Independent Data and Safety Monitoring in Psychiatric Intervention Research
J Clin Psychiatry 2012;73(2):e257-e263
© Copyright 2014 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
A data and safety monitoring board (DSMB) is a multidisciplinary group of scientists that monitors a randomized clinical trial. Although DSMBs have been used for clinical trials in cardiology, oncology, and infectious disease for decades, it was not until the late 1990s that the National Institute of Mental Health (NIMH) initially required a DSMB for some of its larger trials. The NIMH mandate expanded during the succeeding decade to require DSMBs for many of the clinical trials in psychiatry. In turn, the need for board members has grown quickly. The objective of this commentary is to consider the purpose of a DSMB and to describe its roles, responsibilities, composition, and implementation.
The rationale for a DSMB is to ensure the integrity and validity of the trial and, most importantly, to protect the safety of trial participants. A board conducts comprehensive reviews of accumulating unblinded data for safety and, in some trials, for efficacy. Reviewers examine adverse events and serious adverse events at regular intervals during the course of the trial. In addition, a DSMB monitors recruitment, randomization, retention, adherence, and follow-up in an effort to evaluate the validity of a trial. Because it is unethical to expose a participant to the risks of an experiment that will be unable to answer the scientific question that was postulated, a board should also evaluate the study protocol prior to trial commencement. Ultimately, a DSMB’s responsibilities are broader than that of the trial being monitored. It will protect potential study participants and eventually could affect patients seeking clinical treatment for the disorder being studied.
J Clin Psychiatry 2012;73(2):e257–e263
© Copyright 2012 Physicians Postgraduate Press, Inc.
Submitted: February 1, 2011; accepted May 25, 2011 (doi:10.4088/JCP.11com06903).
Corresponding author: Andrew C. Leon, PhD, Weill Cornell Medical College, Department of Psychiatry, Box 140, 525 East 68th St, New York, NY 10065 (firstname.lastname@example.org).