Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies

Abstract

IMPORTANCEResearch funders can reduce research waste and publication bias by requiring their grantees to register and report clinical trials. OBJECTIVE To determine the extent to which 21 major European research funders' efforts to reduce research waste and publication bias in clinical trials meet World Health Organization (WHO) best practice benchmarks and to investigate areas for improvement. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study was based on 2 to 3 independent assessments of each funder's publicly available documentation and validation of results with funders during 2021. Included funders were the 21 largest nonmultilateral public and philanthropic medical research funders in Europe, with a combined budget of more than US $22 billion.EXPOSURES Scoring of funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into 4 broad categories: trial registries, academic publication, monitoring, and sanctions. Funder references to reporting standards were captured. MAIN OUTCOMES AND MEASURESThe primary outcome was funder adoption or nonadoption of 11 policy and monitoring measures to reduce research waste and publication bias as set out by WHO best practices. The secondary outcomes were whether and how funder policies referred to reporting standards. Outcomes were preregistered after a pilot phase that used the same outcome measures. RESULTS Among 21 of the largest nonmultilateral public and philanthropic funders in Europe, some best practices were more widely adopted than others, with 14 funders (66.7%) mandating prospective trial registration and 6 funders (28.6%) requiring that trial results be made public on trial registries within 12 months of trial completion. Less than half of funders actively monitored whether trials were registered (9 funders [42.9%]) or whether results were made public (8 funders [38.1%]).Funders implemented a mean of 4 of 11 best practices in clinical trial transparency (36.4%) set out by WHO. The extent to which funders adopted WHO best practice items varied widely, ranging from 0 practices for the French Centre National de la Recherche Scientifique and the ministries of health of Germany and Italy to 10 practices (90.9%) for the UK National Institute of Health Research. Overall, 9 funders referred to reporting standards in their policies. CONCLUSIONS AND RELEVANCEThis study found that many European medical research funder policy and monitoring measures fell short of WHO best practices. These findings suggest that funders worldwide may need to identify and address gaps in policies and processes.

Adoption of the World Health Organization’s best practices in clinical trial registration and reporting among top public and philanthropic funders of medical research in the United States

“…[17] Complementary to this, the NIH issued a dissemination policy that covers all NIH-funded trials, not just ACTs. [18] However, as found in this and several other studies, [19][20][21] legal requirements, ethical considerations, and reality do not always coincide. Notably, federally funded studies were found to be significantly less likely to adhere to FDAAA mandates than industry sponsored trials.…”

“…This study builds on prior research that reveals significant gaps between WHO Joint Statement benchmarks and the policies of major medical research funders in the US and Europe. [19][20][21] This study differs from prior studies of US funders by specifically assessing policy elements contained in the WHO Joint Statement, as well as assessing a larger number of US funders than previously studied. [20]…”

“…We compiled a list of large (>US$50 million annual spend) US medical research funders using data that was published in a peer-reviewed journal in 2016 [11] and has been used for cohort selection in at least three separate studies of clinical trial policy transparency. [19][20][21] The list includes only noncommercial funders, categorized as either public or philanthropic.…”

Are European Clinical Trial Funders Policies on Clinical Trial Registration and Reporting Improving? – A Cross-Sectional Study

“…(8) Multiple previous studies have assessed funders' clinical trial policies. (2,11,14) An assessment of 21 European funders conducted in 2021 used 11 items contained in the WHO Joint Statement as its benchmark. (2) It found that funders had only adopted a mean of 4/11 (36%) of WHO best practices in clinical trial transparency.…”

“…The authors included a template policy document to facilitate the adoption of WHO best practices. (2) We build on this previous work by assessing a broader cohort of 25 funders worldwide using the same methodology, including 19 of the European funders that had been assessed one year earlier.…”