Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions.

ABSTRACT:

Objective

To determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.

Design

Audit of records.

Setting

Phase III clinical trials registered on the UK's research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.

Main outcome measures

Proportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.

Results

Out of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1

SUBMITTER: Raza MZ 

PROVIDER: S-EPMC7045144 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature