow-up Randomised Interventional 5


INTERLACE Open Randomised Interventional 3 10


PORTEC3 Open Randomised Interventional 2 5


mEOC Open Randomised Interventional 1 2


PETROC/OV21 Open Randomised Interventional 3 5


ICON8: Weekly Chemotherapy inOvarian Cancer



GROINSS-V II Open Non-randomised

Observational 8 3


ICBP MODULE 4: Root causes ofdiagnosis and treatment delay in

cancer

Open Non-randomised

Observational 1

HaematologicalOncology Group

CLL210 (CamDexRev) Suspended Both Interventional 4


COSMIC Version 2.0 Open Randomised Interventional 2


EsPhALL Open Randomised Interventional 1


InCiTE - Intracranial haemorrhage inthrombocytopenic haematology

patients

Open Non-randomised

Observational 1


LenaRIC Open Non-randomised

Interventional 6


MYELOMA XI Open Randomised Interventional 6


RIAltO Open Randomised Interventional 3


RIC UCBT Open Non-randomised

Interventional 3

Appendices



RecruitmentHaematologicalOncology Group

REVEAL Open Randomised Interventional 1 10


AML 16 Closed - in follow-up Randomised Interventional 1 6


PT1 Closed - in follow-up Randomised Both 1 4


SPIRIT 2 Closed - in follow-up Randomised Interventional 2 5


TEAMM: Tackling early morbidity andmortality in myeloma



MAC UCBT Open Non-randomised

Interventional 1 2


MUK one Closed - in follow-up Randomised Interventional 1 2


MUK three Open Non-randomised

Interventional 3 6


WT1 TCR-001 Open Non-randomised

Interventional 1 2


LI-1 Open Randomised Interventional 4 6


AML 17 Open Randomised Interventional 24 30


Bortezomib Consolidation Trial Open Non-randomised

Interventional 15 15


EBV associated NK/T cellmalignancies

Open Non-randomised

Observational 1 1


MARALL Open Non-randomised

Interventional 2 2


Myeloma X Relapse (Intensive) Closed - in follow-up Randomised Interventional 2 2


UKALL 14 Open Randomised Interventional 12 10


AML 18 Pilot Open Non-randomised

Both 6 4


PADIMAC Open Non-randomised


Appendices



RecruitmentHaematologicalOncology Group

ALLR3 Open Non-randomised

Interventional 4 2


CMV-ACE/ASPECT Open Randomised Both 5 2


LenD (Lenalidomide in CLL) Open Non-randomised

Interventional 5


MUK five Open Randomised Interventional 3

Head and Neck CancerGroup

ART DECO Open Randomised Interventional 3


De-ESCALaTE HPV Open Both Interventional 5


Head and Neck Cancer: molecular,cellular and immunological

mechanisms

Open Non-randomised

Observational 10


SEND Open Randomised Interventional 2 5


TITAN Open Randomised Interventional 2 5


COSTAR Closed - in follow-up Randomised Interventional 1 2


HeadandNeck5000 Open Non-randomised

Observational 11 15


The LEONIDAS2 study Open Randomised Interventional 27 20


PET-NECK study Closed - in follow-up Randomised Interventional 2 1

Immunology andInflammation

A phase III randomised study toinvestigate the use of adoptive cellular

therapy (ACT)

Open Randomised Interventional 5

Lung Cancer Group CONVERT Open Randomised Interventional 2

Lung Cancer Group STOMP In Set-Up PendingNHS Permission

Randomised Both 1

Lung Cancer Group TIMELY Open Non-randomised

Interventional 1

Appendices



RecruitmentLung Cancer Group REST - Chest Irradiation in Extensive

Disease Small Cell Lung CancerClosed - in follow-up Randomised Interventional 1 5

Lung Cancer Group ET Trial Open Randomised Interventional 15 25

Lung Cancer Group MALCS (Mesothelioma and LungCancer Study)

Open Non-randomised

Observational 11 10

Lung Cancer Group Streamline L Open Non-randomised

Interventional 3

Lymphoma Group AITL Closed - in follow-up Non-randomised

Interventional 1

Lymphoma Group Intestinal t-cell trial (ITCL) Open Non-randomised

Interventional 3

Lymphoma Group MiniAllo Open Non-randomised

Interventional 2

Lymphoma Group ReACH Closed - follow-upcomplete

Non-randomised

Interventional 2

Lymphoma Group IELSG32 Open Randomised Interventional 2 6

Lymphoma Group NSHLG - National Study of Hodgkin'sLymphoma Genetics

Open Non-randomised

Observational 28 60

Lymphoma Group EuroNet PHL-C1 Hodgkin's Closed - in follow-up Non-randomised


Lymphoma Group PACIFICO Open Randomised Interventional 4 5

Lymphoma Group R-CODOX-M/IVAC Closed - in follow-up Non-randomised

Interventional 5 5

Lymphoma Group MELT MRI Evaluation of LymphomaTreatment

Open Non-randomised

Observational 21 18

Lymphoma Group PAIRed Open Non-randomised

Interventional 6 5

Lymphoma Group REMoDLB Open Randomised Interventional 6 5

Lymphoma Group ProT4 (Prophylactic Transfer of CD4Lymphocytes)


Lymphoma Group RATHL Closed - in follow-up Randomised Interventional 10 3

Lymphoma Group PET after 2 cycles in NHL (sub-study) Closed - in follow-up Non-randomised

Interventional 3 0

Appendices



RecruitmentMelanoma Group NICAM Open Non-

randomisedObservational 2 3

Metabolic andEndocrine (not

diabetes)

AIP Open Non-randomised

Observational 22

Non-MalignantHaematology

Study of haematology in newbornswith Down syndrome

Open Non-randomised

Observational 8

Palliative & SupportiveCare Group

Depression and anxiety in prostatecancer

Closed - follow-upcomplete

Non-randomised

Observational 23

Pharmacy andPharmacology

MAGIC Closed - in follow-up Randomised Interventional 16

Prostate Cancer Group COMPARe study: COMparingtreatment options for ProstAte canceR

Open Non-randomised

Observational 3 10

Prostate Cancer Group RADICALS (MRC PR10) Open Randomised Interventional 9 10

Prostate Cancer Group UK Genetic Prostate Cancer Study Open Non-randomised

Observational 29 25

Prostate Cancer Group IMPACT Open Non-randomised

Observational 7 5

Prostate Cancer Group INDEX Open Non-randomised


Prostate Cancer Group STAMPEDE Open Randomised Interventional 23 10

Prostate Cancer Group PROMIS Prostate MRI Imaging Study(MRC PR11)

Open Non-randomised

Both 107 10

Psychosocial OncologyGroup

Biliary Tract Cancer QoL Validation Open Non-randomised

Observational 5 20

Psychosocial OncologyGroup

CanTalk V3 Open Randomised Interventional 4 5

Radiotherapy Group Anti-CD66 Open Randomised Interventional 7

Radiotherapy Group RAPPER Open Non-randomised

Observational 5 5

Renal European Trial of Free Light ChainRemoval by Extended Haemodialysis

in Cast Nephropathy

Open Randomised Interventional 5

Renal Cancer Group Surtime - EORTC 30073 Open Randomised Interventional 1 2

Appendices



RecruitmentRenal Cancer Group SORCE Closed - in follow-up Randomised Interventional 3 5

Renal Cancer Group TRANSORCE (sub-study of SORCE) Closed - follow-upcomplete

Randomised Interventional 15 12

Renal Cancer Group CARMENA Open Randomised Interventional 1

Respiratory Magnetic Resonance Imaging of LungNodules

Open Non-randomised

Observational 1

Sarcoma Group CASPS Open Randomised Interventional 2

Sarcoma Group OTIS Closed - in follow-up Non-randomised

Interventional 2

Sarcoma Group STRASS (EORTC 62092-22092) Open Randomised Interventional 2

Sarcoma Group VORTEX BIOBANK Open Non-randomised

Observational 10

Sarcoma Group VORTEX Open Randomised Interventional 7 10

Sarcoma Group STS 2006 04 RMS 2005 (ESSG1) Open Randomised Interventional 5 6

Sarcoma Group GeDDiS Open Randomised Interventional 14 15

Sarcoma Group Axi-STS Open Non-randomised

Interventional 5 5

Sarcoma Group STS 2006 03 (NRSTS) Open Non-randomised

Interventional 6 3

Testis Cancer Group 111 Trial (formerly BEP 111) Open Non-randomised

Interventional 2 2

Testis Cancer Group TRISST Open Randomised Interventional 6 5

The Teenage andYoung Adults ClinicalStudies Development

Group

BRIGHTLIGHT: The 2012 TYA CancerCohort Study

Open Non-randomised

Observational 21

Upper Gastro-IntestinalCancer Group

Barrett's Oesophagus Closed - in follow-up Non-randomised

Observational 3


ESPAC -Tplus Closed - follow-upcomplete

Non-randomised

Observational 3


ABC-03 Closed - in follow-up Randomised Interventional 5 15

Appendices



RecruitmentUpper Gastro-Intestinal

Cancer GroupViP Open Randomised Interventional 1 3


ST03 Open Randomised Interventional 2 5


LEO (Lapatinib in Early Oesophago-gastric Cancer)

Open Non-randomised

Both 3 5


Immune responses in HepatocellularCancer v1.0

Open Non-randomised

Observational 29 40


TACE-2 Open Randomised Interventional 9 10


BILCAP Open Randomised Interventional 6 5


ESPAC-4 Open Randomised Interventional 9 6


PET-PANC Closed - in follow-up Non-randomised



BOOST Open Non-randomised



CUP ONE Open Non-randomised



ABC-04 Closed - in follow-up Non-randomised

Interventional 6 2


Evaluation of a NonEndoscopic Devicefor Barrett's Oesophagus - BEST 2

Open Non-randomised

Interventional 126


OCCAMS - Evaluation of revisedstaging system for GOJ

adenocarcinoma

Open Non-randomised

Observational 9


TRANSBIL (Biliary MCM5 Study) Open Non-randomised

Observational 59

Appendices


Appendix 2: Delivery of NIHR Clinical Research Network adopted Commercial Studies

Table 8A: Commercial studies which closed to recruitment nationally during the 2012-13 reporting year

KeyRecruited at least 90% of forecastRecruited to 66-89% of forecastRecruited less than 65% of forecastSlashed green if recruitment is 15% behind timeMissing information &/or there is not enough information yet to calculate the % timeStudy has not reported any recruitment data

Clinical StudiesGroup NCRN Ref No.

Agreed target(RAG report)(Number by

date)

Actual Number ofpatients recruited

to dateComments

Breast NCRN052CEREBEL

4 by 22/03/2013 4

NCRN122BOLERO 3

3 by 17/05/2012 0 This study was initiated without Network involvement, feasibility of sitewas not realistic

NCRN260RESILIENCE

3 by 31/03/2013 4

Haematology NCRN132 KW-24784

2 by 28/09/2012 4

NCRN298 4 by 31/12/2012 5

Lymphoma NCRN435SPARK

2 by 29/03/2013 5

Colorectal NCRN388 3 by 30/06/2013 6

Upper GI NCRN214BAGPAC

3 by 31/12/2012 4

NCRN256 2 by 30/06/2012 1 The study was delayed in set-up due to the CRO and closed 6 monthsafter it was open to recruitment which restricted the opportunity torecruit to target

Children's Cancer &Leukaemia

NCRN244PETEY

1 by 01/12/2012 0 Delays in opening and the study closed early due to results of interimanalysis

Lung NCRN248ARCHERN.Midd

5 by 28/02/2013 9

Appendices


Clinical StudiesGroup NCRN Ref No.

Agreed target(RAG report)(Number by

date)

Actual Number ofpatients recruited

to dateComments

NCRN248ARCHER UCH

5 by 28/02/2013 1 This study had delays both in the R&D approval process due tocomplex costing negotiations with the CRO (Ca 3 months) approvalprocess and post approval in opening to recruitment (Ca 2.5 months).Additionally feasibility was over-optimistic for this patient group. A trialsummary was created and circulated across UCLP to encouragereferrals

NCRN317Diacchi

3 by 01/07/2015 0 Issues with IRMER approval from the CRO delayed set-up and issueswith IMP storage highlighted at the Initiation Visit further delayed theopening of the study at site. As the study also closed early thisadditionally impacted on performance

Renal NCRN281GOLD

3 by 30/08/2012 3

Gynaecological NCRN390TRINOVA 1

2 by 08/11/2012 2

Appendices


Table 8B: Commercial studies open to recruitment nationally during the 2012-13 reporting year

Clinical StudiesGroup NCRN Ref No. Agreed target (RAG report)

(Number by date)Actual Number of

patients recruited to dateComments

Lymphoma NCRN069ORCHARD

R.Free

2 by 15/11/2013 0 This site was added at the end of 2012 withoutinput from NLCRN. GSK were looking foradditional sites to help ensure the national targetwas met within the recruitment window. The IMhas met with the PI/RN and also representativesfrom the Sponsor to discuss the issues. A flyerhas been sent to all Trusts within NE & NL to tryand boost referral numbers

NCRN069ORCHARD

UCH

5 by 15/11/2013 12

NCRN178SABRINA

2 by 01/11/2013 0 This site was added without input from theNLCRN. The Sponsor has since closed this sitedue to zero recruitment. Should not really havebeen included in the figures for NLCRN

NCRN246GALLIUM PAH

6 by 30/03/2014 5

NCRN246GALLIUM

R.Free

6 by 30/03/2014 3

NCRN316 5 by 31/12/2013 5

NCRN394 RAY 2 by 30/04/2014 1

Haematology NCRN170BLAST

2 by 01/11/2013 1

NCRN269 2 by 31/12/2013 0 Patient acceptance of study is low (5 approachedand all did not wish to participate). A flyer hasbeen sent to referring hospitals to encouragefurther screening. IM liaising with Guy's to identifyapproach to improve recruitment

NCRN336 1 by 01/06/2013 8

NCRN357 3 by 28/07/2015 3

Appendices





NCRN371 1 by 28/10/2014 No recruitment yet nationallyNCRN421 2 by 31/12/2013 0 R&D approval obtained, delay in set-up of e-

prescribing system. Formal screening soon tostart and likely to meet target

NCRN431ENDEAVOR

R.Free

2 by 31/05/2014 2

NCRN431ENDEAVOR

UCH

TBCStill being set up at UCH (not going through UCL-P harmonisation)

Upper GI NCRN104 BIBF 16 by 15/07/2013 22

NCRN301 ADI-PEG 20

4 by 01/02/2014 4

NCRN292 4 by 01/11/2013 0 A 3 month delay in opening after other 2 UK sitesdue to delays in granting R&D permission forstudy and subsequent amendment

NCRN328carcinoidtumours

2 by 01/04/2014 4

NCRN379 2 by 31/04/2013 1

Colorectal NCRN380 3 by 09/01/2015 0 Rare patient group unlikely to see eligible patientin current timeframe

NCRN477 TBC 2 Black nationallyBreast NCRN186

ALTERNATIVE2 by 07/03/2016 0 Difficult to recruit to study, only 1 patient entered in

the UKNCRN250APHINITY

10 by 20/11/2013 6

NCRN354PERUSE

5 by 30/09/2013 1 Recruitment challenging as IMP (Pertuzimab) wasgranted EU approval in March 2013 & since Mayhas been listed on the National Cancer DrugsFund list of treatment

NCRN407BELLE 4

3 by 28/02/2014 2

Appendices





NCRN409BELLE 2

4 by 19/11/2014 1

NCRN463TDM1 R.Free

5 by 01/09/2014 2

NCRN463TDM1 PAH

5 by 01/09/2014 1

NCRN5214EVER UK

4 by 31/12/2013 4

Gynaecological NCRN190TRINOVA 2

4 by 01/08/2015 2

NCRN373 TBC Study opened for recruitment on 22/5/13, the 1stpatient consented

NCRN385 2 by 16/05/2014 5NCRN514 2 by 29/11/2013 Open to recruitment no patients screened yet. No

recruitment yet nationallyChildren's Cancerand Leukaemia

NCRN259HERBY GOSH

2 by 31/05/2014 0 Rare patient group. Screened 1 but they were noteligible

NCRN259HERBY UCH

2 by 31/05/2014 1Rare patient group

NCRN339 3 by 01/07/2013 2NCRN350 1 by 01/11/2014 0 Rare patient group. No eligible patients since

opening the studyLung NCRN285 LUX

Lung 83 by 31/10/2013 2

NCRN387 5 by 05/11/2014 1NCRN400 1 by 30/10/2013 0 Screened 37 patients so far, no BRAF +ve patient

identifiedHead and Neck NCRN291 4 by 01/11/2013 1 Delays in the set-up & the initiation, PI is

screening 2nd patientProstate NCRN322

TERRAIN4 by 31/08/2013 4

NCRN464 3 by 30/11/2013 0 1 patient in screening, expected to be entered bythe end of June 2013

Melanoma NCRN415MELABIS

5 by 30/05/2013 10

Appendices





NCRN423COMBI V

(BRAK+MEK)

5 by 29/06/2013 5

NCRN427COMBI-AD

5 by 27/05/2014 1 Patient screening on-going

Appendices


Appendix 3: Follow-up

Table 9: Patient Follow-up Numbers

Hospital Study Number ofpatients

University College London Hospital Leukaemia 21

Lymphoma 92

Myeloma 48

BMT 23

Head and Neck 16

Neurology 44

Breast 36

Lung 5

Sarcoma 314

GI 64

Gynae 73

GU 105

Uro-surgery 16

Royal Free Hospital Breast 157

GI 86

Lung 10

Renal 15

Melanoma 52

Urology 40

Neuro-Oncology 5

Surgical 14

Leukaemia 48

Myeloma 12

BMT 6

Lymphoma 18

North Middlesex Hospital Breast 112

Urology 32

Head & Neck 1

Whittington Hospital Breast 150

Lung 86

Colorectal 55

Prostate 7

Cross-cutting 9

Haematology 1

Great Ormond Street Hospital Leukaemia 371

Lyphoma 8

Sarcoma 57

Urology 135

Appendices


Upper GI 10

Brain 12

Head & Neck 49

Barnet Chase Farm Hospitals Colorectal 2

Breast 36

Haematology 55

Urology 14

Lung 4

Princess Alexandra Hospital Colorectal 73

Upper-GI 6

Lung 1

Haematology 9

Urology 26

Total 2641

Appendices


Appendix 4: Executive Summary of Workforce Development Annual

Report for London & SE England

Key achievements and challenges of the Region during 2012-13

The Pan London & South East Workforce Development Regional Group continues to benefit

from the commitment and enthusiasm of its members; many of whom have put a

considerable amount time and effort into planning, developing and facilitating the courses.

The core cancer course programme of externally facilitated cancer courses ran successfully

this year.

Achievements within the group include, participation in the successfully concluded NCRN-

led Induction Handbook project by Heather Philipps, Helen Graham, Theresa Meehan and

Sean Chinnathumby. This is a very thorough and comprehensive resource for new recruits

to the cancer research network.

Also, of note is the NCRN/CLRN Training & Development Collaborative Course. This was &

is being led by Julia Simister (NCRN) and Emma Saunders (London South CLRN). It is a

joint initiative between Pan London & South East Workforce Development Regional Group

and South East CLRN training cluster. Several members of the Regional Group are Module

Champions namely; Helen Graham, Carrie Weller, Nicola Southwell with Gillian Ellis acting

as the overall Programme Coach.

The Regional Group continues to particularly value the various communications courses and

this is reflected in the regular provision of these courses, facilitated by several members of

the Regional Group, throughout the year, namely Linda Dawson- Athey, Sandra Burt, Helen

Graham & Anne Haldeos. Finally, Susan Palmer’s efforts to manage the recruitment and

appointment of a new Regional Workforce Development Lead in July-September 2012

should be recognised. Credit also needs to go to Veronica Sinclair, the Pan London & South

East Workforce Development Administrator, who succeeded in keeping the planned training

programme on track throughout the three months that no Workforce Development Lead was

in post.

Key priorities and challenges for the region for 2013-2014

The key priorities for 2013-14 are:

• To plan a programme of courses within the budget available and to manage the payment

and reconciliation & reporting of expenditure.

• To implement and manage the core cancer, communication and other course programmes.

• To design, develop & pilot a Team Leader Training Course.

• To design, develop & pilot Informed Consent & Pharmacovigilance workshops.

• To manage the changes in workforce development that will come with the organisational

re-structuring from April 2014 to ensure a smooth transition and continuity in workforce

development provision.


North London Cancer Research Network

Room G25 UCL Cancer Institute | Paul O’Gorman

Building | 72 Huntley Street | London WC1E 6BT

Phone: 0207 679 0775

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