Patient Partner

Patient Involvement in Clinical Research In Relationship with Biobanking BBMRI - 15 December 2009 Cor Oosterwijk Project Coordinator PatientPartner Dutch Genetic Alliance VSOP European Genetic Alliances’ Network EGAN

Challenges
Administrative burden, costs, delays (European competitiveness)
Risk/benefit assessment, especially i.r.t. advanced therapies
Patient recruitment
Personalised medicine
Ethical and regulatory issues related to
patient registries / biobanking
paediatric research
stakeholder relationships
Public perception and awareness

Public perception of clinical research

Added value of patient participation
Before
Identification of indications, therapy features, patient population
Patient perspective on ethical and risk/benefit dilemmas
Defining patient-oriented outcome measures
During
Managing of expectations: hope or hype
Patient inclusion and compliance
Data quality
Patient and public confidence in clinical research
After:
Patients’ quality of life
Better compliance to therapies
(Cost-)effectiveness of healthcare

PatientPartner
DG Research – Health Directorate, Call identifier FP7-HEALTH-2007-A, 22/12/2006 – 19/4/2007. Coordination and support actions across the health theme: Health-2007-4.1-4:
Identifying patients’ needs in the clinical trial context
How can patients be better mobilized and empowered in the clinical trials landscape
Which are the clinical outcomes that really matters to patients,
how can they be integrated into clinical trials.

PatientPartner
Objectives
identification of patients needs (yr 1)
dialogue with other stakeholders on those needs and consensus development (yr 2)
identification of regional differences (yr 2)
development of (regional) strategies and recommendations for implementation (yr 3)

Consortium
Patient Alliances
Genetic Interest Group (GIG)
Dutch Genetic Alliance (VSOP)
European Genetic Alliances’ Network (EGAN)
Multi-Stakeholder NGO
European Forum for Good Clinical Practice (EFGCP)

PatientPartner May 2008 – May 2011
ENPCR: www.enpcrtest.forumotion.com
patient registries and biobanks
pediatric clinical research
ethical issues (stakeholder relationship, transparency)
information and education

Dissemination
Guides and Recommendations
At European and national levels
For:
Patients Organizations
Academic and Biopharmaceutical Investigators, Sponsors and CROs
Regulators, (Ethics) Committee’s, etc
The PatientPartner website will be transformed to facilitate contacts and partnerships between academic / biopharmaceutical stakeholders and patient organizations

Biobanks, clinical research and PatientPartner
Validated biobanks increase the (cost)effectiveness of clinical research
P.o. are a trusted third party to
Connect the basic and the clinical research field
Connect and integrate separate data/biobanks, both basic and clinical
Connect with individuals to obtain actual medical data and/or biological samples
PatientPartner is about creating equal relationships.
PatientPartner pays special attention to the role of p.o. concerning data/biobanks that are used in (pre)clinical research.
BBMRI Patient Working Group and PatientPartner can work together on recommendations related to the role of p.o. in biobanks for (pre)clinical research.

Levels of Patient Participation in Clinical Research 30/12/09 Reviewer Co-researcher Driving force Research subject Information provider Advisor

30/12/09 Outcome PatientPartner survey Co-researcher Advisor Information Provider Research subject Driving Force Reviewer

Patient entrepreneurship in biobanking

Genetic Alliance BioBank Functioning
Enable IRB approved investigator research that otherwise would not happen
Ensure appropriate use of samples & data
Enable ethical re-contact and follow-up for phenotype/genotype correlations, natural history and longitudinal studies
Advocacy organization control & benefit sharing
www.biobank.org By: Patrick F. Terry ©

EGAN-EPPOSI conference report ‘Biobanks, the entrepreneurial role of patient organizations (2006)
Pseudoxanthoma Elasticum (PXE)
Alternating Hemiplegia of Childhood ( www.enrah.org )
Hemophilia (NL)
Pompe’s disease (www.worldpompe.org)
Inflammatory bowel / Crohn’s disease (IBD warehouse)
www.egan.eu
www.epposi.org

PatientPartner preliminary findings
Much agreement on the need for pp in clinical research
No one-fits-all model: different needs and capacities within patient organisations
Minor differences within Europe regarding needs, major differences regarding possibilities
How to find each other and how to match infrastructures and cultures?
Some research professionals fear delay and additional bureaucracy

PatientPartner preliminary outcomes
Stimulate and facilitate both virtual and ftf contact between clinical research professionals and patient organisations
Basic, uniform training and information for the patient field is needed.
P.o. want to be involved at a governance level: in the setting of research priorities, protocol development and ethical review
User friendly databases are needed for research professionals on p.o. capacities irt clinical research and for p.o. on actual clinical research opportunities
More efforts are needed to address the media and the public on the nature of clinical research and the position of patients in it.

Take home message
Patient partnership in biomedical and clinical research is
not (only) a right (“Nothing about us without us”)
but a medical, scientific, ethical,
and even economic necessity
that also brings responsibilities to p.o.
Start partnering there where everybody involved
is convinced of the added value
and explore further possibilities from thereon.

www.patientpartner-europe.eu www.enpcrtest.forumotion.com www.biomedinvo4all.com BBMRI Patient Working Group and PatientPartner can work together on recommendations related to the role of p.o. in biobanks for (pre)clinical research.

Patient Partner

by BBMRI Stakeholder's Forum on Dec 30, 2009

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Patient Partner — Presentation Transcript