A snapshot of EUPATI: Why the educated patient is so vital to success in clinical trials - Jan Geissler - EUPATI Director

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A snapshot of EUPATI: Why the educated patient is so vital to success in clinical trials - Jan Geissler - EUPATI Director - presented at DIA EuroMeeting on 6 March 2013 in Amsterdam

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A snapshot of EUPATI: Why the educated patient is so vital to success in clinical trials - Jan Geissler - EUPATI Director

  1. 1. A snapshot of EUPATI:Why the educatedpatient is so vital tosuccess in clinical trialsJan GeisslerEUPATI Director 25th Annual EuroMeeting 4-6 March 2013 RAI, Amsterdam Netherlands
  2. 2. Unmet need of patient & public oninformation about 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, health economics, their key role in research• 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 drug research and development 2
  3. 3. Patients can largely contributeto medicines R&D• Before research starts – Identify indications, therapy gaps, patient population – Ethical/risk/benefit dilemmas – Patient-oriented outcome measures (PFS vs OS)• While research is in progress – Managing expectations: hope/hype Driving force – Patient recruitment, retention Co-researcher – Quality of life, side effect monitoring Reviewer• After conclusion of research Advisor – Dissemination of research results Information provider – Improving adherence – Assessment of (cost-)effectiveness Research subject 3
  4. 4. More educated patient advocates needed to be empowered for R&D Millions of patients& ICREL-Report 2009 ~5.000 100.000s of patient organisations clinical trials per year ~200 pan-EU patient organisations ~9.400 trial ~100 advocates applications per year with R&D expertise In 1.250 multinational rrials/year alone: 5.000 ethics panels, 35.000 ethics reviewers involved 4
  5. 5. The European Patients‘ Academy onTherapeutic Innovation  Launched Feb 2012  Runs for 5 years  30 consortium members  Funded by IMI JU (EU-FP7 and EFPIA) 5
  6. 6. Paradigm shift in empoweringpatients on medicines R&D Until end of 2016, EUPATI will …  develop and disseminate accessible, well-structured and user-friendly information and education on medicines R&D  build competencies and expert capacity about medicines R&D among patient advocates, patients and the public  create the leading public library on patient information in seven most common languages under public licensing  facilitate patient involvement in R&D to collaborate with academia, industry, authorities and ethics committees 6
  7. 7. Key topic areas1. 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, including role of all stakeholders6. Patients roles & responsibilities …but NOT: develop indication- in medicines R&D or therapy-specific information! 7
  8. 8. Audiences: advocacy leadersand the public at large EUPATI Certificate Training Programme Patient Ambassadors in committees, HTA agencies, industry, 100 regulatory bodies, academia etc patient Patient Journalists raising awareness Patient Trainers for patient communities and networks. advocates EUPATI Educational Toolbox 12.000 Educational tools for patient advocates (print, slide shows, patient eLearning, webinars, videos) for patient advocates advocates EUPATI Internet Library Patients & lay public at large, e.g. on specific aspects of the development process of medicines for patients with low 100.000 (health) literacy. individuals
  9. 9. Reflecting EU diversity: Languages• 7 most frequently spoken languages: English, French, German, Spanish, Polish, Russian, Italian• Serving 12 European countries: UK, Ireland, Malta, France, Luxemburg, the francophone Belgium, Switzerland, Germany, Austria, Spain, Italy and Poland, plus Russian-speaking population in CEE 9
  10. 10. Four leading pan-EU patientorganisations in a leadership role  European Patients‘ Forum  EUPATI Project Coordination ◦ >50 umbrella patient organisations. Through members of members, potential outreach to 150 million patients  European Genetic Alliance Network ◦ Linked with national and regional patient alliances in Germany, Eastern Europe, Italy, Netherlands, United Kingdom and Ireland, Sweden, Spain, Italy, Greece and Balkan countries  EURORDIS – Rare Diseases Europe ◦ Representing >550 rare disease organisations in >45 countries  European AIDS Treatment Group ◦ More than 100 members in over 30 countries. 10
  11. 11. Strong consortium & governance• Leading pan-EU patient umbrella groups• Strong impetus from key academic partners and research organisations• Industry expertise in medicines R&D• Advisory bodies & codes committed to ensure independence and good governance – EMA, Swissmedic, MHRA, BfArM – Key experts in bioethics, genetics, HTA, economics, evidence based med, patient advocacy
  12. 12. What we will have achieved by 2016• EUPATI platform fully loaded with training, education, information material in multiple languages• EUPATI Patient Ambassador, Patient Journalist, Train-the-Trainer Programme in place• Good practice guideline for patient involvement released• 2 pan-European conferences and 5 regional workshops performed. Expert network established. …first content available from 2014. 12
  13. 13. Get to know us on the Internet! Web: www.patientsacademy.eu Social Media: Twitter @eupatients E-Mail: Jan Geissler EUPATI Director jan@patientsacademy.eu
  14. 14. DisclaimerThe views and opinions expressed in the following PowerPoint slides arethose of the individual presenter and should not be attributed to DrugInformation Association, Inc. (“DIA”), its directors, officers, employees,volunteers, members, chapters, councils, Special Interest AreaCommunities or affiliates, or any organization with which the presenter isemployed or affiliated.These PowerPoint slides are the intellectual property of the individualpresenter and are protected under the copyright laws of the UnitedStates of America and other countries. Used by permission. All rightsreserved. Drug Information Association, DIA and DIA logo are registeredtrademarks or trademarks of Drug Information Association Inc. All othertrademarks are the property of their respective owners. 14

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