Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK. Issue 2 (17th February 2020)

• Record Type: Journal Article
• Authors: Knowles, Rachel L; Ha, Kam Pou; Mueller, Julia; Rawle, Frances; Parker, Rosa
• Is Part Of: BMJ open. Volume 10:Issue 2(2020)
• Publication Date: 2020-02-17
• Subjects: clinical trials -- statistics & research methods -- audit; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-035283
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objectives: To evaluate compliance by researchers with funder requirements on clinical trial transparency, including identifying key areas for improvement; to assess the completeness, accuracy and suitability for annual compliance monitoring of the data routinely collected by a research funding body. Design: Descriptive analysis of clinical trials funded between February 2011 and January 2017 against funder policy requirements. Setting: Public medical research funding body in the UK. Data sources: Relevant clinical trials were identified from grant application details, post-award grant monitoring systems and the International Standard Randomised Controlled Trial Number (ISRCTN) registry. Main outcome measure: The proportion of all Medical Research Council (MRC)-funded clinical trials that were (a) registered in a clinical trial registry and (b) publicly reported summary results within 2 years of completion. Results: There were 175 grants awarded that included a clinical trial and all trials were registered in a public trials registry. Of 62 trials completed for over 24 months, 42 (68%) had publicly reported the main findings by 24 months after trial completion; 18 of these achieved this within 12 months of completion. 11 (18%) trials took >24 months to report and 9 (15%) completed trials had not yet reported findings. Five datasets were shared with other researchers. Conclusions: Compliance with the funder policy requirements on trial registration was excellent. Reporting of the main findings was achieved for most trials within 24 months of completion; however, the number of unreported trials remains a concern and should be a focus for future funder policy initiatives. Identifying trials from grant management and grant monitoring systems was challenging therefore funders should ensure investigators reliably provide trial registries with information and regularly update entries with details of trial publications and protocols.