Practical Considerations for Adaptive Design Trial Execution
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*Weili He, Merck & Co., Inc 

Keywords: adaptive design, operational bias

Clinical trials with adaptive features are more complex to implement than traditional designs such as fixed-sample or group sequential. Workarounds and/or inefficiencies in adaptive design (AD) trial implementations may result in human and material wastes or even in the introduction of operational biases that may potentially negate any gains we have in designing an AD trial and may even result in trial results that are not interpretable due to operational biases. In this presentation, we will present and share our experience in AD trial implementations in the areas of randomization considerations, IVRS vendor capability assessment and quality control, clinical supply strategy considerations, enrollment management and patient enrollment modeling and simulation, interim analysis planning, as well as blinding and unblinding management and the use of DMC.