[Patients' associations and clinical research--academic and industrial].

Les associations de patients et la recherche clinique académique et industrielle

Philippe Amiel (1)

1 ECEVE (U1123 / UMR_S_1123) - Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables

The notion of "health democracy" was introduced as a core principle into the French health law in 2002. Accordingly, stronger individual rights were recognized to patients and, at the same time, patients' representatives have progressively served at all levels of the governance of health system. In clinical research, it is mandatory since 2004 that institutional review board include patient representatives (I). Patient associationsplay a role in clinical research in financing and/or helping to organize clinical trials. In addition, associations play a role in protecting patients from abusive research--as well as from being possibly not solicited as a subject in trials that could open access to medical innovation. There is no question that, with the support of associations, a patient with HIV or myopathy--eligible but who was not solicited--will obtain to participate in a trial of his or her choice (II). If the role of patients' association in health democracy has become both unquestionable and important, it is nevertheless limited. Patients may be disadvantaged if no combative association is committed on their disease. Patients' associations' role is no substitute to that of the State and the law-only able to devote equitable rights to individuals (III).

Mots clés: Biomedical research; Health care system; Democracy; Patients rights; Patient advocacy

Mots clés: Associations de patients; Droit des patients; Démocratie; Système de santé; Recherche biomédicale

Domaines: Santé publique et épidémiologie; Sociologie; Droit

Philippe Amiel. Les associations de patients et la recherche clinique académique et industrielle. Bulletin de l'Académie Nationale de Médecine, 2015, 199 (4-5), pp.589-96. ⟨hal-01340984⟩