clinical trials on trial the patient perspective wim vandevelde european aids treatment group (eatg)...
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Clinical Trials on Trial The Patient Perspective
Wim Vandevelde
European AIDS Treatment Group (EATG)
HAI Europe Open Seminar - November 21st 2008 - Berlin
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History of AIDS activism
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1988 FDA demo
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1990 NIH demo
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AIDS treatment activism - USA
participate in design of clinical trials
patient reps on committees at NIH, IRBs
FDA public hearings
new regulations for accelerated approval surrogate markers: CD4, VL
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1996 HAART
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GIPA
Greater Involvement of People with Aids
Meaningful involvement of PLWHA in all prevention, treatment, care and support decisions – strategy and policy design, funding, implementation and evaluation – will provide effective actions in controlling the epidemic.
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UNGASS Declaration of Commitment on HIV/AIDS
27 June 2001. Commitment #74: … ensure that all research protocols for the investigation of HIV related treatment, including anti-retroviral therapies and vaccines, based on international guidelines and best practices, are evaluated by independent committees of ethics, in which persons living with HIV/AIDS and caregivers for anti-retroviral therapy participate;
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UNAIDS GIPA Policy brief
« Ensure that people living with HIV are included in the design of ethical research for new prevention technologies and the development of treatments.» (March 2007)
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Denver PWA statement
We condemn attempts to label us as "victims," a term which implies defeat, and we are only occasionally "patients," a term which implies passivity, helplessness, and dependence upon the care of others. We are "People With AIDS."
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Meanwhile in Europe
1992: European AIDS Treatment Group (EATG)
Deutsche AIDS Hilfe – Actions Traitements – Abraço –Act-Up Paris – AIDES – Nadir – Lila – gTt – NAM – I-Base – TRT-5 – Sensoa – GAT – Synthesis – …
European Community Advisory Board (ECAB)
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European AIDS Treatment Group Mission statement
To achieve the fastest possible access to state of the art medical products and devices, and diagnostic tests that prevent or treat HIV infection or improve the quality of life for people living with HIV, or at risk of HIV infection.
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European AIDS Treatment Group
Policy Working Group
Capacity-building (advocacy and treatment literacy)
ECAB: Science & Community involvement
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ECAB – science & community
Interactions with researchers and scientists (Networks of Excellence, input in scientific conferences, treatment guidelines)
with pharma (drug development, CT design, community watchdog on AEs, DSMB, Informed Consent)
with regulatory agencies (EMEA, national regulators)
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ECAB – EMEA
EMEA Patients’ and Consumers’ Organisations Working Party
Package Leaflets/EPAR summaries: mandatory reviews on legibility, simplification
Guidelines on the Clinical Development for the Treatment of HIV, HCV
Scientific Advisory Group (SAG)
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Rx activists & CT:Goals
1. Safeguard the health and rights of trial participants 2. Ensure:
the fairness and transparency of the studies the enrolment of all population groups the rapid and transparent registration process for HIV
medication the early access to investigational drugs
3. Increase knowledge and information on investigational drugs and new medicines
4. Treatment information and counselling
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Safeguard the health and rights of trial participants
« In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests. »
(Art.6 Declaration of Helsinki, WMA Oct. 2008)
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Nothing about Us, Without Us
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Acknowledgements
Pedro Silvério Marques, Luís Mendão (EATG)
François Berdougo-Le Blanc (TRT-5)
Thank You!
[email protected] www.eatg.org