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

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][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][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 Key Points 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. 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. 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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Protocols ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors * BCUK : Blood Cancer UK BHF : British Heart Foundation BMBF : Federal Ministry of Education and Research CRUK : Cancer Research UK DFG : Deutsche Forschungsgemeinschaft FWF : Der Wissenschaftsfonds FWO : Research Foundation Flanders IRFD : Independent Research Fund Denmark INSERM : Institut Nationale de la sante et de la recherche medicate IP : Institut Pasteur ISCIII : Instituto de Salud Carlos III ITALY MOH : Ministry of Health of Italy MRC : Medical Research Council NIHR : National Institute for Health Research RCN : Research Council Norway SNSF : Swiss National Science Foundation SRC : Swedish Research Council ZonMw : THE NETHERLANDS ORGANISATION FOR HEALTH RESEARCH AND DEVELOPMENT CIHR : The Canadian Institutes of Health Research EDCTP : European & Developing Countries Clinical Trials Partnership (EDCTP) [via the European Commission] HRC : Health Research Council of New Zealand ICMR : Indian Council of Medical Research NHMRC : National Health and Medical Research Council (Australia) [1]: #ref-1 [2]: #ref-2