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Abstract:
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Data Monitoring Committees (DMCs) are charged with monitoring ongoing clinical trial(s) to protect the interests of participating human volunteers and preserve trial integrity through interim reviews of safety and efficacy data. The DMC's assessment of risk-benefit forms the basis of the committee's recommendations to the sponsor to continue, stop, or modify the trial. Pre-specified monitoring guidelines (stopping boundaries) may be incorporated into an adaptive component of a trial's design for efficacy, futility, and/or safety/harm, which can facilitate the DMC's assessment. In this talk, I will focus on adaptive design clinical trials with pre-specified monitoring guidelines and how the DMC's formulation of recommendations based on a risk-benefit assessment are impacted by: 1) types of boundaries pre-specified ('hard' = must recommend stopping if boundary crossed, or 'soft' = consider recommending stopping if boundary crossed); 2) information to be conveyed to the appropriate sponsor representative; and 3) whether the DMC is monitoring a single trial or multiple trials for the same investigational product (program-wide DMCs).
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