European regulators see way forward for publication of full clinical trial data

A group of European regulators have set out a way forward for the publication of the results of clinical trials of authorized medicines. Their paper, titled Open clinical trial data for all? A view from regulators, was published this week in the journal PloS Medicines and was a response to an article in the same issue by Doshi et al, which called for open access to all clinical trial data so that independent re-analysis of the benefits and risks of medicines can be conducted.

The response, co-authored by the European Medicines Agency's senior medical officer Hans-Georg Eichler, its executive director Guido Rasi, and three other European regulators, examines the reasons for and against the open access of these data.

Clinical data should not be considered commercially confidential, they state