Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

Abstract

ObjectivesTo ascertain compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a tool for live ongoing audit of compliance.DesignRetrospective cohort study.SettingEUCTR.Participants7274 of 11 531 trials listed as completed on EUCTR and where results could be established as due.Main outcome measurePublication of results on EUCTR.ResultsOf 7274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results. Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% v 11.0%, adjusted odds ratio 23.2, 95% confidence interval 19.2 to 28.2); as were trials by a sponsor who conducted a large number of trials (77.9% v 18.4%, adjusted odds ratio 18.4, 15.3 to 22.1). More recent trials were more likely to report results (per year odds ratio 1.05, 95% confidence interval 1.03 to 1.07). Extensive evidence was found of errors, omissions, and contradictory entries in EUCTR data that prevented ascertainment of compliance for some trials.ConclusionsCompliance with the European Commission requirement for all trials to post results on to the EUCTR within 12 months of completion has been poor, with half of all trials non-compliant. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. Accessible and timely information on the compliance status of each individual trial and sponsor may help to improve reporting rates.

Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials

“…Legal regulations concerning dissemination of clinical trial results are similar in the EU and the USA. In general, there is a requirement both to prospectively register and to post basic information including summary results of clinical trials on a clinical trial register (EU Clinical Trial Register [EUCTR] and ClinicalTrials.gov for the EU and the USA, respectively) . The data about clinical trials contained in those registers are publicly available on the respective websites .…”

“…Studies with a noncommercial sponsor were substantially less likely to post results compared with those with a commercial sponsor. Moreover, the study revealed numerous errors, omissions and contradictory entries in EUCTR . So far, this has been the only study to evaluate the compliance with the Guideline 2012/C 302/03.…”

“…The largest of clinical trial registers—ClinicalTrials.gov—was established in 2000 and contains a range of information about registered trials including type of intervention, trial design, outcomes measured, funders, sponsors and principal investigator, as well as results . Over the last decade, the importance of clinical trial registers for dissemination of trial outcomes has substantially grown; in fact, posting summary results on a respective register is currently a legal requirement both in the European Union (EU) and the USA . However, the compliance with this requirement has been generally poor .…”

“…Over the last decade, the importance of clinical trial registers for dissemination of trial outcomes has substantially grown; in fact, posting summary results on a respective register is currently a legal requirement both in the European Union (EU) and the USA . However, the compliance with this requirement has been generally poor . Furthermore, the quality of registration of clinical trials is still not optimal and many trials are registered retrospectively, which may be associated with discrepancies in outcome reporting between registers and journal publications .…”

“Shocking” number of clinical trials are never reported, say MPs

“…Data on non-reporting of trial results came from evidence published in The BMJ this year by Ben Goldacre and colleagues at the Evidence-Based Medicine DataLab at the University of Oxford’s Nuffield Department of Primary Care Health Sciences 2. They identified 7274 trials where results were now due and found that only 49.5% had reported.…”