title: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA. Electronic address: jennifer_gewandter@urmc.rochester.edu.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
authors.affiliation: Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA.
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Kitt
authors.affiliation: School of Graduate Psychology, Pacific University, College Way, Hillsboro, OR, USA.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Hunsinger
authors.affiliation: Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Poku
authors.affiliation: Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Lozano
authors.affiliation: Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA.
authors.forename: Jenna
authors.initials: J
authors.lastname: Chaudari
authors.affiliation: Department of Biostatistics, Harvard University, Elmwood Avenue, Boston, MA, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Evans
authors.affiliation: Department of Neurology, University of Rochester, Elmwood Avenue, Rochester, NY, USA; Department of Pharmacology & Physiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Gross
authors.affiliation: Department of Biostatistics and Computational Biology, University of Rochester, Elmwood Avenue, Rochester, NY, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.affiliation: California Pacific Medical Center Research Institute, Brannan St, San Francisco, CA, USA.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Rowbotham
authors.affiliation: Department of Anesthesiology and Pain Medicine, University of Washington, NE Pacific Street, Seattle, WA, USA.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.affiliation: Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration / Q000592:standards; D006801:Humans; D010506:Periodicals as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards
keywords: Clinical trial reporting; Data Monitoring Committee; Data and Safety Monitoring Board; Trial integrity