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Research

MRC Review of Clinical Trials

The MRC Policy on Open Research Data: clinical trials and public health interventions (PDF, 112KB) requires that MRC-funded clinical trials are:

  • registered with the ISRCTN registry before they start,
  • publish main findings without unreasonable delay and usually within 12 months of trial completion.

The MRC expects researchers:

  • to make research data available for sharing and re-use with as few restrictions as possible, in a timely and responsible manner.

In 2017, the MRC carried out a review of all clinical trials funded by the MRC over the five-year period 2011 to 2016.

Results

Trials funded

In the five years between February 2011 and February 2016, the MRC:

  • awarded around £30 million each year to fund clinical trials,
  • supported 117 clinical trials.

Trials registered

Of 107 trials which started during the review period:

  • 94% were publicly registered in a clinical trials registry before starting,
  • 37% were registered in the ISRCTN registry. The ISRCTN is a WHO primary registry and has been the MRC recommended registry since 2013.

Trials published

Of 40 trials completed during the review period:

  • 82% had published findings
  • 65% were published within 12 months of completion; 42% published their main findings within 12 months of completion.

Sharing trial data

Overall, 24 clinical trials had produced a trial dataset that was available for sharing, and seven trials had shared this dataset.

Summary

Trial registration is good overall but a small number of trials were not registered before they started recruitment.

The majority of completed trials had published results, however the timeliness of publication of main findings could be improved.

So far, only a small number trials have produced datasets that have been shared with other researchers.

Next steps

MRC-funded researchers should ensure that they report registration, publications and data-sharing for all clinical trials in their annual monitoring return.

The MRC will ensure that all new and existing award holders are provided with relevant information about MRC requirements in award letters, and terms and conditions, including the:

  • requirement to register in the ISRCTN registry, and how to claim the registration fee within the MRC award,
  • requirement for timely publication of main findings, regardless of whether these are positive or negative.

The MRC will continue to track registration and publications against the MRC Policy on Open Research Data: clinical trials and public health intervention. The review will be repeated in 2018.

Further information

A summary review report (PDF, 90KB) is available to download.

Contact

If you have any queries about the review please contact rachel.knowles@headoffice.mrc.ac.uk