The European Medicines Agency and the Brave New World of Access to Clinical Trial Data

摘要

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.