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

OBJECTIVES:
To evaluate compliance by researchers with funder requirements on clinical trials 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 2016 against funder policy requirements.
SETTING:
Public medical research funding body in the United Kingdom.
DATA SOURCES:
Information on relevant clinical trials was extracted from grants monitoring systems and the ISRCTN registry.
MAIN OUTCOME MEASURE:
Proportion of all MRC-funded clinical trials that were (a) registered in a clinical trials registry and (b) publicly reported summary results within 2 years of completion.
RESULTS:
There were 175 clinical trial grants awarded 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. Eleven (18%) trials took longer than 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 trials 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. Repurposing routine data from a grants monitoring system was challenging therefore funders should ensure investigators maintain high quality registry entries with information that can be used for annual monitoring.