Abstract:
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A Data Monitoring Committee (DMC) for a randomized clinical trial (RCT) is an independent group of experts, typically consisting of 3-5 members, which has a combined expertise in the disease area, clinical practice, and biostatistics. The main purpose of a DMC is to protect the interests of participating human volunteers while the trial is ongoing, through interim reviews of safety and efficacy data to assess risk-benefit and make recommendations to the sponsor regarding the study. Inherent to both the DMC's ability to carry out their duties during interim monitoring of the trial and the trial's impact on the target population are the three intrinsic components of a RCT for adequately and reliably answering the scientific questions of interest: design; conduct; and analysis. The DMC Organizational (Org, or kick-off) meeting, held before first patient screened and ideally before the protocol has been finalized, is an ideal time to review and discuss the three pillars (e.g., choice of analysis population; recruitment vs. retention vs. adherence), and if necessary make modifications as early as possible to preserve the integrity of the trial and its eventual impact on public health.
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