When we signed the World Health Organization (WHO) statement on clinical trial transparency, we promised to monitor compliance with our clinical trials policy and publish the results annually. Here are our latest findings.
Our updated policy applies to all grants awarded from 1 May 2018 that involve a clinical trial.
As part of our commitment, we promised to monitor compliance with our updated policy and publish the summary results.
Using grant application data we looked at all the grants involving clinical trials that were awarded from 1 May 2018, and therefore required to adhere to our policy.
Of the 92 grants we found that:
We also looked at reporting data and registry entries for Wellcome-supported trials that were active from May 2018 onwards, to see how frequently trialists publish their protocols, statistical analysis plans and data sharing plans. We found:
Note that not all of these are subject to the May 2018 policy and denominators are not consistent due to incomplete reporting.
The most well-used registry for Wellcome-funded researchers is clinicaltrials.gov, with 137 out of 196 (70%) registered with them and 33 (17%) registered with ISRCTN. The remaining 13% are registered in 7 other registries.
Our review identified 88 out of 196 registered trials that were completed more than 12 months ago according to dates on registry entries. Of these, 15 (17%) had published summary results in a registry. Although posting summary results was not a Wellcome policy requirement for the majority of these studies (only 3 were awarded after 1 May 2018) it is disappointing to see such a low number of trialists update their registry entries. Many of these trials will have published findings in peer-reviewed articles, but we have not tracked this data, nor the possible publication bias for positive results.
We’ve published the full dataset use for this review on FigShare.
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.
A small number of Wellcome-funded researchers have not shared summary results within 12 months of the primary study completion date. This is in breach of our grant conditions. As outlined above, we will follow up with these researchers and apply sanctions, where appropriate.
The evidence shows that, while researchers register their trials in an appropriate registry, they don’t always:
We will publish our clinical trial compliance data each year. Grantholders who fail to meet the above requirements will be notified and given reasonable time to update their registry entries. But if they remain non-compliant, they will not be eligible to apply for further Wellcome funding.
We hope our updated policy will drive change and increase the number of researchers to adopt good practice in reporting their findings.
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.