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Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3218 (Published 12 September 2018) Cite this as: BMJ 2018;362:k3218

Improving updates of registry entries for published trials

The House of Commons Science and Technology Committee published the second report from its Research Integrity Inquiry this week[1], focusing on clinical trials transparency and the failure of too many researchers to publicly register or report findings from clinical trials of new drugs and medical interventions.

The Inquiry report cited Goldacre et al’s BMJ paper[2] about the EU Clinical Trials Register (EUCTR) highlighting that only half of registered trials had publicly reported results.

The automated ‘EU Trials tracker’ tool identified three MRC-sponsored trials that have been completed but have never posted results. On behalf of the MRC, we investigated these trials and found that all had published their main findings in peer reviewed journals before or within 18 months of completion. Although the EUCTR entry had not been updated, all studies had an entry in the ISRCTN registry with a link to the final report of findings. The completeness of the ISRCTN registry demonstrates the success of its policy to actively contact researchers for trial updates.

The MRC has now contacted all researchers highlighted as having a ‘due’ or ‘inconsistent’ EUCTR entry and reminded them of (i) the European Commission requirement for trial results to be posted onto the EUCTR within 12 months of completion[3], and (ii) the MRC policy requirement for registry entries to be reviewed annually until final results are reported.[4]

Our finding that all three trials have published results is not a reason for complacency as our audit has confirmed the poor maintenance of trial registry entries. Automated tools, such as the EU Trials tracker, can only produce reliable results to support compliance monitoring if the registries from which they collect data are accurate. For funders, sponsors and regulators who need to audit clinical trials transparency and raise standards, it is crucial that researchers register every trial and update and maintain these registry entries.

[1] House of Commons Science and Technology Committee. 10th Report - Research integrity: clinical trials transparency. HC 1480 (Published 30 October 2018). Accessed 01 Nov 2018 at https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/1480/14...
[2] Goldacre B, DeVito N, Heneghan C, et al. Compliance with requirement to report results on the EU Clinical Trials Register: a cohort study and web resource. BMJ 2018;362:k3218
[3] Commission Guideline - Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. (2012) Official Journal of the European Communities C302/03.
[4] Medical Research Council. Open research data: clinical trials and public health interventions. Accessed on 01 Nov 2018 at: https://mrc.ukri.org/research/policies-and-guidance-for-researchers/open...

Competing interests: RLK and KPH are employees of the Medical Research Council which is part of UK Research and Innovation.

02 November 2018
Rachel L Knowles
Programme Manager for Clinical Sciences
Kam Pou Ha
Medical Research Council (UK Research and Innovation)
rachel.knowles@mrc.ukri.org