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. 2020 Feb 17;10(2):e035283.
doi: 10.1136/bmjopen-2019-035283.

Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK

Rachel L Knowles  1 , Kam Pou Ha  2 , Julia Mueller  3 , Frances Rawle  2 , Rosa Parker  2
Affiliations

Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK

Rachel L Knowles et al. BMJ Open. .

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.

Keywords: audit; clinical trials; statistics & research methods.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow diagramm of trials identified for the review. ISRCTN, International Standard Randomised Controlled Trial Number; MRC, Medical Research Council.
Figure 2
Figure 2
Percentage of trials registered in ISRCTN or other registry (total n=175 trials). All trials are counted once only. Trials registered in ISRCTN are counted as ISRCTN only; trials registered in any other registry (and not in ISRCTN) are counted once in ‘Other’ registries. ISRCTN, International Standard Randomised Controlled Trial Number; MRC, Medical Research Council.
Figure 3
Figure 3
Period in months between award/trial end and reporting results (n=53 completed* trials). * Nine completed trials that have not yet reported findings were excluded
Figure 4
Figure 4
Reporting (or publication) of main results by year when award ended.
See this image and copyright information in PMC

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