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Ann Melvin, MD
Associate Program Director, Research Subject Advocate Program
Office: CHRMC W-7871
Mailstop W-6605
(206) 987-2535
ann.melvin@seattlechildrens.org

Data and Safety Monitoring Boards (DSMBs)

DSMBs play an essential role in protecting the safety of participants, and assuring integrity of the study. They accomplish the former by being familiar with the protocol, proposing appropriate analyses, and periodically reviewing the developing outcome and safety data. They accomplish the latter by reviewing data on such aspects as participant enrollment, site visits, study procedures, forms completion, data quality, losses to follow-up, and other measures of adherence to protocol. The DSMB makes recommendations based on those data, regarding appropriate protocol and operational changes. DSMBs (and the investigators) monitor toxicity and discuss any concern in this regard. The DSMB monitoring function is above and beyond the oversight traditionally provided by IRBs and as such is particularly important for multicenter trials. For information on NIH guidance on when DSMBs are needed, click here.

DSMBs perform 3 fundamental functions:

• Review accumulating clinical data relating to the efficacy and safety of the investigational product (drug, biologic and/or device).
• Conduct interim analysis of the clinical data to determine whether the study needs to be terminated for safety reasons.
• Ensure the continued scientific validity and merit of the study.

DSMBs monitoring interventional trials should perform the following activities:

• Review the research protocol and plans for data and safety monitoring.
• Evaluate the progress of interventional trial(s), including periodic assessments of data quality and timeliness, participant recruitment, accrual and retention, participant risk versus benefit, performance of trial sites, and other factors that can affect study outcome. Monitoring should also consider factors external to the study when interpreting the data, such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the study.
• Make recommendations to the IRB and investigators concerning continuation or conclusion of the trial.
• Protect the confidentiality of the trial data and the results of monitoring.

The DSMB should have written operating procedures and maintain records of all its meetings, including interim results. The meeting frequency of a DSMB, its composition, and its responsibilities should be tailored to the design and risks of each study.

Membership DSMBs (typically 3-9 members) usually consist of clinicians who are experts in the particular clinical area under study, and biostatisticians who understand the statistical methods used to analyze the study data and are able to draw a conclusion based on the information. In some cases, DSMBs also may include medical ethicists, which serve as advocates for the research subject, as well as pharamacologists, epidemiologists or toxicologists. Unlike IRBs, which primarily review informed consent, human subject safety and study design issues before the study begins, DSMB review is ongoing and designed to determine whether study changes or termination are needed as a study proceeds. The DSMB is separate from an IRB. Board appointments are fixed terms.

If there is a sponsor or representative of a funding agency on a DSMB, their role should be clearly defined in the operating procedures of the committee (i.e. whether or not they can vote on key issues). Since the sponsor staff would have access to unblinded information, the procedures should also address the control of dissemination of interim study results within the sponsor/funding organization.

A DSMP should identify the DSMB (not members’ names) and include a brief description of the monitoring plan as well as procedures for transmitting the DSMB’s summary reports to the IRB.