Le TRT-5, avec Act Up-Paris, présente deux abstracts à Toronto qui mettent en perspective le travail réalisé par le groupe sur deux importants dossiers :
- la transposition de la directive européenne sur les essais cliniques en droit français,
- le débat éthique sur les essais de phase II des inhibiteurs du CCR5.
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Influencing legislative processes and policy development in order to improve research ethics
Référence de l’abstract : TUAE0305
Présentation orale le mardi 15 août à 17 H 15 (Salle de session 12) par Hugues Fischer
- Patient participation in trial ethics advisory boards
- Power of TEAB to create trial data safety monitoring board
- Power of TEAB to amend trial consent forms
- Written commitments to standard-of-care for ex-participants
- Compulsory disclosure of trial protocols to patient organizations
In many countries the HIV/AIDS movement is organised around Community Advisory Boards (CAB) to deal with issues such as, inter alies, protection of participants in domestic clinical trials. How can CABs influence legislative processes and policy development in order to improve research ethics for PLWH&A at the domestic level ?
At the occasion of a European Union-mandated reform of the French legislation on research ethics, Act Up-Paris, as a member of the French CAB (TRT-5), engaged in legislative lobbying which won, inter alies : compulsory disclosure of trial protocols to patient organizations ; patient participation in Trial Advisory Boards (TAB) tasked with vetting and monitoring clinical trials ; power to TABs to amend consent forms ; written standard-of-care commitments for participants who leave trials.
This paper will present the specific intelligence gathering strategies deployed to identify the key decision-makers in each parliamentary group, and to recruit a qualified Member of Parliament in both Lower and Higher House to be our champion. We will also present a system which was put in place for monitoring in quasi-real time objections to our requests from Members of Parliament, to adapt our lobby documents, and to pressure the Health Ministry against opposing our amendments.
Lessons learned :
By engaging in legislative lobbying on Parliament, the CAB a) generated unprecedented research ethics outcomes not only for HIV but for all of medicine, and b) established a sustainable relationship with health authorities of consultation on all legislative and regulatory reform impacting ethics, care and health coverage.
where not existing yet, IAC participants should support the creation and funding of national CABs ; existing CABs should seize relevant legislative opportunities to engage in more formalized forms of advocacy on legislative and executive branches, for instance along the lines delineated in the model above ; doing this can generate advocacy progress well above and beyond initial scope.
Responsibilities of state, community and private sector on research ethics policy : looking back on recent CCR5 antagonist trials
Références de l’abstract : WEKC101
Présentation orale le mercredi à 12 H 45 (lieu : Key Challenge Area 1) par Hugues Fischer
The early years of the fight against AIDS saw a redefinition of roles and responsibilities
between state, civil society and private sector on research priorities and research ethics. Yet, though greatly improved, the resulting compromise system created for ensuring appropriate protection of research participants is not perfect. This paper will explore activities and changes needed to reach a higher level of protection assurance for clinical research participants.
In November 2004 the French Community Advisory Board TRT5, of which Act Up-Paris is a member, became aware of participant safety issues with certain phase III CCR5 antagonist trials
about to launch in France. After initial discussions of the problem with first industry, then ethics committees, and finally regulators, the French CAB brought the matter to the attention of the National AIDS Council and the National Agency for AIDS Research. This paper will delineate the method employed to help these authorities come out publicly, by press statement, in support of our concerns for participants’ safety. Act Up-Paris has since then become the only member from outside North America in the CCR5 Antagonist Working Group of the Forum for Collaborative HIV Research in Washington, DC. Based on this experience, this paper will conclude with a reflection on the steps which need to be taken next for a more constructive collaboration between industry, ethics committees, regulators and community with a view to ensuring safety of research participants.
Lessons learned :
Industry/community discussion frameworks, ethics committees and drug regulators do not constitute a perfect system : the vigilance and mobilization of CBOs is still much needed. A more constructive collaboration between industry, ethics committees, regulators and community with a new view to ensuring safety of research participants is possible.
Governments should launch national consultations with community and ethics committees on areas for improvement of research participants protection frameworks.