Patient Involvement in Clinical Research In Relationship with Biobanking  BBMRI - 15 December 2009 Cor Oosterwijk Project ...
Challenges  <ul><li>Administrative burden, costs, delays (European competitiveness) </li></ul><ul><li>Risk/benefit assessm...
Public perception of clinical research
Added value of patient participation <ul><ul><li>Before </li></ul></ul><ul><ul><li>Identification of indications, therapy ...
PatientPartner <ul><li>DG Research – Health Directorate, Call identifier FP7-HEALTH-2007-A, 22/12/2006 – 19/4/2007. Coordi...
PatientPartner <ul><li>Objectives </li></ul><ul><ul><li>identification of patients needs (yr 1) </li></ul></ul><ul><ul><li...
Consortium <ul><li>Patient Alliances </li></ul><ul><li>Genetic Interest Group (GIG) </li></ul><ul><li>Dutch Genetic Allian...
PatientPartner   May 2008 – May 2011 <ul><ul><ul><li>ENPCR: www.enpcrtest.forumotion.com </li></ul></ul></ul><ul><ul><ul><...
Dissemination <ul><li>Guides and Recommendations </li></ul><ul><li>At European and national levels  </li></ul><ul><li>For:...
Biobanks, clinical research and PatientPartner <ul><li>Validated biobanks increase the (cost)effectiveness of clinical res...
Levels of Patient Participation in Clinical Research 30/12/09 Reviewer Co-researcher Driving force Research subject Inform...
30/12/09 Outcome PatientPartner survey Co-researcher Advisor Information  Provider Research subject Driving Force Reviewer
 
Patient entrepreneurship in biobanking
Genetic Alliance   BioBank   Functioning <ul><li>Enable  IRB approved investigator research that otherwise would not happe...
<ul><li>EGAN-EPPOSI conference report  ‘Biobanks, the entrepreneurial role of patient organizations (2006) </li></ul><ul><...
PatientPartner preliminary findings <ul><li>Much agreement on the need for pp in clinical research </li></ul><ul><li>No on...
PatientPartner preliminary outcomes <ul><li>Stimulate and facilitate both virtual and ftf contact between clinical researc...
Take home message <ul><li>Patient partnership in biomedical and clinical research is  </li></ul><ul><li>not (only) a  righ...
www.patientpartner-europe.eu   www.enpcrtest.forumotion.com www.biomedinvo4all.com BBMRI Patient Working Group and Patient...
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Patient Partner

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  • Alle algemene problematiek van klinische research komt samen in pediatrische research
  • Patient Partner

    1. 1. 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
    2. 2. Challenges <ul><li>Administrative burden, costs, delays (European competitiveness) </li></ul><ul><li>Risk/benefit assessment, especially i.r.t. advanced therapies </li></ul><ul><li>Patient recruitment </li></ul><ul><li>Personalised medicine </li></ul><ul><li>Ethical and regulatory issues related to </li></ul><ul><ul><li>patient registries / biobanking </li></ul></ul><ul><ul><li>paediatric research </li></ul></ul><ul><ul><li>stakeholder relationships </li></ul></ul><ul><li>Public perception and awareness </li></ul>
    3. 3. Public perception of clinical research
    4. 4. Added value of patient participation <ul><ul><li>Before </li></ul></ul><ul><ul><li>Identification of indications, therapy features, patient population </li></ul></ul><ul><ul><li>Patient perspective on ethical and risk/benefit dilemmas </li></ul></ul><ul><ul><li>Defining patient-oriented outcome measures </li></ul></ul><ul><ul><li>During </li></ul></ul><ul><ul><li>Managing of expectations: hope or hype </li></ul></ul><ul><ul><li>Patient inclusion and compliance </li></ul></ul><ul><ul><li>Data quality </li></ul></ul><ul><ul><li>Patient and public confidence in clinical research </li></ul></ul><ul><ul><li>After: </li></ul></ul><ul><ul><li>Patients’ quality of life </li></ul></ul><ul><ul><li>Better compliance to therapies </li></ul></ul><ul><ul><li>(Cost-)effectiveness of healthcare </li></ul></ul>
    5. 5. PatientPartner <ul><li>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: </li></ul><ul><li>Identifying patients’ needs in the clinical trial context </li></ul><ul><ul><ul><li>How can patients be better mobilized and empowered in the clinical trials landscape </li></ul></ul></ul><ul><ul><ul><li>Which are the clinical outcomes that really matters to patients, </li></ul></ul></ul><ul><ul><ul><li>how can they be integrated into clinical trials. </li></ul></ul></ul>
    6. 6. PatientPartner <ul><li>Objectives </li></ul><ul><ul><li>identification of patients needs (yr 1) </li></ul></ul><ul><ul><li>dialogue with other stakeholders on those needs and consensus development (yr 2) </li></ul></ul><ul><ul><li>identification of regional differences (yr 2) </li></ul></ul><ul><ul><li>development of (regional) strategies and recommendations for implementation (yr 3) </li></ul></ul>
    7. 7. Consortium <ul><li>Patient Alliances </li></ul><ul><li>Genetic Interest Group (GIG) </li></ul><ul><li>Dutch Genetic Alliance (VSOP) </li></ul><ul><li>European Genetic Alliances’ Network (EGAN) </li></ul><ul><li>Multi-Stakeholder NGO </li></ul><ul><li>European Forum for Good Clinical Practice (EFGCP) </li></ul>
    8. 8. PatientPartner May 2008 – May 2011 <ul><ul><ul><li>ENPCR: www.enpcrtest.forumotion.com </li></ul></ul></ul><ul><ul><ul><li>patient registries and biobanks </li></ul></ul></ul><ul><ul><ul><li>pediatric clinical research </li></ul></ul></ul><ul><ul><ul><li>ethical issues (stakeholder relationship, transparency) </li></ul></ul></ul><ul><ul><ul><li>information and education </li></ul></ul></ul>
    9. 9. Dissemination <ul><li>Guides and Recommendations </li></ul><ul><li>At European and national levels </li></ul><ul><li>For: </li></ul><ul><ul><li>Patients Organizations </li></ul></ul><ul><ul><li>Academic and Biopharmaceutical Investigators, Sponsors and CROs </li></ul></ul><ul><ul><li>Regulators, (Ethics) Committee’s, etc </li></ul></ul><ul><ul><li>The PatientPartner website will be transformed to facilitate contacts and partnerships between academic / biopharmaceutical stakeholders and patient organizations </li></ul></ul>
    10. 10. Biobanks, clinical research and PatientPartner <ul><li>Validated biobanks increase the (cost)effectiveness of clinical research </li></ul><ul><li>P.o. are a trusted third party to </li></ul><ul><ul><li>Connect the basic and the clinical research field </li></ul></ul><ul><ul><li>Connect and integrate separate data/biobanks, both basic and clinical </li></ul></ul><ul><ul><li>Connect with individuals to obtain actual medical data and/or biological samples </li></ul></ul><ul><li>PatientPartner is about creating equal relationships. </li></ul><ul><li>PatientPartner pays special attention to the role of p.o. concerning data/biobanks that are used in (pre)clinical research. </li></ul><ul><li>BBMRI Patient Working Group and PatientPartner can work together on recommendations related to the role of p.o. in biobanks for (pre)clinical research. </li></ul>
    11. 11. Levels of Patient Participation in Clinical Research 30/12/09 Reviewer Co-researcher Driving force Research subject Information provider Advisor
    12. 12. 30/12/09 Outcome PatientPartner survey Co-researcher Advisor Information Provider Research subject Driving Force Reviewer
    13. 14. Patient entrepreneurship in biobanking
    14. 15. Genetic Alliance BioBank Functioning <ul><li>Enable IRB approved investigator research that otherwise would not happen </li></ul><ul><li>Ensure appropriate use of samples & data </li></ul><ul><li>Enable ethical re-contact and follow-up for phenotype/genotype correlations, natural history and longitudinal studies </li></ul><ul><li>Advocacy organization control & benefit sharing </li></ul>www.biobank.org By: Patrick F. Terry ©
    15. 16. <ul><li>EGAN-EPPOSI conference report ‘Biobanks, the entrepreneurial role of patient organizations (2006) </li></ul><ul><ul><li>Pseudoxanthoma Elasticum (PXE) </li></ul></ul><ul><ul><li>Alternating Hemiplegia of Childhood ( www.enrah.org ) </li></ul></ul><ul><ul><li>Hemophilia (NL) </li></ul></ul><ul><ul><li>Pompe’s disease (www.worldpompe.org) </li></ul></ul><ul><ul><li>Inflammatory bowel / Crohn’s disease (IBD warehouse) </li></ul></ul><ul><li>www.egan.eu </li></ul><ul><li>www.epposi.org </li></ul>
    16. 17. PatientPartner preliminary findings <ul><li>Much agreement on the need for pp in clinical research </li></ul><ul><li>No one-fits-all model: different needs and capacities within patient organisations </li></ul><ul><li>Minor differences within Europe regarding needs, major differences regarding possibilities </li></ul><ul><li>How to find each other and how to match infrastructures and cultures? </li></ul><ul><li>Some research professionals fear delay and additional bureaucracy </li></ul>
    17. 18. PatientPartner preliminary outcomes <ul><li>Stimulate and facilitate both virtual and ftf contact between clinical research professionals and patient organisations </li></ul><ul><li>Basic, uniform training and information for the patient field is needed. </li></ul><ul><li>P.o. want to be involved at a governance level: in the setting of research priorities, protocol development and ethical review </li></ul><ul><li>User friendly databases are needed for research professionals on p.o. capacities irt clinical research and for p.o. on actual clinical research opportunities </li></ul><ul><li>More efforts are needed to address the media and the public on the nature of clinical research and the position of patients in it. </li></ul>
    18. 19. Take home message <ul><li>Patient partnership in biomedical and clinical research is </li></ul><ul><li>not (only) a right (“Nothing about us without us”) </li></ul><ul><li>but a medical, scientific, ethical, </li></ul><ul><li>and even economic necessity </li></ul><ul><li>that also brings responsibilities to p.o. </li></ul><ul><li>Start partnering there where everybody involved </li></ul><ul><li>is convinced of the added value </li></ul><ul><li>and explore further possibilities from thereon. </li></ul>
    19. 20. 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.

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