Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review.

ABSTRACT:

Objective

To examine whether primary reports of randomized clinical trials (RCTs) in six high-impact, general medical journals reported (1) whether or not a Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB) was used and (2) the composition of the responsibilities of the reported DSMB/DMCs.

Study design and setting

Systematic review of RCTs published in 2014 in Annals of Internal Medicine, BMJ, NEJM, JAMA, JAMA Internal Medicine, and Lancet.

Results

Of the 294 articles identified, 174 (59%) mentioned using a DMC/DSMB. Of these 174, 126 (72%) indicated at least one responsibility of the DMC/DSMB, 26% listed the names of the DMC/DSMB members, and another 14% listed both their names and affiliations. Only one article stated that a DSMB was not used. Th

SUBMITTER: Gewandter JS 

PROVIDER: S-EPMC5780643 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature