The board at the European Medicines Agency has postponed formal adoption of its much-criticised policy on the publication of clinical trial data.
The policy was expected to be finalised in the next few days but has now been pushed back to the EMA’s board meeting on October 2. The agency says that “further clarifications on wording and practical arrangements” will be discussed by board members, “who have confirmed their general support to the overall aims and objectives of the policy”.
The latter include the “more user-friendly amendments” proposed by EMA executive director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes. That change was made after criticism from the German cost watchdog IQWiG, the AllTrials campaign, the BMJ, the Cochrane Collaboration and many others about proposals which would just allow ‘on-screen only’ viewing of redacted documents.
The EMA says that board members “have offered additional valuable contributions which will now be considered and addressed in the next few weeks”, saying that it welcomes “this additional round of joint reflections and respects all opinions”. The agency adds that in the last year, it has “attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information”.
