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The draft adaptive design guidance released by FDA in 2010 included references to adaptive study designs that were described as "less well-understood." At that time, there was relatively little regulatory experience with such designs, and their properties were felt to be insufficiently understood. In order to promote greater use of adaptive designs, especially those categorized as less wellunderstood, the Best Practice Subteam of the DIA Adaptive Designs Scientific Working Group (ADSWG) has worked on describing and characterizing these designs, identifying challenges associated with them and suggesting improvements to design or study conduct aspects that might make them more acceptable. This paper summarizes the work from the subteam. [ABSTRACT FROM AUTHOR]

There is great potential for clinical trials designed with adaptive features to result in more efficient decision making within a drug development program. However, 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 execution may result in human and material wastes. Further, they may result in the introduction of operational biases that may potentially negate any gains in designing an AD trial and may even render trial results not interpretable. In this article, we present and share our experience and best practices in AD trial implementation in the areas of resource planning, randomization considerations including the importance of randomization schemes on clinical supply, Interactive Voice Randomization System vendor capability assessment and quality control, clinical supply strategy considerations, enrollment management and patient enrollment modeling and simulation, data quality and interim analysis planning, managing blinding and unblinding, and the use of a data monitoring committee. [ABSTRACT FROM AUTHOR]