Only 2% of a cohort of clinical trials sponsored by four UK universities have posted summary results on Clinicaltrials.gov, an analysis of the world’s largest clinical trial registry shows. Out of 196 clinical trials whose primary completion date lies more than one year in the past, only 4 trials have posted summary results. The other 192 clinical trials are still lacking summary results.
The findings, which have yet to be verified with the universities involved, highlight the need for the UK government to ensure that universities meet their ethical, scientific and (sometimes) legal and regulatory duties to post all trial results. A parliamentary committee is currently drawing up recommendations for the government in this regard.
Unless universities post the missing trial results soon, they may be lost forever and turn into research waste because over time, the researchers who ran the trials retire and old data sets get lost.
While clinical trials typically cost millions to run, uploading summary results costs less than £2,000. Failure to publish clinical trial results contributes to the $85 billion in medical research waste that are being generated every year. Many university trials are publicly funded.
Global best practices developed by the World Health Organization and endorsed by numerous other bodies clearly state that the posting of summary results onto trial registries should occur within twelve months of the primary completion point of a clinical trial, regardless of whether this is required by law or not, and regardless of whether trial results have already been, or will be, published in academic journals. Medical journal editors have assured researchers that summary results posted onto registries will not prejudice subsequent acceptance for publication by an academic journal.
Later this year, the UK branch of Universities Allied for Essential Medicines (UAEM) with support from TranspariMED will use the same methodology to generate data on the Clinicaltrials.gov clinical trial reporting performance of several dozen leading UK universities. This and other clinical trial transparency metrics will contribute to university's overall position in UAEM's forthcoming 2018 UK Global Health Ranking. More information on the forthcoming ranking and its transparency component can be found here.
Brief note on methodology
The cohort consists of all interventional clinical trials sponsored by four UK universities – Birmingham, Leeds, Liverpool and Nottingham – that were registered on Clinicaltrials.gov as of 26 March 2018.
“Sean” Yi Nian Lee, a third year Physics and Molecular Cell Biology student at University College London who is an activist with Universities Allied for Essential Medicines, downloaded the data and checked trials’ primary completion dates and results posting status using an Excel pivot table. Out of a total of 335 trials, 190 had an (estimated or actual) primary completion date that lay more than twelve months in the past, and a further 6 trials stated no primary completion date at all, yielding 196 trials that should have posted results according to WHO best practices. Only 4 of these trials, just over 2%, have posted summary results. A further 139 trials are still ongoing or appear to have not yet passed the twelve-month timeline. Till Bruckner from TranspariMED supported the design of the pivot table and manually checked a sample of results.
TranspariMED will now contact the four universities whose trials were analysed in order to allow them to verify the accuracy of the data. Later this month, we will release the complete data set, and a breakdown of each university’s performance, together with universities’ responses.
The methodology’s focus on adherence to global best practices – rather than compliance with legal or regulatory requirements – is fully aligned with the existing policy positions of the World Health Organization, Transparency International, Cochrane, TranspariMED, and the AllTrials campaign.
The methodology used by UAEM and TranspariMED differs from that used by existing trial trackers. TrialsTracker similarly covers all interventional trials listed on Clinicaltrials.gov, but uses older data and also takes into account academic journal publication. The scope of the more recent - and highly acclaimed - FDAAA Trials Tracker is limited to recently conducted trials that are subject to U.S. reporting laws. Dr Ben Goldacre’s forthcoming EU Trials Tracker is likely to use a methodology similar to that used here by UAEM, but will cover the European trial registry rather than the American one.