Our volunteers just rescued several clinical trials from becoming research waste. Here’s how.
UK universities and publish health trusts have promised to make public the results of 14 unreported clinical trials in the course of a pilot project run by TranspariMED volunteers.
The project identified 145 clinical trials completed during 2017 by ten major medical research institutions in the UK. TranspariMED volunteers then searched for the results of these trials on registries and in scientific journals. They found that 18 trials that had enrolled 637 people remained completely unreported.
After being contacted by TranspariMED, institutions promised to make public the results of 14 unreported trials, which had involved 504 people.
For the remaining 4 trials, institutions indicated that there was no data of value to publish due to early termination of the trial (3 trials) or quality issues rendering the trial data useless (1 trial).
Small project - large impact
Till Bruckner, founder of TranspariMED, said:
“Our project probably saved medical research worth millions of pounds from being lost forever. Contacting sponsors about their unreported trials appears to be a highly cost-effective way to expand the global store of medical knowledge.”
“Hopefully, this pilot project will encourage trial registries, research funders, campaign groups and meta-researchers to become more proactive in contacting institutions about trials in danger of becoming research waste.”
UK institutions walk the transparency talk
Institutions' responses to TranspariMED showed that many were not aware of older unreported trials.
Why not? Major UK institutions now systematically monitor their drug trials and ensure that results are rapidly made public, but many still do not track the fate of their older non-drug trials.
After being alerted to the problem, institutions’ reaction to TranspariMED’s outreach was extremely positive overall.
Imperial College London uploaded several trial results onto ClinicalTrials.gov shortly after being contacted.
Guy's and St Thomas’ NHS Foundation Trust already had plans to conduct a full audit of trials conducted over the past five years.
Many institutions have put into place strong safeguards against future research waste (all sponsor responses archived here)
There is no legal or regulatory requirement for UK institutions to upload missing results for older non-drug trials – so their actions are entirely voluntary. (Under UK Health Research Authority rules, all trials have to make results public within a year, but this does not apply retrospectively to trials comnpleted long ago.)
What should UK regulators do?
The report concludes that the UK Health Research Authority should:
Require all trial results to be made public on trial registries, as recommended by the World Health Organisation, as registry reporting has significant advantages over other publication formats
Require sponsors to add a hyperlink to every outcome publication to the relevant registry entry.
Establish a pathway allowing sponsors to apply for HRA permission to ‘write off’ a trial’s results in exceptional circumstances, for example if very few patients were recruited.
Full report and dataset online
The preprint publication and dataset are now available online, together with the study protocol and institutions’ responses containing details about their plans and research waste safeguards.
Help us to save even more clinical trials
TranspariMED will next scale up this approach with a far larger cohort of UK trials.
Please make a small donation to support our efforts to save more medical evidence from becoming research waste.
Alternatively, if you want to volunteer to join future projects like this, please contact us.
TranspariMED thanks the charity HealthSense UK for funding this research, and the following volunteers for making the project possible and helping to rescue unreported clinical trials: Daniel Sánchez, Aminul Schuster, Belén Chavarría, Carolina Cruz, Fabiola Karely Lizárraga Illán, Ronak Borana, and Tungamirai Ishe Bvute.