Registration audit of clinical trials given a favourable opinion by UK research ethics committees

Carla Denneny, Sue Bourne, Simon E. Kolstoe*

*Corresponding author for this work

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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.

Original languageEnglish
Article numbere026840
JournalBMJ Open
Volume9
Issue number2
DOIs
Publication statusPublished - 21 Feb 2019

Keywords

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

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