Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).
Transparency and public access to clinical trial results assures trial subjects that their participation is useful and that the results have been collated and reported for the benefit of all. It also allows people to find out more information about medicines they might be taking or prescribing.
Transparency also enhances scientific knowledge and helps to advance clinical research and support more efficient medicine development programmes.
The reporting compliance of non-commercial sponsors was much lower than for commercial sponsors, with 23.6 percent of results posted for non-commercial sponsors versus 77.2 percent for commercial sponsors, therefore EU authorities are taking various steps to ensure sponsors are aware of their obligations and can act on them.
One of these steps is this letter to stakeholders regarding the requirements to provide results for authorised clinical trials in EudraCT, co-signed by Anne Bucher, Director General of the EC’s DG Health and Food Safety, Guido Rasi, Executive Director of EMA, and Thomas Senderovitz, Chair of the HMA Management Group. It will be disseminated to various stakeholder groups, with a goal in particular to reach academic sponsors.
Since July 2014, sponsors are required to post results within one year after the end of a clinical trial (or six months for a paediatric trial), and it is the responsibility of sponsors to ensure that the protocol information and results of all clinical trials is submitted in EudraCT.
The EudraCT database included 57,687 clinical trials as of April 2019, out of which 27,093 were completed. Out of these completed trials, 18,432 should have had results posted; sponsors were in compliance with the publication requirements for just 68.2 percent (12,577) of the trials.