Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resourceBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3218 (Published 12 September 2018) Cite this as: BMJ 2018;362:k3218
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The House of Commons Science and Technology Committee published the second report from its Research Integrity Inquiry this week, 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 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, and (ii) the MRC policy requirement for registry entries to be reviewed annually until final results are reported.
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.
 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...
 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
 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.
 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.
I read with great interest a recently published article by Goldacre et al., reporting the poor completion and compliance rates of clinical trials on the EU Clinical Trials Register (EUCTR)(1). As a medical student, I wish to highlight what this means and how it may impact us as students.
Medical students and junior doctors alike often find ways and means to boost their curriculum vitae, as a way to increase their chances of securing a specialty training spot. Aside from taking part in community involvement projects, competitive sports and arts, research serves as an important avenue for students to pick up soft skills (writing, statistics), and attain tangible achievements, such as a conference presentation or ideally a publication.
It is therefore worrying that only half of all trials reported their results, a finding previously shown in other studies(2, 3). Hence, this highlights that problems of trial delay, discontinuation, and publication continue to remain unresolved.
These trends may deter medical students from doing research for whatever reason or motivation they initially had, a dreaded consequence that impairs continuous efforts to encourage and groom young or aspiring clinician-scientists. It is hence advisable for both supervisors and students to work towards a feasible project with a realistic timescale, to prevent unnecessary wastage of time and effort, and discouragement in their academic pursuits. Students also need to appreciate that medical research comprises of an entire spectrum of study designs, from clinical trials, to observational studies, case reports, and review articles. Each offers its own unique learning experience, without compromising on the chances of securing a conference presentation or publication. It is important to understand that clinical trials are not the Be-all and End-all of research, as opportunities are aplenty for us to explore and undertake research of different designs.
1. Goldacre B, DeVito NJ, Heneghan C, Irving F, Bacon S, Fleminger J, et al. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource. BMJ (Clinical research ed). 2018;362:k3218.
2. Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ (Clinical research ed). 2013;347:f6104.
3. Chapman SJ, Shelton B, Mahmood H, Fitzgerald JE, Harrison EM, Bhangu A. Discontinuation and non-publication of surgical randomised controlled trials: observational study. BMJ (Clinical research ed). 2014;349:g6870.
Competing interests: No competing interests
Re: Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
This publication reports interesting data.
I wonder why some factors influencing the result (e.g. universities lacking the knowledge/process to comply) were mentioned, while others were not: the number of 'commitment studies', i.e. studies performed as part of a commitment to regulatory authorities
Competing interests: pharmaceutical industry employee