Patient Advocates in Cancer Research: European Patients’ Perspective - Jan Geissler
Patient Advocates in Cancer Research:European Patients‟ Perspective ISOQOL 19th ANNUAL CONFERENCE, BUDAPEST, 26 OCT 2012 JAN GEISSLER Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)Co-founder, CML Advocates Network / Leukemia Patient Advocates Foundation Secretary, European Forum For Good Clinical Practice Member, EU Committee of Experts for Rare Diseases (EUCERD)
We„re excited about progress intackling cancer… but… Molecular targets/pathways New approaches needed Genome sequencing Drug Translational research Drug+Pathway Personalized medicine +Biomarker • Small trial populations New trial design • Biomarkers and recruitment HTA, QoL, endpoints, New collaboration comparators models Healthcare budgets vs Patients in drug pricing research 2
There is no „magic bullet“for most patients yet “Success stories” available only to small numbers of rare cancers Patients in urgent need of therapeutic innovation 5-year survival in cancer (USA, 2008) National Cancer Institute RareCare (Gatta et al, 2012)
Patients with rare cancersface specific challenges1. Prevention and screening mostly irrelevant2. Late or incorrect diagnosis3. Experienced doctor not available locally, lack of access to clinical expertise4. Lack of appropriate therapies5. Slowness of research (lack of trials & commercial interest),6. Facing stigma and inequity7. Lack of information & local patient groups
In addition, public misperception ofclinical trials delay research ?Lack of public confidence…= delayed / lack of trial recruitment= delayed generation of meaningful data= slow progress, lack of research in Europe
What patients want to knowabout clinical trials Knowing that trials exist at all Benefits of participation in trials: • Personal benefit: Innovative treatment, closer monitoring, better QoL, chance for response, "last resort" • Altruistic reasons: Achieving progress beyond their own case
What patients need to knowabout RISKS in clinical trials Medical risk of uncertain therapies Quality of life, unpleasant diagnostics Paediatric trials: administration Influence on family life (intensity of care) Financial impact (travel), ability to work (patient & carers) Fertility Protection from stigma and discrimination (use of data) Patient groups: the only stakeholder with the big picture on QoL of a patient population
Doctor/patient perception on impact on QoL differsDetecting Myeloma, ways to shortening an often painful and tedious patient odyssey: results from an internationalsurvey. Myeloma Euronet (2009). 314 physicians & nurses, 260 patients & carers, 43 countries
Doctor/patient perception on management of side effects differsDetecting Myeloma, ways to shortening an often painful and tedious patient odyssey: results from an internationalsurvey. Myeloma Euronet (2009). 314 physicians & nurses, 260 patients & carers, 43 countries
Patients – as partners ofresearchers“ More needs to be done: rare cancers will never be a priority unless the patients make it one. Patients themselves must therefore play a larger role in driving forward the search for therapies. They are „ able to see connections that have eluded scientists.
Collaborative cancer research:More participation of patient groups Before research starts • Influencing public health / research policy • Identification of indications, therapies, patient population, gaps • Uncovering ethical and risk/benefit dilemmas • Assessing endpoints (PFS vs OS) While research is done • Managing of expectations: hope or hype Driving force • Patient recruitment, compliance Co-researcher • Side effect monitoring Reviewer • Patient & public confidence in clinical research Advisor After conclusion of research Information provider • Quality of life monitoring in “the field” • Assessment of (cost-)effectiveness Research subject • Improving compliance Source: PatientPartner FP7 Project (2010)
Opportunities improvinginformed consent Patient-driven optimization of informed consent ToC, Glossary, study flow chart, terminology, videoEudraCT-Nr. 2010-024262-22, „TIGER“ Study in CML
CML Advocates Network:Community-driven adherenceresearch Pilot survey completed in 2011, phase II in Sept 2012 in 12 languagesGoal: CML treatment adherence (intentional, non-intentional) Interaction with physician (Use of) adherence tools 1000 patients in 3 weeks, 3000 until EOY2012
Patient-driven biobanking in cancer• PATH - Patients Tumorbank of Hope – Initiated by breast cancer patient group MAMAZONE (DE) – Samples stored for research and individual use – Collected >5475 samples in 7 breast centers to date• The GIST Collaborative Tissue Bank – Initiated by the Life Raft Group (USA) – Patients receive mutational testing on the Primary Mutation
Self-reported QoL data acceleratingclinical discovery “the first real-time, real- world, open and non- blinded, patient-driven trial” …"Although observational studies using un-blinded data are not a substitute for double- blind randomized control trials, this study reached the same conclusion as subsequent randomized trials” …”Accelerating clinical discovery and evaluating the effectiveness of drugs already in use."
Unmet need of patient and public oninformation on medicines R&D Patients… • seek up-to-date, credible, understandable information about innovation in treatments • are largely unaware about clinical trials, translational research, personalized medicine, pharmaco-economics, their key role Patient advocates… • like to advise on protocol design, informed consent, ethical review, marketing authorization, value assessment, health policy • lack the education and training required to participate as a partner in medicines R&D
EUPATI: Empoweringpatients on medical R&D Launched Feb 2012, runs for 5 years, 29 consortium members, PPP of EU Commission and EFPIA will develop and provide, objective, credible, correct, up-to-date knowledge about medicines R&D will build competencies & expert capacity among patients & public will facilitate patient involvement in R&D to support industry, academia, authorities and ethics committees
Areas covered by EUPATI1. Medicines development process from research to approval2. Personalized and predictive medicine3. Drug safety and risk/benefit assessment of medicines4. Pharmaco-economics, health economics and health technology assessment5. Design and objectives of clinical trials (& roles of stakeholders) …and NOT: develop indication-6. Patients roles & responsibilities in or therapy-specific medicines development information!
Audiences: advocacy leadersand the public at large 100 EUPATI Certificate patient Training Programme advocates English French 12.000 German EUPATI Educational patient Spanish Toolbox advocates Polish Italian Russian EUPATI 100.000 Internet Library individuals
Summary Key goal of research: To get better answers to cancer patients more quickly. Patient participation makes research more successful • make design of trials patient-centric • communication of trials with patients, improving "informed consent" • improve quality of life assessment Training of patient groups to foster cooperation with clinicians, cancer researchers, authorities, industry is essential!
Get to know us! Web: www.patientsacademy.euJan GeisslerEUPATI Director Twitter: @email@example.com as well as: