Role of the Data Monitoring Committee and Sponsor in Monitoring Adaptive Designs
Clinical Data Management
Andreas Sashegyi, Ph.D. Research Advisor, Decision Sciences Group Eli Lilly and Company
Summary
Over the past two decades, the use of independent Data Monitoring Committees (DMCs) to monitor accruing data of especially large, long-term clinical trials has become commonplace. This construct importantly allows rigorous oversight of the safety of patients during the conduct of a trial, while allowing the trial sponsor to remain blinded to accumulating data, and hence, helping to preserve the scientific integrity of the study. More recently, clinical drug development is beginning to witness the substantial leveraging of adaptive trial designs that promise to deliver attractive and much needed efficiencies to the pharmaceutical R&D enterprise. The use of these adaptive designs is more complex than traditional fixed-design
alternatives; in particular, their very nature implies that critical decision points may be encountered during the trial's conduct. This raises the question of whether and how the sponsor may play a greater role in the monitoring of and decision making for adaptive designs, and how an independent DMC can be leveraged, especially for pivotal trials, through an expanded frame of responsibilities in order to maintain the protection of patient safety and trial integrity. This article provides some guidelines to address these questions, and describes a sample DMC construct for a seamless Phase 2/3 trial.
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