Data Monitoring Committees (DMCs), also sometimes called Data and Safety Monitoring Boards (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 DMC makes recommendations based on those data, regarding appropriate protocol and operational changes. DMCs (and the investigators) monitor toxicity and discuss any concern in this regard. The DMC monitoring function is above and beyond the oversight traditionally provided by IRBs and as such is particularly important for multicenter trials.
Please see the NIH guidance on when DMCs are needed and the ITHS Partner Institutions Joint Tool for Data and Safety Monitoring Plans (DSMP). Additionally, ITHS, in collaboration with 8 other CTSAs has produced an online DSMB Training Manual with a focus on investigator-initiated studies. This manual provides information and training for individual members including templates, responsibilities, and activities to establish and maintain an effective DSMB.
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.
DMCs 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 DMC should have written operating procedures and maintain records of all its meetings, including interim results. The meeting frequency of a DMC, its composition, and its responsibilities should be tailored to the design and risks of each study.DMCs (typically three to nine members) usually consist of clinicians who are experts in the particular clinical area under study and a biostatistician who understands the statistical methods used to analyze the study data and is able to draw a conclusion based on the information provided. In some cases, DMCs also may include medical ethicists, which serve as advocates for the research participant, 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, DMC review is ongoing and designed to determine whether study changes or termination are needed as a study proceeds. The DMC is separate from an IRB. Committee appointments are fixed terms.
If there is a sponsor or representative of a funding agency on a DMC, 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 DMC (including specific members’ names and roles on the committee) and include a brief description of the monitoring plan as well as procedures for transmitting the DMC’s summary reports to the IRB. The detailed scope and function of the DMC should be outlined in a separate DMC charter.
The ITHS provides full DMC services including charter development, selection of committee members, member training, reports generation and other administrative support services. If you are interested in obtaining more information and/or getting a price quote, please complete the form below.
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