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Abstract:
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Adaptive and other innovative trials cannot be designed without recognizing the pivotal role of clinical trial simulation to explore, compare, and understand the operating characteristics, statistical properties, as well as adaptive or other quantitative decisions embedded in the different designs. Launched in 2018, the FDA Complex Innovative Designs pilot program has brought a lot more attention to the planning and reporting of simulation studies intended to choose the ‘optimal' trial design for the objectives at hand. This presentation wants to share the results of a collaboration among industry statisticians, brought together by the DIA Innovative Design Scientific Working Group, to illustrate a unifying framework for the development of a simulation report for the design of adaptive clinical trials. This topic is even more compelling in the midst of a pandemic where innovative trials can alleviate the tension between scientific rigor in drug development and the acute urgency of a public health emergency. Clinical trial simulation must guide innovation, and innovation is a moral imperative in accelerating the process of delivering safe and effective treatments against COVID-19.
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