Patient Groups as Research Partners: a changing perspective. Dr. Cees Smit, EGAN/VSOP TCPM Policy Track ErasmusMC, November 7, 2013
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1 Patient Groups as Research Partners: a changing perspective Dr. Cees Smit, EGAN/VSOP TCPM Policy Track ErasmusMC, November 7, 2013
2 Unmet medical needs Unmet medical needs are the driving force for patient groups to become active in medical research
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5 Proportion of patients Age-distribution severe haemophilia (n=338) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Year >40 years years years years 0-10 years Mauser et al, Van Creveldclinic, Utrecht, 2010, personal communication
6 % of patients Age-distribution HIV % 80% 60% 40% >= <30 20% 0% Stichting HIV Monitoring database, AMC, NL, 2009
7 The patient in 40 years Patiënt 1.0 Patiënt 2.0 Patiënt 3.0 Information, education Peer support Lobbying for their interests Internet, social media, Wiki s, Patientslikeme, SWAN UK Cooperation researchers, patients and companies Driving force: Unmet medical needs
8 Dutch patient groups Micro About disease-specific patient groups Meso Large disease-specific umbrella groups (diabetes, cancer, rheuma & arthritis, heart & vascular diseases, COPD, neuromusculair diseases and genetic/rare diseases) Macro The 4 (NPCF, CG-Raad, VG, GGZ, & PGOSupp.)
9 Worldwide patientmovement IAPO Int. Alliance of Patient Organizations EPF European Patients Forum Eurordis EU organization for Rare Diseases ECPC EU Cancer Patient Coalition EAPM EU Alliance for Pers. Medicine EGAN EU Genetic Alliance Network Important Eu Commission/Parliament & contacts: European Medicine Agency
10 Eerste boek over Nederlandse patiëntenbeweging Harderwijk, 24 februari 2012 Patiëntenorganisaties zouden meer betrokken moeten zijn bij medischwetenschappelijk onderzoek. Zo ontstaat voor alle partijen patiënten en wetenschap een win-winsituatie. Dit stelt Cees Smit in Een nieuwe horizon: de toekomst van de patiëntenbeweging in Nederland dat morgen verschijnt. Nooit eerder is dit onderwerp in boekvorm beschreven.
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12 The drug development process Patent request End of patent effective patent-period clinical research fundamental pre-clinical research Ph. 1 Phase 2 Phase 3 Phase 4 Registration post marketing research launch product Years JR 2005 Ref: Jan Raaijmakers (2005, UU)
13 Duw or Push model
14 Trek or Pull model
15 Innovative power patients To bring together patients and their body material (DNA, MSS) Sharing of data for research and the organization of cooperation (CF/EuroBiobank) Fundraising for biobanks and research (gene therapy), also for the long term (AFM, Généthon, DPP, Alpe du Hu Zes) (Ref.: Van der Valk & Smit, NTvG, mei 2011)
16 Roadblocks (1) For Patient Registries / Biobanks as a Research Infrastructure Tool we need appropriate long-term finance structures Good examples: HIV, HOVON, CF For example: by a percentage of a DBC/DOT!
17 Roadblocks (2) The new EU Data Protection Regulation tends to ignore the negative effect the new Regulation could have on scientific and medical research A viable alternative could be to have a separate legislation specific to data protection in the areas of health and medical research. A precedent: Directive 2006/123/EC (the Bolkestein Directive on services)
18 Roadblocks (3) Registration & Reimbursement needs of n = 1 products instead of n = needs rethinking (a paradigm shift) The same for therapeutics & diagnostics The rare disease example: the need for EUwide databases and procedures
19 Roadblocks (4) Patients wants faster access to medicines, but New EU/Dutch regulation animal research New EU/Dutch clinical trial regulation New EMA procedures on transparency New EU Diagnostic regulation Growth in HTA/KEA s Makes EU/Dutch research more and more expensive and less accessible! Need to change!
20 Main message Patient groups want to be research partners in fullfilling unmet medical needs There are more and more examples where they actively contribute They fully recognize the administrative hurdles and want to solve them
21 For more information Dr. Cees Smit
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