Start Up Central Workshop
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1 , Start Up Central Workshop Patients Partnering in Clinical Research 11 June 2009 Marivaux Hotel Congress & Seminar Centre Brussels, Belgium
2 Programme Committee Corinne Gaillard Melissa Hillier Alastair Kent Ingrid Klingmann Rodney Mitchell Cor Oosterwijk Tsveta Schyns Kim Wever Faculty Serge Braun Stephan Dressler Alastair Kent Ingrid Klingmann Rodney Mitchell Isabel Moulon Jennifer Newman Gerard Nguyen Cor Oosterwijk Start Up Central Workshop European Forum for Good Clinical Practice (EFGCP), Belgium Genetic Interest Group (GIG), United Kingdom Genetic Interest Group (GIG), United Kingdom European Forum for Good Clinical Practice (EFGCP), Belgium European Genetic Alliances Network (EGAN), United Kingdom Dutch Genetic Alliance (VSOP), PatientPartner Coordinator, The Netherlands European Genetic Alliances Network (EGAN), Austria Dutch Genetic Alliance (VSOP), The Netherlands Association française contre les myopathies (AFM), France European Aids Treatment Group (EATG) Genetic Interest Group (GIG), United Kingdom European Forum for Good Clinical Practice (EFGCP), Belgium European Genetic Alliances Network (EGAN), United Kingdom European Medicines Agency (EMEA) Medicines for Children Research Network (MCRN), United Kingdom Rett Syndrome Europe, France Dutch Genetic Alliance (VSOP), PatientPartner Coordinator, The Netherlands Khazal Paradis Genzyme, The Netherlands Sue Pavitt Clinical Trials Research Unit, University of Leeds, United Kingdom Tsveta Schyns European Genetic Alliances Network (EGAN), Austria Tomasz Szelagowski Federation of Polish Patients, Poland Marieke Voets van Meel Nephcure International, The Netherlands Kim Wever Dutch Genetic Alliance (VSOP), The Netherlands PP_11_Jun_2009_Draft_Prog_v1_ doc p. 2/6
3 Workshop Language The language of the Workshop will be English. Workshop Rationale When we think of the role of patients in clinical research, this might be limited to the thought of a patient being a subject in a clinical trial. However, patients and patient organisations may have much more to offer. By using their experiential knowledge, patients have a potential role as partners in clinical research. A partnership between patients and patient organisations and the other stakeholders e.g. pharmaceutical companies and clinical researchers, will create new paradigms from which not only the patient will benefit, but also the quality, quantity and effectiveness of clinical research. In the end, such partnerships will contribute to better, patientcentred health care. PatientPartner is a 3 year EU FP7 project investigating, enforcing and advising on the role of patient organisations in clinical trials. It is managed by the Dutch Genetic Alliance (VSOP), the European Forum for Good Clinical Practice (EFGCP), the European Genetic Alliances' Network (EGAN) and the Genetic Interest Group (GIG). The PatientPartner project s main goals are: to make an inventory of the needs of patient organisations regarding their involvement in clinical research; to identify and realise common points of action amongst all stakeholders through engaging in an active dialogue with patient organisations; to establish a European Network for Patients Partnering in Research (ENPCR) which will support the greater involvement of patient organisations in clinical research; the realisation of patient centred guiding tools and recommendations on how to create a successful partnership in the clinical trials context. With this European Start up workshop, PatientPartner kicks off its second project year. In its first year, PatientPartner identified existing examples of the involvement of patient organisations in clinical research on all possible levels, from being a research subject to being the driving force of a clinical trial. The project also researched the needs, wishes and opinions of patient organisations that are or wish to be partners in clinical research. The outcomes of this inventory will be presented during this first (out of five) European workshop, together with several best practices from the perspectives of the major stakeholders involved. Above all, this workshop has the intention to identify the existing possibilities and the existing hurdles to form successful partnerships between patient organisations and the other major stakeholders in the clinical research of the future. The results from this first workshop will form the basis for the dialogue between patient organisations and other stakeholders in the upcoming regional European workshops that will be held in the second part of 2009 in North West, Southern and Central Eastern Europe. In March 2010, at the final PatientPartner workshop, all ideas and recommendations from the regional workshops on partnership will be combined. In this final workshop, the dialogue between all stakeholders will be directed to the formulation of recommendations on how successful partnerships in clinical research can be achieved. PP_11_Jun_2009_Draft_Prog_v1_ doc p. 3/6
4 Investigators Inestigator Guide Literature search Best practices Interviews Start- Up Central Workshop Regional Workshop Central/East Europe Regional Workshop SouthernEurope Regional Workshop Nord-West Europe Recommandations Guide Policy makers Regulators FinalCentral Workshop Patient European Network of / Working Groups Region Definitions Central and Eastern Europe Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia + Albania, Belarus, Bosnia Herzegovina, Croatia, Macedonia, Moldova, Montenegro, Serbia, Ukraine Southern Europe Cyprus, France, Greece, Italy, Malta, Portugal, Spain + Andorra, Gibraltar, Monaco, San Marino, Turkey, Vatican Northern and Western Europe Austria, Belgium, Denmark, Finland, Germany, Ireland, Luxembourg, Sweden, The Netherlands, United Kingdom + Iceland, Liechtenstein, Norway, Switzerland PP_11_Jun_2009_Draft_Prog_v1_ doc p. 4/6
5 Agenda 08:15 Registration and Welcome Coffee 09:00 Welcome and Introduction to the PatientPartner Project Cor Oosterwijk, VSOP, PatientPartner Coordinator, The Netherlands Plenary Session 1 Best Practices of Patient Involvement in Clinical Trials Chairpersons: Serge Braun, AFM, France Cor Oosterwijk, VSOP, PatientPartner Coordinator, The Netherlands 09:15 Results of the PatientPartner survey: Inventory of the existing views, needs, practices and experiences of patients Kim Wever, VSOP, PatientPartner Project Officer, The Netherlands 09:40 Stakeholders viewpoints The Investigator s perspective Sue Pavitt, Clinical Trials Research Unit, University of Leeds, United Kingdom 10:00 The Industry s perspective Khazal Paradis, Genzyme, The Netherlands 10:20 The Patient s perspective Stephan Dressler, EATG, Germany 10:40 Discussion Coffee Break Plenary Session 2 How patient involvement can change the clinical trials of the future Chairpersons: Rodney Mitchell, EGAN, United Kingdom Khazal Paradis, Genzyme, The Netherlands 11:20 European Network of (ENPCR) Tsveta Schyns, EGAN, Austria 11:30 Data & biobanking and patient registries Serge Braun, AFM, France 11:45 Communication and training of the stakeholders as prerequisite for successful clinical trials Ingrid Klingmann, EFGCP, Belgium 12:00 Patients role in competent authorities Isabelle Moulon, EMEA 12:15 Clinical trials with children Jennifer Newman, MCRN, United Kingdom PP_11_Jun_2009_Draft_Prog_v1_ doc p. 5/6
6 12:30 Lunch Break out sessions Identifying Differences & Similarities Defining Topics for the PatientPartner Regional Workshops 13:30 Working Group 1: Central and Eastern Europe Chair: Tsveta Schyns, EGAN, Austria Rapporteur: Tomasz Szelagowski, Federation of Polish Patients, Poland Working Group 2: Southern Europe Chair: Alastair Kent, GIG, United Kingdom Rapporteur: Gerard Nguyen, Rett Syndrome Europe, France Working Group 3: North Western Europe Chair: Cor Oosterwijk, VSOP, PatientPartner Coordinator, The Netherlands Rapporteur: Marieke Voets van Meel, Nephcure International, The Netherlands 15:00 Coffee Break Plenary Session 3 Regional Strategies to Strengthen Patients Role as Driver of Clinical Research Chairpersons: Ingrid Klingmann, EFGCP, Belgium Alastair Kent, GIG, United Kingdom 15:20 Reports from the working groups 15:50 Open forum Working Groups Rapporteurs 16:20 Closing Remarks Alastair Kent, GIG, United Kingdom 16:30 End of the meeting PP_11_Jun_2009_Draft_Prog_v1_ doc p. 6/6
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