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 world’s 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 funder’s 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’s 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. Key Points WHAT IS ALREADY KNOWN ABOUT THIS TOPIC Strong clinical trial registration and reporting policies coupled with monitoring and sanctions can reduce research waste, curb publication bias and promote transparency. A 2021 assessment found that 19 European medical research funders’ policies fell short of WHO best practices. WHAT THIS STUDY ADDS This is the first study to assess the clinical trial registration and reporting policies of a global cohort of 25 major medical research funders against WHO best practices, identifying gaps in the research waste safeguards of key players across Europe, Oceania, South Asia and Canada. In addition, the study assesses the progress made by 19 funders in the recent past. HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY This study enables funders worldwide to identify and address gaps in their clinical trial transparency policies by pinpointing exactly where they currently fall short of WHO best practices. It also enables policy makers and citizens to assess whether public bodies tasked with furthering medical knowledge have adopted adequate safeguards against research waste and publication bias.

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