Our updated policy applies to all grants awarded by Wellcome from 1 May 2018.
We looked at the annual progress or end-of-grant reports completed by grantholders between October 2018 and March 2019 that indicated that their grant involves a clinical trial. Of the 26 grantholders who completed a report, we found that:
We’re pleased that 100% of all active trials are registered in a clinical trial registry, and that many trialists have also published their protocols, statistical analysis plans and data sharing plans. This happened even though all the grants reported here were working under our previous clinical trial policy which didn’t require these outputs to be shared.
We also analysed data from all Wellcome grants involving a clinical trial that were active on or after 1 May 2018. We did this because we:
The analysis shows that there are 131 active Wellcome grants, involving 189 clinical trials (either completed, active, or planned). Of these trials, 89 had been registered in a trial registry.
We recognise that this registration figure is low, and at odds with the more recent data presented above, but believe this is because:
Our analysis shows that the most well-used registry for Wellcome-funded researchers is clinicaltrials.gov, with 67 of 89 trials (75%) registered with them. The remaining 25% are registered in four other registries (ANZCTR, EU-CTR, ISRCTN, and TCTR).
We also reviewed the 31 trials (of the 89 registered) that had completed by May 2018. Of these, three (10%) had published summary results on a registry.
In the future, as part of an ongoing review of our policy, we’ll decide if we should require all trials we fund to be registered in a specific registry. For example, the Medical Research Council require all clinical trials it funds to be registered in ISRCTN.
We’ve published the data from this review on Figshare.
This isn’t a comprehensive picture of all clinical trials we support because our current reporting systems are complex. We’re improving these and as we get more data we’ll be able to give a more complete view in future monitoring reports.
We’re committed to making sure the researchers we fund comply with our policy.
This approach helps reduce:
These actions should lead to improved health benefits for everyone.
All Wellcome-funded researchers who are required to adhere to our policy are currently compliant.
The evidence collected shows that while researchers register their trials in an appropriate registry, they don’t always:
However, as noted above, this requirement only applies to new clinical trials we’ve funded since May 2018.
We will publish our clinical trial compliance data each year. Grantholders who fail to meet the above requirements will be ineligible to apply for further Wellcome funding until they’ve updated the trial registry.
We hope our updated policy will drive change and increase the number of researchers who adopt good practice in reporting their findings.
To make it easier for researchers to make the data underlying their research publications accessible to other researchers at the time of publication, Wellcome joined ClinicalStudyDataRequest.com, a clinical trial data sharing platform, in May 2018.
We’re pleased to announce that we now have some Wellcome-funded trials available to request through this platform. We are encouraging others to list their completed studies here too.
Read more about CSDR and what it means for grantholders.
We want to support the researchers we fund to meet our policy requirements. Get in touch to let us know how we can help you.
If you have any questions, contact Georgina Humphreys