Upper GI Research and Clinical Trials Update

Bridget WorkmanResearch Manager NECRN N

21ST November 2012

The Past History Lesson

NCRNFunded by DH fully Local cancer Research networks integrated with service networks (2001)

“To benefit patients by improving the coordination ,integration ,quality ,inclusiveness and speed of cancer research”

“To double recruitment into trials”

Recruitment NECRN N 2001-2012

0

500

1000

1500

2000

2500

3000

3500

2001-2 2002-3 2003-4 2004-5 2005-6 2006-7 2007-8 2008-9 2009-10 2010-11 2011-12

Total number of patients recruited to RCTs

Total number of patients recruited to non-RCTs

Total number of other participants recruited to RCTs

Total number of other participants recruited to non-RCTs

Recruitment NECRN S 2001-2012

0200400600800

100012001400160018002000

Total number of other participants recruited to non-RCTsTotal number of other participants recruited to RCTs

Total number of patients recruited to non-RCTs

Total number of patients recruited to RCTs

Upper GI/OGRecruitment

NECRN N 2001-2012

Upper GI/OGRecruitment

NECRN S 2001-2012

Department of HealthDepartment of Health

NHS Trusts

Cancer Service

Networks

NCRN CC

Cancer Research Networks

NCRINCRI

2001

Department of HealthDepartment of Health

NHS Trusts

Cancer Service

Networks

NCRN CC

Cancer Research Networks

NCRINCRI

NIHRNIHR

NIHR CRN CCNIHR CRN CC

Other Topic CCs

Comp’sive Network

CC

CLRNsOther Topic

Networks

2012

The Present

NCRN Strategy – 4 key areas

NIHR – High level Objectives

1. Impact

• Highlighting the need to better demonstrate the advantages to patients and public of delivering cancer trials alongside NHS cancer services.

• Demonstrate and measure the impact of individual studies

2. Industry

• Highlights continued need to attract and retain pharmaceutical industry investment. Requires expansion of industry trial portfolio and targets have been set for this.

• Minimum of 50 industry studies by 2011• Minimum of 75 industry studies by 2014• Requirement to deliver industry studies to

time and target.

3. Network Performance

• Continued success of Cancer Research Networks will be assured by proactive performance management process

• Increased research participation links to NHS Operating Framework, NCRI Strategic Plan and Improving Outcomes a strategy for Cancer (2011) to improve patient outcomes and enhancing delivery .

4. Portfolio Balance & Delivery

• Ensure NIHR portfolio reflects contemporary developments in stratified medicine as well as NCRI priorities in surgery, radiotherapy and non-drug trials.

• Extend portfolio to studies designed to prevent and diagnose cancer at earlier stage

• Studies opening and recruiting to agreed targets and timelines

• Continue to strengthen international links EORTC (Europe) NCI ( US)

2012-2013

Trial Description Open to Recruitment

A feasibility trial of chemoradiation or surgery for oesophageal cancer - Chemrad vs surgery

Oesophageal squamous cell cancer: induction chemotherapy and oesophagectomy versus induction chemotherapy and chemoradiotherapy - a feasibility study

Newcastle

Evaluation of a nonendoscopic device for Barrett's Oesophagus - Best 2

Evaluation of a non-endoscopic immunocytological device (cytosponge) for barrett's oesophagus screening in a case-control study (Best2)

Newcastle

ChOPIN Chemoprevention of premalignant intestinal neoplasia (ChOPIN) incorporating inherited predisposition of neoplasia (IPOD) analysis of genomic DNA from AspECT and BOSS clinical trials. It also incorporates patients undergoing genomic assessment independent of the AspECT and BOSS trials.

Middlesbrough Bishop Auckland Durham North Cumbria Wansbeck South Tyneside Sunderland

Minimally invasive Oesophageal Adenocarcinoma sentinel node biopsy 4.0

A prospective , observational study evaluating a minimally invasive technique of identifying the sentinel lymph nodes in patients undergoing surgery for oesophageal adenocarcinoma

Newcastle

ST03 A Randomised Phase III trial of Peri-operative Chemotherapy with or without Bevacizumab in Operable Adenocarcinoma of the Stomach and Gastro-oesophageal Junction

Newcastle Middlesbrough North Cumbria

The Future

• Governance Review for Research • New Structure Research 2014

– 14-18 Geographically based Clinical Research Networks

– Greater integration across different Topics Specialties – Single Host Organisation

• So now in period of Transition• Other considerations

– Clinical Service Network – Academic Science Networks

What does this mean ?

• Business as Usual • Balanced OG portfolio

– Opening to time and target – Recruiting to Time and target – Including Industry Trials

• Equity of Access - referral pathways – Handbooks and Portfolio Maps for NSSGS’s and MDT’s

Thank You