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Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review
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Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review
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Journal Article
Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review
2017
Overview
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.
Systematic review of RCTs published in 2014 in Annals of Internal Medicine, BMJ, NEJM, JAMA, JAMA Internal Medicine, and Lancet.
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.
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.
Publisher
Elsevier Inc,Elsevier Limited
Subject
/ Clinical Trials Data Monitoring Committees - organization & administration
/ Clinical Trials Data Monitoring Committees - standards
/ Data and Safety Monitoring Board
/ Humans
/ Medicine
/ Periodicals as Topic - standards
/ Randomized Controlled Trials as Topic - methods
/ Randomized Controlled Trials as Topic - standards
/ Safety
