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Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK
  1. Rachel L Knowles1,
  2. Kam Pou Ha1,
  3. Julia Mueller2,
  4. Frances Rawle1,
  5. Rosa Parker1
  1. 1 Medical Research Council, London, UK
  2. 2 Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK
  1. Correspondence to Dr Rachel L Knowles; rachel.knowles{at}mrc.ukri.org

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.

  • clinical trials
  • statistics & research methods
  • audit
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Footnotes

  • Twitter @Julia_Namanka

  • Contributors RLK, RP and FR: conceived and designed the study. JM, KPH and RK: extracted and analysed data and all authors interpreted the data. RLK and RP: drafted the manuscript. All authors reviewed and approved the final manuscript.

  • Funding JM and KPH were funded by MRC Policy Internships. This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. The dataset is available on the MRC website as a downloadable file or on enquiry to the MRC.