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

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 Clin

SUBMITTER: Denneny C 

PROVIDER: S-EPMC6398673 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature