The European Commission, 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 (EU) of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).
The letter stresses that transparency and public access to clinical trial results, positive or negative, are fundamental for the protection and promotion of public health. The organisations insist transparency that also enhances scientific knowledge, helps advance clinical research and supports more efficient medicine development programmes.
Since July 2014, sponsors are required to post results within one year after the end of a clinical trial (six months for a paediatric trial). This information is also shared with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP).
As of April 2019, the EudraCT database included 27,093 completed trials. Of these, 18,432 should have had results posted, but sponsors had complied with publication requirements for only 68.2 per cent (12,577) of the trials.
The reporting compliance of non-commercial sponsors was much lower than for commercial sponsors, at 23.6 versus 77.2 per cent, respectively.
The letter is being disseminated to various stakeholders, with a particular goal to reach academic sponsors.