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).
The letter emphasises the importance of transparency and public access to clinical trial results, regardless of outcome, as fundamental in the protection and promotion of public health. Additionally, the letter notes that it is the responsibility of sponsors to ensure that protocol information and results of all clinical trials are submitted in EudraCT; this information is publicly available through the EU Clinical Trials Register (EU CTR). 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). This information is also shared with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) of which EU CTR is a primary registry.
Analysis showed that in EudraCT, the reporting compliance of non-commercial sponsors (e.g. academia) was much lower than for commercial sponsors (i.e. companies), with 23.6% of results posted for non-commercial sponsors vs 77.2% for commercial sponsors. Academic sponsors or smaller companies often lack awareness or incentives to post clinical results, therefore EU authorities are taking various steps to ensure sponsors are aware of their obligations and can act on them.
The letter to stakeholders is 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 specific focus on ensuring it reaches academic sponsors. The full letter to stakeholders can be found here: https://www.ema.europa.eu/en/documents/other/joint-letter-european-commission-ema-hma-stakeholders-regarding-requirements-provide-results_en.pdf
