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Registration audit of clinical trials given a favourable opinion by UK research ethics committees
  1. Carla Denneny1,
  2. Sue Bourne1,
  3. Simon E Kolstoe2
  1. 1 Health Research Authority, London, UK
  2. 2 School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, UK
  1. Correspondence to Dr Simon E Kolstoe; simon.kolstoe{at}port.ac.uk

Abstract

Objective To determine levels of public registration for a cohort of clinical trials reviewed and given a favourable opinion by research ethics committees in the United Kingdom.

Study design Audit of records.

Setting Clinical trials receiving a favourable ethics opinion between 1 January 2016 and 30 June 2016.

Main outcome measures Correlation between trials on the UK research ethics committee database and any primary registry entry on the WHO International Clinical Trials Registry Platform or clinicaltrials.gov as of 29 August 2017 (14 to 20 months after the favourable ethics committee opinion).

Results Over the study period 1014 trials received a favourable ethics opinion, with 397 (39%) registered on the European Union Drug Regulating Authorities Clinical Trials database, and 18 with an agreed clinical trial registration deferral. Excluding these trials, the total number subsequently requiring registration was 599, and of these 405 (40% of total) were found to be registered. Follow-up with the 194 investigators or sponsors of trials not found to be registered produced 121 responses with a further 10 (1%) trials having already registered, 55 commitments to register and a variety of other responses. The overall registration rate was therefore 80%.

Conclusions Despite researchers and sponsors being reminded that registration of clinical trials is a condition of the research ethics committee (REC) favourable opinion, one-fifth of clinical trials either had not been registered, or their registration could not easily be found, 14 to 20 months after receiving the favourable opinion letter. The methodology trialled here proved effective, and although there are positive indications of a culture change towards greater registration, our results show that more still needs to be done to increase trial registration.

  • registration
  • transparency
  • research registry
  • research ethics
  • regulator

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors CD and SB designed and conducted the audit and provided an initial report to the HRA. SEK re-analysed the results and wrote the paper.

  • Funding The initial audits were funded by the Health Research Authority.

  • Competing interests CD and SB were employed by the HRA during the audit, although CD has since left the HRA. SEK chairs an HRA research ethics committee, is a member of the HRA’s Confidentiality Advisory Group and is an academic member of both the HRA’s National Research Ethics Committee Advisors Panel (NREAP) and its Transparency Forum. He is on the board of advisors to the Research Registry.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The initial audit reports that this study is based on are available on the HRA website.

  • Patient consent for publication Not required.

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