A Data and Safety Monitoring Board (DSMB) is an independent group of clinical research experts, statisticians, ethicists and often community representatives that provides additional oversight to a clinical study. A DSMB regularly reviews blinded data that are not available to the investigators or anyone else, while a clinical trial is in progress. Based on its review of interim data, a DSMB may, at any time, recommend that a trial, or part of a trial, be stopped if there are concerns about safety, compelling evidence for a product’s effectiveness or if it is clear that a product is not effective in the study’s participants, a concept called futility. Before a trial begins, study teams define the specific “stopping rules” that would cause the study to close for efficacy, harm or futility.
Regular reviews of VOICE are conducted by the National Institute of Allergy and Infectious Diseases (NIAID) Prevention Trials DSMB, which makes its recommendations to the director of NIAID, Anthony Fauci, M.D., who decides whether to accept the DSMB’s recommendations. The DSMB for VOICE is composed of representatives from the U.S. and non-U.S. countries, including in Africa, who are independent of the study investigators, pharmaceutical sponsors and funding agency, and have no conflicts of interest in the outcomes of the studies reviewed. The DSMB for VOICE has conducted five routine reviews of the study to date. The most recent DSMB review took place on 16 September 2011. It was the third review of safety data and the second look at efficacy.
Questions and Answers on the Status of VOICE
Nov 18, 2012
Questions and Answers on Decision to Modify VOICE
Sep 28, 2011
Aug 9, 2011