Reporting of Clinical Trial Results by Sponsors - Joint Letter of EC, EMA and HMA
In a joint letter issued yesterday, the European Commission, European Medicines Agency and Heads of Medicines Agencies remind all sponsors of clinical trials conducted in the EU of their obligation to make summaries of results of concluded clinical trials publicly available in the EU Clinical Trials Database (EudraCT).
Sponsors are expected to post results within one year (or six months in the case of paediatric trials) of the end of the trial. This will not change under the Clinical Trials Regulation (Regulation (EU) No 536/2014). According to the letter, 77.2% of the commercial sponsors comply with their reporting obligations. In contrast, reporting compliance by non-commercial sponsors is much lower and amounts to barely 23.6%. Therefore, it seems that the letter is addressed in the first place to academia and other non-commercial sponsors.
The letter is part of a broader campaign to increase sponsors’ awareness of their reporting obligations.
We attach for your perusal a copy of the letter and the related press release.