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).
Clinical trials are the key drivers of medical innovation and progress in patient-care and disease prevention. A sufficient level of scrutiny and transparency in clinical trials is essential to protect public health and to foster innovation in the medical research field. Transparency assures trial subjects that their voluntary participation in clinical trials is useful and that the results have been collated and reported for the benefit of all. In addition, for those medicines which are placed on the market or used in further clinical trials, it allows patients and healthcare professionals, or any other citizen, to find out more information about medicines they might be taking or prescribing. It also enhances scientific knowledge and helps to advance clinical research and support more efficient medicine development programmes.
In order to achieve this, all relevant protocol and results related information regarding clinical trials that are authorised in the EU needs to be kept in the EU Clinical Trials Database (EudraCT) and publicly available through the EU Clinical Trials Register. This is particularly true for the timely publication of clinical trial result summaries, including information on the objectives, design and main conclusions and results of a given study. Comprehensive access to summary results has been regarded an essential feature for clinical trials in order to allow patients, practitioners, policy makers and other economic operators to make well-informed decisions about health-care and medical research.
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.
As of April 2019, the EudraCT database included 57,687 clinical trials in total, 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 68.2% (12,577) of the trials, however results were still lacking for 31.8% of them (5,855).
Underreporting and selective reporting of trials with positive outcome may lead to potentially avoidable redundancies in the conduct of clinical trials and compromise the economic and scientific efficiency of clinical research. In addition, unreported clinical trials with unfavourable outcome can have negative public health implications. Academic and other non-commercial sponsors are particularly encouraged to post the results of their trials in EudraCT in order to maximise their valuable contribution to meet public health needs and to advance clinical research especially where commercial interest is weaker.
In order to improve compliance on the posting of results, the the European Commission, the European Medicines Agency and the Heads of Medicines Agencies remind all sponsors about their obligation for the reporting of clinical trial summaries in Clinical Trials Database.