Objectives In February 2019, the Chair of the House of Commons’ Science and Technology Committee sent a letter to forty universities warning them to upload their backlog of missing summary results from clinical trials listed on EUCTR by the end of summer 2019. The objective of the present study is to
Track the progress of UK universities in the process of uploading their backlog of overdue summary results on EUCTR and clinicaltrials.gov
Elucidate if UK universities take steps towards both prospective and retrospective trial registration.
Method We selected the 25 UK universities receiving most UK Medical Research Council funding in 2015-2016 and included two universities that were part of previous UAEM Global Health Report Cards. We filed FOIs in June 2018 to obtain universities’ institutional policies regarding clinical trial registration and prospective and retrospective summary results posting, assessing them based on predetermined criteria taken from WHO and EU guidelines. We filed further FOIs due in May 2019 to track progress.
To evaluate reporting performance we utilised the EBM Data Lab’s EU Trials Tracker and a python script coded by one of the authors (YNL) to extract key information on results posting from clinicaltrials.gov(https://github.com/LeeSean96/GlobalHealthRanking?fbclid=IwAR00rTbendLByaqoPNhUZRrLo_iJlYib_gbtce9QjW9x3gX47-OKcaMrKxQ). A sample of results was manually checked for accuracy. We will collect data from the European and American registries in April&June make comparisons with results collected before the Committee’s letter in January 2019.
Results We identified 27 universities in the UK that together received £343,742,000 in research grants from the Medical Research Council in the year 2015–2016.
Firstly, significant gaps of university’s institutional policies regarding clinical trial registration and summary result posting persist: i.e. 25/27 universities do not have a publicly available policy requiring university sponsored clinical trials to report summary results.
Secondly, preliminary results from January 2019 show that the reporting performance of UK universities in the European Registry increased from 51% to 62% [Nov:120/234; Jan: 158/254]. However, no such progress is seen on the American Registry, where still 97% of due trials are missing summary result posting [Jan:1575/1624].
Conclusions Preliminary results for January 2019 show that some universities in particular are on the right track to upload summary results of clinical trials, although progress is mostly limited to the EU registry. This is most likely due to increased public and political pressure to comply with EU guidelines regarding clinical trials. Our final results will clarify whether a wider set of universities will enhance clinical trial summary results posting on both key registries or if progress remains to be propelled by a smaller number of universities only. We will also discuss if universities are taking active steps towards both prospective and retrospective summary result posting by analyzing FOI requests due in May 2019. Further research should be conducted on the quality and completeness of summary result postings and the potential overlap of universities’ trial registrations on the European and American databases.
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