Important research on freedom of information requests for regulatory data
Peter Doshi and Tom Jefferson have published an article in Trials reporting a case series of 12 requests to the European Medicines Agency (EMA) for regulatory data. The requests were for 118,000 pages relating to 29 medicines and biologics. The requests included the 2011 request for Tamiflu data that enabled their Cochrane Review to begin to move beyond publications and consider the detailed clinical study reports that regulators routinely use to understand and assess trials.
Given the growing recognition of regulatory data as the key to unlocking reporting bias in the scientific literature, they report that using the EMA’s new system is more complex and convoluted than one might hope. It was found that release can take considerable time to occur and often only after a lengthy correspondence. Given the importance of EMA requests for research and significance for transparency, this article suggests ways in which the process could be made more efficient.
Access to clinical trial data from the European Medicines Agency in On Medicine blog
0043 – Agent of the no secrets service? in Oxford Science Blog