The Medical Research Council’s (MRC) policy on open research data: clinical trials and public health interventions requires MRC-funded researchers to:
- register trials in the ISRCTN registry within 12 months of award start
- publicly report results within 24 months of trial end.
Research data should be made available for sharing and re-use with as few restrictions as possible.
What did we do?
Since 2017, MRC has carried out annual reviews of all trials funded by MRC to assess compliance with our policy. The results from our 2020 review are presented below.
What did we find out?
Between 1 February 2011 and 1 February 2019, MRC:
- awarded around £30 million each year to fund clinical trials
- funded 273 clinical trials.
Of 273 trials that started during 2011 to 2019:
- 100% were publicly registered in a clinical trials registry
- 48% were registered in the ISRCTN registry
- 69% of trials that started in the last year of the review were registered before recruitment began.
Trials reporting results
Of 130 trials that were completed by 1 February 2019:
- 37% had publicly reported trial findings within 12 months of completion
- 68% had publicly reported trial findings within 24 months of completion
- 7% had finished for at least 12 months but had not reported results.
Trial data shared
MRC encourages researchers to share trial data so it can contribute to new research and add value. However, we are aware that sharing may not always be possible as it is essential to protect the confidentiality of participants.
The MRC policy on ‘open research data: clinical trials and public health interventions’ was published in 2016.
Since then, there has been a steady year-on-year rise in researchers reporting that they have shared trial data. This is from zero datasets shared in 2017 to 24 (18%) completed trials sharing data in the most recent review.
Registration of MRC trials is consistently 100%, however only half are registered in the ISRCTN registry, which is MRC’s preferred registry.
The percentage of new trials registered before the trial begins is high but the goal should be 100%.
The percentage of completed trials that publicly report the main findings within 12 months of the trial end has increased each year. However, one-third of completed trials take longer than 24 months to report results.
Sharing of data with researchers outside the trial team is increasing year-on-year.
Changes to MRC requirements
MRC will continue to review trial registration and reporting each year.
To improve compliance with MRC policy, from 2020:
- MRC funding will be temporarily suspended for any new trial that is not registered with the ISRCTN within 12 months. Registration in regional World Health Organization primary registries will be accepted for global trials
- new funding awards to applicants who have not reported findings from a previous MRC-funded trial will not commence until the earlier trial has been publicly reported.
- a summary report Clinical Trials Review 2020
- 2020 review data.
- a summary report Clinical Trials Review 2019
- 2019 review data.
- a review was published in BMJ Open
- 2018 review data.
- a summary report Clinical Trials Review 2017
- 2017 review data.
Contact for more information
If you have any queries about the review, email: firstname.lastname@example.org