Data monitoring committee

Data Monitoring Committee (DMC), also known as Data and Safety Monitoring Board (DSMB), is a group of independent experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.

Role and Responsibilities

The primary role of a DMC is to ensure the safety of trial participants and the validity and integrity of data in a clinical trial. The DMC has the authority to recommend continuation, modification, or termination of a trial based on the observed beneficial or adverse effects of the treatment under study.

The responsibilities of a DMC include:

• Reviewing the clinical trial protocol and plans for data analysis.
• Monitoring the rate of enrollment, dropout, and missing data.
• Evaluating the quality of data collected.
• Monitoring the overall conduct of the trial.
• Reviewing accumulated data from the trial and deciding whether it is ethical to continue, modify, or stop the trial.

Composition

A DMC typically consists of clinical trial experts, statisticians, and clinicians knowledgeable about the disease and treatment under study. It may also include bioethicists and patient representatives. The members should have no financial, scientific, or other conflict of interest with the trial.

Meetings

DMC meetings are usually held in private, and the frequency of meetings depends on the type of trial, the rate of enrollment, and the rate of occurrence of endpoints. The DMC reviews reports prepared by a statistical data analysis center, which is separate from the trial investigators and sponsor.

Confidentiality

The DMC has access to unblinded trial data, which must be kept confidential to maintain the integrity of the trial. The DMC's recommendations are usually communicated to the trial sponsor and investigators through a formal letter.

See Also

• Clinical trial
• Clinical trial protocol
• Statistical data analysis

Data monitoring committee Resources
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