Jennifer S Gewandter1, Rachel A Kitt2, Matthew R Hunsinger3, Joseph Poku2, Jacqueline Lozano2, Jenna Chaudari2, Scott Evans4, Robert A Gross5, Michael P McDermott6, Michael C Rowbotham7, Dennis C Turk8, Robert H Dworkin2. 1. Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA. Electronic address: jennifer_gewandter@urmc.rochester.edu. 2. Department of Anesthesiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA. 3. School of Graduate Psychology, Pacific University, College Way, Hillsboro, OR, USA. 4. Department of Biostatistics, Harvard University, Elmwood Avenue, Boston, MA, USA. 5. Department of Neurology, University of Rochester, Elmwood Avenue, Rochester, NY, USA; Department of Pharmacology & Physiology, University of Rochester, Elmwood Avenue, Rochester, NY, USA. 6. Department of Biostatistics and Computational Biology, University of Rochester, Elmwood Avenue, Rochester, NY, USA. 7. California Pacific Medical Center Research Institute, Brannan St, San Francisco, CA, USA. 8. Department of Anesthesiology and Pain Medicine, University of Washington, NE Pacific Street, Seattle, WA, USA.
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. 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.
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.
Authors: Matthew R Sydes; Douglas G Altman; Abdel B Babiker; Mahesh K B Parmar; David J Spiegelhalter Journal: Clin Trials Date: 2004-02 Impact factor: 2.486