Medical research funders across Europe tighten rules on clinical trial reporting

Eight of the 21 largest public and philanthropic medical research funders in Europe are stepping up their efforts to improve clinical reporting, following an assessment that found widespread gaps in existing research waste safeguards.

At present, many academic clinical trials in Europe fail to make their results public, wasting taxpayers’ money and leaving large gaps in the medical evidence base.

The public institutions that hand out money to medical researchers can prevent such waste by putting into place eleven safeguards recommended by the World Health Organisation.

Which funders are preventing research waste?

Funders across Europe varied widely in their adoption of WHO-recommended research waste safeguards, the assessment conducted in spring 2021 showed.

The UK’s National Institute for Health Research (NIHR) emerged as the top performer, with 10 out of the 11 safeguards in place. The Medical Research Council (also UK) and the Norwegian Research Council also performed very strongly.

At the bottom of the ranking, the Ministry of Health of Italy had not put a single safeguard into place. It neither required researchers to register clinical trials, nor to make their results public, nor did it check whether researchers did so in practice.

(French CNRS and the German Bundesministerium fuer Gesundheit were included in the assessment for methodological reasons, but in practice are not significant clinical trial funders.)

Which funders are stepping up efforts?

The research team contacted each funder with their assessment results and an invitation to outline any plans to strengthen their policies and monitoring processes in future.

Eight funders either immediately strengthened their policies or announced plans to do so in future. Most notably:

• Wellcome Trust almost immediately strengthened its policies in response to the outreach [not reflected in the ranking above]

• Inserm (France) adopted a set of very strong policies in July 2021 [not reflected in the ranking above]

• The Norwegian Research Council announced that it was already monitoring trial publication and would publish its first monitoring report during 2022 – the first funder outside the UK to do this

Disappointingly, the Ministry of Health of Italy never responded, further cementing that country’s reputation as a black hole for clinical trials. (Some individual Italian research organisations have embraced transparency, but the Italian medicines regulator AIFA appears to have its head firmly stuck in the sand.)

Which transparency safeguards are most common?

A comparison of the transparency policies adopted by European funders yielded surprising results:

• Remarkably, only 14 out of 21 funders required clinical trials to be registered, even though this has been a global ethics requirement for nearly a decade.

• Even in the wake of the pandemic, which illustrated how rapidly trial results can be made public, only 6 of 21 funders required results to be made public on trial registries within a year, as recommended by the WHO.

• On the positive side, 16 of 21 funders now require publications to be open access to ensure that the results of publicly funded research are widely accessible.

The authors of the paper note that:

“Every policy element that we assessed has already been implemented by at least three funders, demonstrating feasibility.”

“Funders worldwide may use our scoring tool to identify gaps in their policies and processes. We have created a template policy document with example texts for each policy item to facilitate the adoption of WHO best practices by funders.”

Hannah Hope, open research lead at Wellcome Trust, told STAT News that:

“Transparency in clinical trials is important to us and we thank the researchers for their paper which is a helpful prompt for the entire science community. Achieving WHO best practice requires collective action from across the research ecosystem."

"More funders and institutional trial sponsors need to take a proactive approach to support researchers in

ensuring clinical trial standards are met.”

Till Bruckner, founder of TranspariMED and lead author of the study while working as a researcher at the QUEST Center for Reproducible Research, said:

“The cost of adopting strong policies and monitoring compliance is minimal compared with the immense human and financial cost of research waste.”

“We were delighted to receive such positive reactions from many funders across Europe. Hopefully, funders worldwide will now use our assessment tool and template to strengthen their safeguards to ensure that the medical research they support really ends up benefiting the public.”

“We plan to repeat this study in the near future to document funders’ progress over time.”

The study was published by JAMA Network Open today. An online supplement provides detailed scoring information for each funder, a list of policy changes announced by funders, and a template best practices policy. The scoring tool and all correspondence with funders have been archived online.

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TranspariMED note to fellow researchers:

This study was easy to run, and remarkably successful in driving meaningful positive change in the policies of funders that collectively disburse billions of Euros every year. It is currently being replicated with the 15 largest funders in the United States by a separate team, and TranspariMED will probably assess additional funder cohorts in future.

TranspariMED strongly encourages other meta-researchers (and advocacy groups!) to replicate this study with new funder cohorts, or replicate past assessments, but in that case please notify TranspariMED beforehand so that we as a community can avoid duplicating each others’ work. If anyone else wants to assess a specific cohort, we will step back and not do it.

Alternatively, we are always happy to hear from researchers who want to participate in future assessments of this kind. Thank you.