Journal
JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 83, Issue -, Pages 101-107Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2016.12.018
Keywords
Data and Safety Monitoring Board; Data Monitoring Committee; Clinical trial reporting; Trial integrity
Funding
- Analgesia, Anesthetic, Addiction, Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) [U01 FD005936-01]
Ask authors/readers for more resources
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. The remaining 119 articles did not report whether or not a DMC/DSMB was used, although 59 had previously stated in a clinical trials registry entry or a published protocol that a DMC/DSMB was to be used. Conclusions: Considering the major role that DMC/DSMBs play in protecting participant safety, data quality, and interim analyses in RCTs, we recommend that authors of publications of RCTs report whether a DMC/DSMB was used and the responsibilities and members of DMC/DSMBs to increase transparency regarding study conduct. (C) 2017 Elsevier Inc. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available