Pa#ent Involvement in Clinical Research In Rela#onship with Biobanking BBMRI 15 December 2009
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1 Pa#ent Involvement in Clinical Research In Rela#onship with Biobanking BBMRI 15 December 2009 Cor Oosterwijk Project Coordinator Pa;entPartner Dutch Gene;c Alliance VSOP European Gene;c Alliances Network EGAN
2 Challenges Administra;ve burden, costs, delays (European compe;;veness) Risk/benefit assessment, especially i.r.t. advanced therapies Pa;ent recruitment Personalised medicine Ethical and regulatory issues related to pa;ent registries / biobanking paediatric research stakeholder rela;onships Public percep;on and awareness
3 Public percep;on of clinical research
4 Added value of pa;ent par;cipa;on Before Iden;fica;on of indica;ons, therapy features, pa;ent popula;on Pa;ent perspec;ve on ethical and risk/benefit dilemmas Defining pa;ent oriented outcome measures During Managing of expecta;ons: hope or hype Pa;ent inclusion and compliance Data quality Pa;ent and public confidence in clinical research Pa;ents quality of life BeXer compliance to therapies (Cost )effec;veness of healthcare
5 Pa#entPartner DG Research Health Directorate, Call iden;fier FP7 HEALTH 2007 A, 22/12/ /4/2007. Coordina;on and support ac;ons across the health theme: Health : Iden#fying pa#ents needs in the clinical trial context How can pa-ents be be1er mobilized and empowered in the clinical trials landscape Which are the clinical outcomes that really ma1ers to pa-ents, how can they be integrated into clinical trials.
6 Objec;ves Pa#entPartner iden;fica;on of pa;ents needs (yr 1) dialogue with other stakeholders on those needs and consensus development(yr 2) iden;fica;on of regional differences (yr 2) development of (regional) strategies and recommenda;ons for implementa;on (yr 3)
7 Consor;um Pa;ent Alliances Gene;c Interest Group (GIG) Dutch Gene;c Alliance (VSOP) European Gene;c Alliances Network (EGAN) Mul; Stakeholder NGO European Forum for Good Clinical Prac;ce (EFGCP)
8 May 2008 May 2011 Pa-entPartner ENPCR: patient registries and biobanks pediatric clinical research ethical issues (stakeholder relationship, transparency) information and education
9 Dissemina#on Guides and Recommenda;ons At European and na;onal levels For: Pa;ents Organiza;ons Academic and Biopharmaceu;cal Inves;gators, Sponsors and CROs Regulators, (Ethics) CommiXee s, etc The Pa;entPartner website will be transformed to facilitate contacts and partnerships between academic / biopharmaceu;cal stakeholders and pa;ent organiza;ons
10 Biobanks, clinical research and Pa;entPartner Validated biobanks increase the (cost)effec;veness 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 Pa;entPartner is about crea;ng equal rela;onships. Pa;entPartner pays special axen;on to the role of p.o. concerning data/biobanks that are used in (pre)clinical research. BBMRI Pa#ent Working Group and Pa#entPartner can work together on recommenda#ons related to the role of p.o. in biobanks for (pre)clinical research.
11 Levels of Patient Participation in Clinical Research Driving force Co researcher Reviewer Advisor Informa#on provider Research subject 1/3/10 11
12 Outcome PatientPartner survey (Co)financing a clinical trial Raising funds for a par;cular clinical trial Geeng a research team together for a clinical trial Driving Force Developing the clinical research protocol Lobbying for (the development) of clinical trials for the condi;on(s) that your pa;ent organisa;on represents In other ways (as driving force) Transla;ng research results of a clinical trial into pa;ent friendly informa;on (Co)wri;ng a scien;fic ar;cle on the research results of the clinical trial Gathering research data Gathering informa;on Leading a focus group or discussion session Co researcher Interviewing pa;ents In other ways (as coresearcher) reviewer on pa;ent informa;on that is to be used in a clinical trial reviewer of a scien;fic paper on a clinical trial reviewer of a funding request for a clinical trial Reviewer reviewer of a clinical trial research protocol In other ways (as reviewer) Giving advise to or has been a (advisory) member of a clinical research program Giving advise to or has been a (advisory) member of a na;onal or European regulatory commixee for the development of a clinical trial Giving advise to or has been a (advisory) member of an ethics commixee authority commixee Advising on informed consent forms, the procedure for explaining the consent form to Advisor pa;ents, or the filling in of the consent form In other ways (as advisor) Supplying demographic and/or other characteris;c informa;on on the members that are Supplying informa;on to pa;ents on the possibili;es of taking part in one or more represented by your pa;ent organisa;on for the use in a clinical trial Informa#on Provider Supplying disease specific informa;on for the use in a clinical trial clinical trial(s) In other ways (as informa;on provider) Research subject As a contributor to a biobank or database for the use in a clinical trial By contribu;ng my DNA, cells or other biological material As a research subject in a clinical trial 1/3/10 In other ways (as research subject)
13 Pa#ent involvement in biobanking and medical databanks Raising funds for a biobank or a medical databank on the condi;on that is (co)financing a biobank or a medical databank Lobbying for the seeng up of a biobank or a medical databank on the condi;on Involved in maintaining and upholding a biobank or medical databank Involved in seeng up a medical databank e.g. a pa;ent registry Involved in seeng up a biobank As a contributor to a medical databank or biobank with DNA, cells, other biological In other ways Frequency % (n=205)
14 Pa;ent entrepreneurship in biobanking
15 Gene#c Alliance BioBank Func%oning Enable IRB approved inves;gator research that otherwise would not happen Ensure appropriate use of samples & data Enable ethical re contact and follow up for phenotype/ genotype correla;ons, natural history and longitudinal studies Advocacy organiza;on control & benefit sharing By: Patrick F. Terry
16 EGAN EPPOSI conference report Biobanks, the entrepreneurial role of pa;ent organiza;ons (2006) Pseudoxanthoma Elas;cum (PXE) Alterna;ng Hemiplegia of Childhood ( Hemophilia (NL) Pompe s disease ( Inflammatory bowel / Crohn s disease (IBD warehouse)
17 Pa;entPartner preliminary findings Much agreement on the need for pp in clinical research No one fits all model: different needs and capaci;es within pa;ent organisa;ons Minor differences within Europe regarding needs, major differences regarding possibili;es How to find each other and how to match infrastructures and cultures? Some research professionals fear delay and addi;onal bureaucracy
18 Pa;entPartner preliminary outcomes S;mulate and facilitate both virtual and kf contact between clinical research professionals and pa;ent organisa;ons Basic, uniform training and informa;on for the pa;ent field is needed. P.o. want to be involved at a governance level: in the seeng of research priori;es, protocol development and ethical review User friendly databases are needed for research professionals on p.o. capaci;es irt clinical research and for p.o. on actual clinical research opportuni;es More efforts are needed to address the media and the public on the nature of clinical research and the posi;on of pa;ents in it.
19 Take home message Pa;ent partnership in biomedical and clinical research is not (only) a right ( Nothing about us without us ) but a medical, scien;fic, ethical, and even economic necessity that also brings responsibili#es to p.o. Start partnering there where everybody involved is convinced of the added value and explore further possibili;es from thereon.
20 BBMRI Patient Working Group and PatientPartner can work together on recommendations related to the role of p.o. in biobanks for (pre)clinical research. 20
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