Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review.
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.
['Gewandter|Jennifer S|JS|', 'Kitt|Rachel A|RA|', 'Hunsinger|Matthew R|MR|', 'Poku|Joseph|J|', 'Lozano|Jacqueline|J|', 'Chaudari|Jenna|J|', 'Evans|Scott|S|', 'Gross|Robert A|RA|', 'McDermott|Michael P|MP|', 'Rowbotham|Michael C|MC|', 'Turk|Dennis C|DC|', 'Dworkin|Robert H|RH|']
D026661:Clinical Trials Data Monitoring Committees D006801:Humans D010506:Periodicals as Topic D016032:Randomized Controlled Trials as Topic
Data Monitoring Committee Data and Safety Monitoring Board Clinical trial reporting Trial integrity