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European Clinical Trial Directive(Directive 2001/20/EC)
dr. Cees Smit (NPCF/EGAN)EPF Annual Meeting
May 19, Brussels
European Clinical Trial Directive
1998/1999• Concerns expressed by European Patient Organisations• Recommendation: one European research/registration file 2004 – 2006: Implementation at MS level2007 (Evaluation EU/EMEA October 3, 2007, London)• More paper work, bureaucracy• 1 Directive, 27 Member States Implementations• Less research, less academic research• Higher prices, higher insurance premiums, • Less research money/grants• Patients not represented in Research Ethic Committees
The current situation
• Numerous articles and case-studies have postulated that Directive 2001/20/EC, the ‘Clinical Trial Directive’ has failed to promote efficient clinical research in Europe and to better protect the study participants
• However, there are more causes for the decreasing clinical research activity in Europe (if so!) than the legal framework alone
• Consultation EC end 2009, response EPF
Response EPF January 19, 2010 (1)
• Questionnaire EC highly technical• The effectiveness of clinical trials throughout
the EU is of fundamental importance for EPF and its members.
• EPF and its members very active in this area:• So input drawn on evidence from Value+,• PatientPartner (VSOP, EGAN, EFGCP), Involve,
Respect, EMA/EPF, Europa Donna, IDF-EU
Response EPF January 19, 2010 (2)
• Meaningful patients’ involvement in clinical trials processes (Eurordis charter OD)
• Access to quality information at all stages• Informed consent in an accessible language• Clinical trials for paediatric patients• Transparancy regarding clinical trials across
EU incl. learning from trials that have failed• Access to treatment after the trial
Response EPF January 19, 2010 (3)
• Finally, EPF welcomes the Commission’s initiative to consult the public on the Directive
• EPF is committed to work with the Commission and other relevant stakeholders in translating the vision and the core issues outlined in their response into more effective, patient-centred EU legislation on clinical trials
Commissioner John Dalli
• Recently told the Parliament that the Clinical Trials Directive is going to be reopened, but it is not clear yet whether it will be a light revision of the text or a full revision of the text.
• A first draft is expected by Winter 2011
Drug development process
11 22 33 44 55 66 77 88 99 1010 1111 1212 1313 1414 1515 1616 1717 1818 1919 2020
fundamental pre-clinical research
Ph. 1Ph. 1
Phase 2Phase 2
Phase 3Phase 3
Phase 4Phase 4
Registration
clinical research
post marketing researchpost marketing research
effective patent-periodPatent request
launch product
End of patent
Years Ref: Jan Raaijmakers (2005, UU)Years Ref: Jan Raaijmakers (2005, UU)JR 2005
The theory: levels of patient participation in clinical research ref: www.patientpartner-europe.eu
19/04/23 9
Research subject
Information provider
Advisor
ReviewerReviewer
Co-researcherCo-researcher
Driving forceDriving force
19/04/23 10
Outcome PatientPartner survey
Co-researcher
Advisor
Information Provider
Research subject
Driving Force
Reviewer
Role of Patient Groups in Research and their Prioritiesfor the Future
Fabrizia BignamiEurordis Therapeutic Development Director
Rare Disease Day Workshop
Brussels, 1 March 2010
www.eurordis.org
37% of POs financially support research
Multisyst
Musculosk
Neuromusc
Haemato
Neurology
Ophthalmo
Oncology
Others
Dermato
Metabolic
Cardiovasc
Umbrella
>75%
60-75%
45-60%
30-45%
15-30%
<15%
Distribution by disease type Distribution by country
81 % Basic research
57% Therapeutics
56% Diagnosis
46% Human and Social Science
19% Research infrastructures
54% Epidemiology / Natural history of the disease
24% Assistance technologies / Daily life
What kind of research do patients fund?
Development costs of a new drug
The ‘productivity’ gap
• Input: $ 50 – 80 miljard R&D spending/year• Output: 5 – 6 ‘first in class’ drugs/year• Payers/HTA adding C + E criteria further
reduce the number of products that will reach the patient
(Hans-Georg Eichler, TI Pharma, April 28, 2010)
