The european medicines agency and the brave new world of access to clinical trial data
Cet article analyse la politique de l'Agence Européenne des Médicaments en matière d'accès aux données des essais cliniques ayant servi à une autorisation de mise sur le marché
As of January 2014, the European Medicines Agency (EMA) will publish clinical trial data for the medications it considers for approval. After the marketing authorization process is complete, researchers and others who are independent of the sponsors of studies, the authors of journal reports, and regulatory agencies should be able to review complete study information, including anonymized data at the patient level, reanalyze the data, and conduct new analyses. If the EMA fulfills its promises, a new era of clinical trial data as a public good will begin. Data held by the agency will be available regardless of whether a trial is sponsored by industry, a medical research agency, or a foundation or initiated by investigators.
Archives of Internal Medicine , commentaire en libre accès, 2011