collaboration for oncology data in europe (code)...copyright © 2018 iqvia, all rights reserved....

Copyright © 2018 IQVIA, All Rights Reserved. Confidential and Proprietary.

Collaboration for Oncology Data

in Europe (CODE)

Launch Event Belgium

4th December 2018

Hotel Tangla, Brussels


This powerpoint presentation was presented at the Collaboration for

Oncology Data in Europe (CODE) Launch in collaboration with S.I.O. on

4th December 2018.

The presentations are confidential and not to be shared outside the S.I.O

organization.

Copyright © 2018 IQVIA, All Rights Reserved. Confidential and Proprietary.Copyright © 2018 IQVIA, All Rights Reserved. Confidential and Proprietary.

“A New Era of Quality Cancer Care”

The Film on “A New Era of Quality Cancer Care” was officially released during the ECCO Summit on 7th September in Vienna

Participants:

• Prof David Kerr (Professor of Cancer Medicine, University of Oxford and CODE CASC Chair)

• Prof Marc Peeters (Professor of Oncology, Antwerp University and CODE CASC Member)

• Patrick Crombez (Head Nurse, Institut Jules Bordet, EONS Board Member)

• Pete Wheatstone (Use MY data representative and Patient Representative for CODE)

• Ashley Woolmore (CODE Initiative Lead)


“A New Era of Quality Cancer Care”

https://www.ecco-org.eu/Global/News/Latest-News/2018/06/NEWS-ECCO-and-ITN


“Introduction of the CODE program Speakers”

Mrs. Myriam Guiral

Country Lead CODE

Belgium & The Netherlands


“CODE and the Oncology data network”

Dr. Ashley Woolmore, Senior VP, Head of European Data and Evidence Networks (EDEN), CODE Lead at IQVIA

“HCP participation joining the Oncology Data Network”

Mrs. Mirella Koenjer – Program manager oncology at Gelre Ziekenhuizen

“The benefits of a collaboration between S.I.O and CODE”

Mr. Patrick Crombez, Department Head Hematology at Institute Jules Bordet

“The advantages of a collaboration between the CODE initiative and the CAPRI project”

Mrs. Malou Kuppen, Institute of Health Policy & Management

“CODE Healthcare Analytics Demo”

Dr. Shivam Natarajam, Medical Oncologist and Product Advisor CODE

“Questions & Answering: Panel discussion”

Panel Moderator: Mrs. Myriam Guiral

Panel Members:

▪ Dr. Didier Vander Steichel

▪ Mr. Patrick Crombez

▪ Mr. Ayhan Findik

▪ Dr. Marie Mailleux

▪ Mrs. Karolien Haese


“CODE and the ODN”

Dr. Ashley Woolmore

Senior Vice President, IQVIA CODE Founder


“In a world

without data,

opinion

prevails”

The role of data in healthcare

#datasaveslives: Farr Institute, UK


Goal of CODE and the Oncology Data Network

9

1. To support your efforts as the community of practice, to continue driving

improvements in quality of care

2. To reduce the complexity and effort of getting insight from real-world data

3. To create a ‘system’, create fast feedback, to use the data that are already collected

4. To facilitate cross-centre, cross-country comparability


How did we move forward with the ODN?

10

Privacy

Proactive

Scale

Automation

• Privacy by Design: a fully GDPR compliant infrastructure and processes

• Engagement and partnerships with European and National

organisations, including patient representatives

• Establishment of Information Access policies

• Currently 7 EU countries, with combined of population c.300Mn

• An imperative in the era of personalisation

• Cutting edge technology infrastructure and data science capabilities

• Technology reduces burden on clinical teams


Latency: The most under appreciated characteristic of real-world data

11

The delay (in years, months, weeks, days, hours, minutes…) between a

clinical event and our ability to access analysis of that event

…or, to access analytically-ready data that describe clinical event(s)

Highly relevant for:

Clinical Applications Research Applications Access Applications


External

References

Constitution of

evidence-based

references to facilitate

interpretation

(e.g. CRRL)

Translation

Translation to a ‘common

language’, a full common

data model of anti-cancer

treatment, without “loss in

translation”

Achieving the goals of ODN

12

“Native”

Languages

Centres ‘speak’ their own

language, using their own

systems

1 2 3


Emerging value that we’re seeing and that we are anticipating

13

1. Insight into own data (and its improvement) and centres’ own clinical practice

2. Contextualise centres’ own practice:

• Others in the network (clusters of centres, or sub-networks)

• Accessing references from the evidence base

3. Creating connections amongst ODN members and the community of practice

4. ODN as the ‘backbone’ for more ambitious data collection:

• Creation of metrics for ‘Pragmatic Outcomes’ (ECCO partnership)

• Appending study-specific data items and processes

• Appending and extending data sources (PRD, mDX)


Our approach to the establishment and growth of the ODN

14

Open

Invitation• Supported implementation; no cost to ODN members

Under Your

Control• You retain control over your data

Smart

Automation• Implementation via existing systems

• No incremental data entry effort

Privacy• Full GDPR compliance

• Privacy-protecting analytics

• CASC (EU) and CAGs (Country)

• IAPP governs data access and publication rulesGovernance

Copyright © 2018 IQVIA, All Rights Reserved. Confidential and Proprietary.Copyright © 2018 IQVIA, All Rights Reserved. Confidential and Proprietary. 15

CODE Collaboration as a partnership

• A collective, collaborative approach as an alternative to ‘single company’

• Information Governance and ‘finaltiés’ specifically includes use for ‘access’ and

agreement types

• Stated objectives of financial sustainability, via CODE Charter (www.code-cancer.com)

• Relationship encapsulated in a clear governance structure


We have already made significant progress on that journey, but nowhere near enough

16

➢ 90 Members from across 5 countries

➢ Infrastructure confirmed as “best in class”

at protecting patient and clinician data

privacy from DPAs

➢ Have started delivering information that

shows that the platform can deliver on

CODE’s core objectives

Current ODN Footprint

Members

Late stage

discussions


“HCP participation - joining the Oncology Data

Network”

Mrs. Mirella Koenjer

Program Manager Oncology at

Gelre Ziekenhuizen

Even voorstellen

• Passie: goede zorg en behandeling voor de patiënt

Wat kan ODN de partijen bieden?

1. Voor de Patiënt

2. Voor de Behandelaar

3. Voor het Ziekenhuis/ netwerk

4. In Nederland

Patiënt

• Beste behandeling

• Laatste inzichten

• Ook als je 70 jaar bent

• Informatie die helpt bij de keuze

• Inzicht in welke behandeling past bij wat ik als patiënt belangrijk vind

Behandelaar

• Wil de patiënt antwoord geven op de vraag: “Welke behandeling past

bij mij?“

• Inzicht in eigen handelen als behandelaar; kwantiteit/kwaliteit

• Onderzoeken sneller en eenvoudiger

Nederland

• Zorgkosten om laag door beter gebruik

• Kosten onderzoek naar beneden

• Zorg afgestemd op behoeve van de patiënt

Uitdagingen

• Vertrouwen in data

• Geen extra registratielast

• Koppelen van systemen (zorg thuis)

• Missing data

• Userinterface eenvoudig

• Hoe ook uitkomsten als kwaliteit van leven koppelen

• PROM/PREM koppelen?

Toekomst

Voor dé unieke patiënt, dé behandeling kunnen aanbieden die (volgens de data van vandaag) aan die patiënt de hoogste kwaliteit van leven kan geven.


“S.I.O and CODE, the benefits of a collaboration”

Mr. Patrick Crombez

Department Head Hematology at Institut

Jules Bordet


1ère journée de perfectionnement de la SIO Bruxelles 04/12/2018

Les avantages d’une collaboration

entre la SIO et CODE


Stakeholders Professionnels d’Oncologie


SIO – CODE : une force unie

29

Nécessité de partage de données est

un besoin réel en santé public

les infirmiers n’y échappe pas


SIO – CODE- Fondation contre le cancer : une force unie

30

Un groupe pluridisciplinaire de parties prenantes

incluant des cancérologues, des organisations de

patients et des infirmiers pour conseiller le

développement de réseau, l'engagement avec des

organismes nationaux et la pratique clinique à un niveau

national

Copyright © 2018 IQVIA, All Rights Reserved. Confidential and Proprietary. 31

Au niveau de la Belgique, les hôpitaux montrent

également beaucoup d’intérêt mais le système complexe

de santé de notre pays fait que la démarche prend un

peu plus de temps

Il est important de comprendre qu’il n y a pas que l’avis

des oncologues qui doit être prise en compte pour

l’implémentation du projet, celui des infirmiers est

autant important


Copyright © 2018 IQVIA, All Rights Reserved. Confidential and Proprietary. 32

SIO peut fournir l'expertise locale pour contribuer à

l'initiative et aider à identifier des tendances dans la

pratique clinique (outpatient) au niveau national



Country Advisory Groups: une occasion d'engager les Infirmiers d'Oncologie directement dans CODE

33

Rôles Specifiques :

• aider à maximiser la valeur pour les patients et d'autres stakeholders

• Aider à guider l'engagement avec les organismes et organisations nationaux

• Identifier les opportunités de croissance du réseau et s'engager davantage avec

les organisations de patients

• Identifier des opportunités pour des analyses et des recherches au niveau du pays

• Aider à identifier les tendances de la pratique clinique au niveau national


Avantages pour la SIO et les Infirmiers en Oncologie

34

➢ Partage d’expérience

➢ Visibilité sur des données épidémiologiques

➢ Accès aux données de recherche

➢ Meilleure connaissance des nouvelles thérapies

➢ Meilleure connaissance et gestion des effets secondaires

➢ Standardisation des procédures (benchmarking)

➢ Informer la pratique clinique pour développer l’Evidence-Based Practice

➢ Identifier les besoins de la recherche infirmière

➢ Informer et défendre la politique en soins infirmiers (policy-making), infirmiers de pratique avancée, standardisation des qualifications infirmière en oncologie

➢ Source permanente d’actualisation de la pratique infirmière en oncologie


EONS’ goals are aligned with CODE’s work and offer insights into potential areas of collaboration

35

EONS’ goals How CODE/ODN can

support this

How EONS can help

Communication EONS fosters and promotes

communication across the

nursing Community

Building a cooperative data

sharing network is an

example of communication in

action

Raise awareness of CODE

and ODN amongst

membership

Advocacy Promoting the vital role of

oncology nurses in MDTs.

Addressing challenges facing

oncology such as financial

sustainability

Provide information to support

specific advocacy objectives

and a tool to help find

solutions e.g. addressing

challenges of financial

sustainability

Support development of the

ODN

Research EONS promotes evidence

based clinical practice,

identifying and addressing

variability in care

ODN has been designed to

enable comparability and

hence identify variations in

treatment with anti-cancer

medicines

Promote development of the

ODN as a resource which can

then be used to identify

studies which highlight

variability of care.

Education Education is critical to keep

pace with innovations in

clinical care

Info from the ODN provides

insights into how medicines

are being used

Train nurses on the value of

information from the ODN and

how they can harness this


Nurses play an important role in data gathering and usage to inform patient care and policy

36

Ways in which nurses support data quality, information access and can harness it to maximise their impact

Nurses support

patients to enhance

Patient Reported Data

Nurses report clinical

data in EMRs

Nurses can use

information to support

patient advocacy in

MDTs

Nurses can use

information to support

policy advocacy role

(RECaN-project)

Nurses can harness the

power of data to enhance

and inform their advocacy

role

Nurses enhance data

scope, quality and

availability for review and

analysis

Nurses help ensure

patients understand how

their data will be used and

ensure they are aware of

the mechanism to opt-out

1 2 3


Proposal of collaboration with EONS to develop a survey & training programme for oncology nurses

37

Module Topic Outcome

The Medical Oncology Data landscape

Gain insights into the data landscape across Europe and identify the sources of oncology data within their hospitals. They will also be introduced to the Oncology Data Network, which can be used to explore variation in use of anti-cancer medicines both in their hospitals and across the network.This learning will allow nurses to better engage and support patients and also understand what resources are available to them in their advocacy roles.

Patient data in the GDPR era

Understand impact of GDPR on data capture and reporting. Give nurses information to support discussions with patients about data privacy – ensuring they stay compliant with hospital policy and procedures.

The rise of patient reported data

Understand the growing importance of Patient Reported Data, how to support patients with sharing these data and ensuring they are captured and accessible to support clinical decision making.

The importance of data quality

Understand the importance of good data quality and the role nurses can play in enhancing this. Colloquially known by data scientists as GIGO (Garbage In, Garbage Out).

Turning data into information and actionable insights

Gain insights into how information sources and analyses can help inform their work and increase their effectiveness as patient advocates within MDT and more broadly at policy level. Identify tools and skills to help them realise their role as advocates.

Proposed title for programme:

“Oncology Nurses – at the heart of realising the potential for data

to inform patient care and policy”


Timeline and next steps

38

2018 2019

Aug Sep Oct Nov Dec Jan Feb Mar

P. Crombez to present to EONS Board and capture initial feedback

Draft agreement

Activity

ESMO

Refine programme materials

Hold Training workshop To test programme content and materials

Circulate materials to EONS members

Ongoing communications to EONS Members about the programme

Plan Training Workshop

Agreement and announcement confirmedat EONS meeting during ESMO

Develop content for programme Meeting with Advisory Group of Oncology Nurses & other stakeholders

ESMO

Draft announcement of agreement forEONS approval

To discuss: Applying for CPD credits for the programme


“The advantages of the CODE initiative

for the CAPRI III project”

Mr. Malou Kuppen

PhD Candidate iMTA/RadboudUMC

CAPRI III project and CODECastration-Resistant Prostate Cancer Registry

Castration-resistant prostate cancer registry (CAPRI)

- Investigator-initiated registry with successful collaboration between professionals, patients,

researchers and pharmaceutical companies

- Aim: every CRPC patient should receive the best, new treatment

- Over 3,500 pts from 2010-2016 with minimum follow-up of 2 years

- Considered as the source of data on appropriate care for mCRPC patients by the Dutch Health

Care institute

CAPRI 2012 - 2018

- 40,000 records 3,600 CRPC patients included in CAPRI registry

- manually collected in 20 hospitals

- 2 PhD students, many students

- 80% data collection 20% data analysis

- Sponsorship: 4 Pharma companies

Considerable labour/costs in current project

RW research data quality requires costly manual curation

• Identify cases in

hospital system(s)

• Pseudonymise data

• Examine data and

resolve ambiguities

• Re-key data

• Examine data for

completeness and

for discrepancies

• Correct data at

source

CAPRI20 hospitals, high data curation effort

c. 80 hospitals, considerable data curation effortIKNL

Search source

data

Manual

review

Quality

checks

Achieving high quality data has been c.80% of CAPRI efforts and cost to date

Aim: every CRPC patient should receive the best, new treatment

Registry for treatment in mCPRC

- 20% data collection 80% data analysis

Goal:

CAPRI Project 2018-2023

• More patients • Same Budget

• More Hospitals • Quality control

• More data • Privacy

• International Validation • Data Linking

Electronic data

collection

1. Data quality level has to be research-grade

2. Creates significant time and money savings overall

3. Full compliance with GDPR and country-specific data protection and privacy laws

Three things have to be true to deploy these technologies

1. Research-grade automated data collection

Class Subclass Quality

Data Returned • From reliable fields e.g. lab values• From mixed fields e.g. tumour type

• From less reliable fields e.g. date of diagnosis

• High

• Medium-high

• Low

Query Failure Data existed, but not found• Data model driven e.g. TNM

• Data type driven e.g. Gleason scores

• Query driven e.g. treatment plan changes

• N/A

Needs specific assessment of data

model / query

Practice of Medicine Data Voids

Data was never in the records e.g.

- other hospital treated patient in part

- clinician knew data, but never entered it in record

(tacit knowledge)

- data never collected

• N/A

Only solution is structured entrance

of data in patient records

2. Three areas of labour savings from automation technologies

Higher % inclusion; faster

patient finding

Full automation of

extraction where data

quality high

Semi-automation

where human review

required

Potential labour savings in CAPRI automation could be >50% overall

Half or more the time to check these fields manually

Double % CAPRI positive records in long list

Cut an hour per patient from re-keying lab values (Hb, ALP, LDH, PSA, albumin)

Make records easy to navigate for human review, and for unstructured queries suggest possible coded results for human selection

Enrich initial long list of possible records to be checked for study inclusion, and so reduce “patient finding” labour

Remove re-keying and human review from data fields where query quality is high (e.g. structured data)

Patient data remain under the control of the treatment centres

1. Only hospitals have access to their own patient-level data

2. State-of-the-art privacy technology is used to make the data non-identified and ensure compliance with GDPR and country data privacy and protection rules

3. Will work with nominated data privacy and data protection experts to provide information on the approach

3. Compliant with data protection and data privacy laws


Patients/Hospitals

University

Sponsors

PhysiciansCODE/CT CUE

IKNL

Benefits for every partner in this project


Patients Access to new treatments, access to the best treatment, prognosis

University Best analysis (cost-benefit), major impact on cancer health care, personalized cancer care, data sharing for research

Physicians What is best practice, are patients surviving longer, sequence treatment: one fits all, or personalized medicine, value based health care

IKNL National Cancer Registry, top European registries, best quality control

Sponsors Added value of their drugs/diagnostics: value based health care

CT CUE/CODE Best Tools best reports, best privacy protection

Future Possibilities

Patients/Hospitals

University

Sponsors

PhysiciansCODE/CT CUE

IKNL

CPCT-02ClinicalTrials

Trust

Trust

Trust

Trust

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