title: Active involvement of patients in drug research, evaluation, and commercialization: European perspective.
abstract: Patients' organizations intervene more and more often in clinical research and the evaluation of medicinal products. Examples of patients' involvement in the initiation, design, recruitment, conduct, and information of clinical trials were only anecdotal until the late 80s. Prior to this date, some rare experiences were reported. At the beginning of the 80s, the AIDS epidemic certainly changed the relation between clinical research and patients, and mechanisms that drove these changes are explained. AIDS activism focused its medical activities to the following domains: (1) to accelerate access to promising new drugs and (2) to contribute to ethical clinical research. The European Medicinal Evaluation Agency (EMEA) created in 1995 offered the opportunity to simplify discussions between European Union regulatory authorities and patients' representatives: a single interlocutor now exists. Interactions between EMEA and patients' representatives vary: they can be more or less structured. Whether intrusion of patients and their representatives in clinical research and pharmaceutical product development had an impact was explored by social sciences researchers. Conclusions are mitigated.
authors.affiliation: European Organisation for Rare Diseases (EURORDIS), Paris, France. francois.houyez@eurordis.org
authors.forename: François
authors.initials: F
authors.lastname: Houyez
mesh_terms: D035843:Biomedical Research; D011307:Drug Prescriptions; D005060:Europe; D006801:Humans; D010344:Patient Advocacy