Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Abstract

Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017–2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry (ClinicalTrials.gov). Firstly, we developed and evaluated a novel automated tracking tool (clinical-trials-tracker.com) for clinical trials registered on ClinicalTrials.gov. This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov. The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov: (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions’ reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future.

Assessment of clinical trial protocols for pathology content using the SPIRIT‐Path guidelines highlights areas for improvement

“…Some trials were registered on both sites and in some of these cases the full protocol was available on one site but not the other, or there was conflicting information regarding protocol versions, recruitment figures, and overall trial status (in set-up, open, closed, follow-up). Such discrepancies in trial registry information have been reported previously [36][37][38]. Some trials did not have a full protocol deposited on the registry but had links to documents on a study-specific website.…”

Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register

“…The hypothesis that political engagement drove the increase in CTIMP reporting performance on the EU Clinical Trial Register is supported by data showing that UK universities during the same time period did not extend their reporting efforts to other types of clinical trials listed on different trial registries; we found in October 2020 that only 10.2% of trials sponsored by UK universities had reported tabular summary results on the US-based ClinicalTrials.gov registry. 11 The committee’s letter only referred to CTIMPs, so universities largely focused their efforts on these trials only; also there is no regulatory requirement to upload the results of non-CTIMPs onto trial registries.…”

“…All CTIMPs conducted in the European Union must register on the EU Clinical Trial Register and upload their summary results within 12 months of completion. 4,8 In the past 3 years, we have evaluated clinical trial policies of UK universities, tracking their clinical trial registration and reporting policies as well as their reporting performance on the EU Clinical Trial Register and the American ClinicalTrials.gov trial registry [9][10][11] . This took place within the framework of the Universities Allied for Essential Medicines UK's Global Health Report Cards, 12 which evaluate the policies and performance of universities in the United Kingdom with regard to global health equity.…”

“…We have reported universities’ evolution of reporting performance for clinical trials registered on the ClinicalTrials.gov registry elsewhere. 11 …”

Major UK non-commercial sponsors’ efforts to reduce research waste: a mixed methods study

“…2 However, previous research indicates that many institutions' efforts to improve trial reporting did not extend to other types of trials listed on other trial registries. 3 The UK's national #MakeItPublic strategy now aims to ensure that going forward, all clinical trials involving UK patients will make their results public, but the strategy's scope does not extend retrospectively to older legacy trials. 4 Previous studies have found that in the absence of any external intervention, the results of very few trials that remain unpublished after 5 years will ever be made public.…”