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

Abstract

Objectives: Assess the extent to which the clinical trial registration and reporting policies of 25 of the worlds largest public and philanthropic medical research funders meet best practice benchmarks as stipulated by the 2017 WHO Joint Statement,(1) and document changes in the policies and monitoring systems of 19 European funders over the past year. Design, Setting, Participants: Cross sectional study, based on assessments of each funders publicly available documentation plus validation of results by funders. Our cohort includes the 25 of the largest public and philanthropic medical research funders in Europe, Oceania, South Asia and Canada. Of these, 19 were previously assessed against the same benchmarks, enabling us to document changes over time. Interventions: Scoring of all 25 funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into 3 primary categories: trial registries, academic publication and monitoring, plus validation of results by funders. Main outcome measures: The primary outcome measure is how many of the 11 WHO best practice items each of the 25 funders has put into place, and changes in the performance of 19 previously assessed funders over the preceding year. Results: The 25 funders we assessed had put into place an average of 5/11 (49%) WHO best practices. The best practice adopted by most funders 16/25 (64%) was mandating open access publication in journals. In contrast, only 6/25 funders (24%) took PI past reporting record into account during grant application reviews. Funders performance varied widely from 0/11 to 11/11 WHO best practices adopted. Of the 19 funders for which 2021 baseline data were available,(2) 10/19 (53%) had strengthened their policies over the preceding year. Conclusions: Most medical research funders need to do more to curb research waste and publication bias by strengthening their clinical trial policies.