Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK
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....
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| Format: | Article |
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BMJ Publishing Group
2020-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/2/e035283.full |
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| author | Rachel L Knowles Frances Rawle Kam Pou Ha Julia Mueller Rosa Parker |
| author_facet | Rachel L Knowles Frances Rawle Kam Pou Ha Julia Mueller Rosa Parker |
| author_sort | Rachel L Knowles |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a6099cedccf345e8913d9db8fd48283c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a6099cedccf345e8913d9db8fd48283c2025-02-12T03:20:10ZengBMJ Publishing GroupBMJ Open2044-60552020-02-0110210.1136/bmjopen-2019-035283Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UKRachel L Knowles0Frances Rawle1Kam Pou Ha2Julia Mueller3Rosa Parker42 Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, UK1 Medical Research Council, London, UK1 Medical Research Council, London, UKUniversity of Cambridge, Cambridge, UK1 Medical Research Council, London, UKObjectives 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.https://bmjopen.bmj.com/content/10/2/e035283.full |
| spellingShingle | Rachel L Knowles Frances Rawle Kam Pou Ha Julia Mueller Rosa Parker Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK BMJ Open |
| title | Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK |
| title_full | Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK |
| title_fullStr | Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK |
| title_full_unstemmed | Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK |
| title_short | Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK |
| title_sort | challenges for funders in monitoring compliance with policies on clinical trials registration and reporting analysis of funding and registry data in the uk |
| url | https://bmjopen.bmj.com/content/10/2/e035283.full |
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