Community participation in clinical trials in the context of universal health insurance and persisting inequities François Berdougo-Le Blanc, TRT-5, Paris, France Community Participation in HIV Related Clinical Research XVII International Aids Conference Mexico City August 2008

Issues « Ensure that people living with HIV are included in the design of ethical research for new prevention technologies and the development of treatments. » (The GIPA, UNAIDS Policy brief, march 2007) How to make the objectives of science and the objectives of the research participants match? Does access to care impact negatively on research by excluding the participation of certain populations? Does community have the responsibility to bring issues to the research agenda? Does community participation in research policy allow it to be better tailored to people needs? Is the collaboration between researchers and community an assurance for quality research?

Who are we? TRT-5 : « Treatments & Therapeutic Research » A coalition of eight French HIV/AIDS organisations, i.e. the French Community Advisory Board Founded in 1992 in the context of a medical and treatment emergency situation for people with HIV and AIDS Two main objectives: promote the needs of PLHAs in the areas of therapeutic research and standards of care & facilitate the dissemination amongst PHLAs of up to date information on treatments and clinical research results Our work is focused on therapeutic research and does not concern all the biomedical research regarding HIV/AIDS.

Summary How is the community, through TRT-5, involved in clinical research on HIV/AIDS development in France ? How do communities directly contribute in the design of studies? What are our main concerns related to PLHA’s involvment in research and how do we implement them? What are the limits to PLHA’s involvment in research in France ? How can we further our participation in research design ?

Community involvment in French clinical research Community participation depends on the promotors’ good will A close partnership between TRT-5 and ANRS (National Agency for Research on AIDS and viral hepatitis):  participation in Scientific council, working groups on research direction and animation, scientific committees and Data safety monitoring boards (DSMB) trials A limit: the cooperation with the industry research promotors  participation in some DSMBs

Which are our perspective on research? « In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society. » (5th article of the Declaration of Helsinki, World medical association)  i.e. our mandate is to promote the progress of science for the benefit of the whole society and especially the PLHAs  but also to safeguard the interests of the participants engaged in research, who are also PLHAs… We can’t sacrifice today research participants for the future benefit of society  our job is to make these objectives match together

Which criteria do we apply to review trials protocols? Our two main concerns: the scientific relevance and interest of the research & the safety of research participants To ensure a positive benefit-risk balance  to deliver a « win-win » approach in research: no additional risk or internal compensation Two examples: a new treatment strategies trial for people whose treatment is failing & the CCR5 antagonists case Is it because of the French context of universal access to healthcare that we can focus on research participants’ security?

How do we try to reach this compromise? No recipe or universal and definitive evaluation form Compromise is a process, reached through permanent and repeated dialogue between researchers and community  the quality of research will depend on the quality of this compromise The dialogue within the community: TRT-5 as a coalition

Is it easy to come up to a compromise with researchers? No, not always… Why can dialogue freeze at some point ? Because the position and interests of researchers and activists are fundamentaly different Because of the limits faced by researchers and activists. Most of the time, we succeed in overcoming these obstacles What about industry promoted research?

The limits to the PLHAs’ participation into clinical research in France Linked to the context of access to care and also to the social and political context In France, people without health insurance, and especially some migrants, are legally excluded from enrolment in clinical trials in order to avoid what would be considered undue inducement There are populations which are excluded from research, even if the HIV/AIDS field does a little bit better than others : women, drug users, transgenders etc.

The limits to the community involvment into research policy in France Does this framework support the « building together » of the community and research agenda? Putting community issues on the researchers agenda The « building together » model depends on how the researchers and promotors consider the dialogue with us as a part of the research development

Next steps To continue to overcome the obstacles we face regarding community involvment To improve The more research respects ethics and its participants’protection, the better she will be From the « community participation into research » to a « built together research » model The benefits : to include excluded groups of population ; to make research more tailored to PLHAs needs ; to address community issues

TRT-5 Group Franck Barbier, Elise Bourgeois-Fisson, Emmanuel Cook, Miguel De Melo, Caroline Gasiglia,Fabien Giraudeau, Christian Huchet, Marek Korzec, Annie Le Palec, Marianne L’Henaff, Hicham M’Ghafri, Maryvonne Molina, Guy Molinier, Fabrice Pilorgé, Georges Point, Eugène Rayess, Michel Repellin, Frank Rodenbourg, Réjane Zio, Corinne Taéron, Aurélie Verny, Jean-Michel Vimond Meet the TRT-5 Scientific Garden, Global Village Thursday 7th, 12h30-14h Special thanks to Marie de Cenival (Sidaction, Paris, France)