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Major research funders tighten clinical trial reporting rules, announce sanctions

Several medical research funders in the United States are now working to strengthen their clinical trial transparency policies, and a major British funder announced that it will soon start cutting off money to grantees that fail to make their clinical trial results public.

Funders’ efforts to improve trial reporting come in the wake of a TranspariMED report published earlier this week. The report found that many funders had failed to adopt 11 safeguards against research waste recommended by the World Health Organisation.

Without these safeguards, there is a high risk that clinical trial results are published late or not at all, wasting money and harming patients and public health.

Below initial reactions by funders, as reported by STAT News and BMJ News.

Positive funder reactions

Alzheimer’s Association (USA, nonprofit)

Rating: 2/11 safeguards (does not capture recent improvements)

Statement: “We certainly learned from the initial findings of this draft paper, to the eventual benefit of all stakeholders. As noted, we immediately modified some of our language and policies, and extensively track the registrations of the clinical trials we fund. At the same time, we view our policies as being more compliant than the authors’ strict, to-the-letter interpretation of the WHO statement standards.”

TranspariMED comment: Our assessment was unable to capture the recent improvements made by the Alzheimer’s Association. Note that if a funder policy stated that grantees ‘should’ register clinical trials, TranspariMED rated this as non-binding and awarded no points. We understand that this can be frustrating for funders. We encourage all funders to use unambiguous language, such as ‘must’ (binding) or ‘is recommended’ (non-binding), so that grantees clearly understand the rules.

Susan G. Komen for the Cure (USA, nonprofit)

Current rating: 5/11 safeguards

Statement: “It was wonderful to see where we benchmark compared to other philanthropic, non-profit research funders.”

American Heart Association (USA, nonprofit)

Current rating: 3/11 safeguards

According to STAT News, the association “is forming an advisory group to solicit recommendations for making changes and, meanwhile, will require trials to include ID numbers in publications.”

Juvenile Diabetes Research Foundation (USA, diabetes nonprofit)

Current rating: 4/11 safeguards

Statement: “JDRF is open to improvement.”

Gates Foundation disappoints

Gates Foundation (USA, nonprofit)

Current rating: 1/11 safeguards

Gates Foundation statement: “The foundation continues to support the principles laid out in the 2017 WHO joint statement. While we haven’t created mandatory public policies to address every principle, we’ve worked with our partners with a particular focus on ensuring rapid and responsible access to all data generated and more recently to provide our grantees with the additional resources they need to design and support high-quality trials that are likely to be informative.”

TranspariMED comment: In 2017 Gates Foundation formally committed to adopting all 11 WHO-recommended research waste safeguards within a year. More than five years later, Gates Foundation has only adopted 1 of the 11 safeguards. ‘High-quality trials’ are not going to be ‘informative’ if their results are not made public. Gates Foundation promised in 2017 to publish annual monitoring reports showing which trial results have been made public, and which have not. Spare us the spin and show us those data, please.

UK funder gears up for sanctions

Medical Research Council (UK, public funder)

Current rating: 9/11 safeguards

According to BMJ News:

“In 2020 the MRC hardened its position, saying it would suspend funding for new trials not registered on time… and would refuse fresh money to trial investigators who had neglected to report findings from earlier trials… The MRC is now auditing the first two years of new grants since it announced penalties (February 2020 to January 2022) and expects to finalise the figures this month…”

No sanctions have been imposed so far, but… this could change at the end of May if reminders are ignored.”

TranspariMED will re-assess all funders in early 2024 to document their progress.

Our report contains useful tools for funders that wish to strengthen their policies:

TranspariMED_research funder policies_report_20230418
Download PDF • 554KB

Please make a small donation today so that we can continue our efforts to reduce research waste in medicine.

On behalf of lead researchers Marguerite O’Riordan and Elise Gamertsfelder, TranspariMED would like to thank all funders who communicated with us during this assessment, and those that are now working to improve their operations.


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