EMA to discuss proactive release of clinical data

EMA will hold a workshop in November to discuss how to implement the agency's plan to proactively release clinical data for approved drugs. Under EMA's transparency initiative, the agency only provides data upon request. An EMA spokesperson said the workshop is the first step in determining the extent of data that will be made public, as well as when data will be made public, and who will receive access. Details of the workshop, including the date, time and participants, are still being finalized. The spokesperson said more information will be available "shortly."

In April, a group of European regulators -- including EMA's Senior Medical Officer Hans-Georg Eichler and Executive Director Guido Rasi -- published a paper in PLoS Medicine warning of the risks associated with open access to trial data and calling for debate to establish data transparency standards. In the same PLoS issue, Johns Hopkins School of Medicine researcher Peter Doshi argued in a second paper that full clinical trial reports for authorized drugs should be made publicly available to enable independent re-analysis of a drug's benefits and risks (see BioCentury Extra, April 11). ...