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

AbstractClinical 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 onClinicalTrials.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 tri als 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 inclu ded in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year o...
Source: Trials - Category: Research Source Type: clinical trials