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TWO FACTORS IMPACTING FORMULATION OF DATA MONITORING COMMITTEE RECOMMENDATIONS FOR ADAPTIVE DESIGN CLINICAL TRIALS

Primary: Navneet R. Hakhu
Author(s): Navneet R. Hakhu
Axio Research, LLC

SCT Annual Meeting 2018

Abstract:
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. Pre-specified monitoring guidelines (also called 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. However, not all clinical trials have monitoring guidelines; but should they? 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 two factors: (1) the types of boundaries pre-specified; and (2) the information to be conveyed to the sponsor. I will consider the following questions which pertain to the DMC’s efforts of protecting patients’ interests and preserving integrity of monitored trials: Are these ‘hard’ or ‘soft’ boundaries (i.e. truly guidelines)? What information should be conveyed as part of the DMC’s recommendations to the appropriate sponsor representative(s)? How might these boundaries differ in the setting of non-inferiority trials? What are any additional considerations for program-wide DMCs (single DMC monitoring multiple trials for the same investigational product)?

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