The First 2 Years of the European Medicines Agency's Policy on Access to Documents: Secret No Longer

Doshi P, Jefferson T. — Mon, 11 Mar 2013 00:00:00 GMT

On November 30, 2010, the regulatory agency for medications in Europe, the European Medicines Agency (EMA), announced a policy on access to “any document originated, received or held by the Agency.” The policy made a wide range of regulatory documents potentially accessible to anyone who asks for them, including clinical study reports. Documents are released without charge, primarily in PDF format, and made available via a web-based download. We used this policy and received 25 000 pages of previously unreleased clinical study reports on Roche's oseltamivir phosphate (Tamiflu) trials, all unredacted. This formed the basis of our recent Cochrane review on neuraminidase inhibitors. The release of such documents contrasts with the approach of the US Food and Drug Administration (FDA), which similarly has a freedom of information policy but treats industry-sponsored clinical trial data as confidential and trade secret, denying public release on the grounds that disclosure could cause competitive harm to original study sponsors. We sought to inform discussion of access to clinical trial data by describing how the EMA's policy is being used.

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

Steinbrook R. — Mon, 11 Mar 2013 00:00:00 GMT

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.

JAMA Internal Medicine: Global Health Topic Collection

The First 2 Years of the European Medicines Agency's Policy on Access to Documents: Secret No Longer

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