March 2022: Delay in Publishing Clinical Data by EMA – A TranspariMED Report

An article “Where are the Clinical Study Reports we were promised?” has been published on March 31, 2022, on TranspariMED.

It informs that years ago, European Medicines Agency (EMA) promised to publish the Clinical Study Reports (CSRs) but as per new research – Substantial delays in clinical data published by the European Medicines Agency – a cross sectional study, there has been a delay in publishing the clinical study data by EMA.

Clinical study data includes clinical overviews, clinical summaries, clinical study reports, protocols, protocol amendments, sample case report forms, documentation of statistical methods, and individual patient data.

It mentions that the target for releasing the CSRs was within 60-150 days, but evidently, the agency took more than a year and only less than 2% of CSRs were released on time before EMA suspended the release of CSRs in 2018. It has been over three years and yet EMA has not announced the relaunch of this initiative. An exception was made for releasing CSRs for Covid-19 treatment and vaccines.

A total of 148 clinical data packages containing 1,0o5 clinical trials were reviewed by the authors of this new research. They suggest EMA to resume the publication of the clinical data according to Policy 0070, on priority and reduce the time to the publication of all data. It also provides information on Policy 0070.