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Abstract:
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Often, a waiting time from the moment when the number of subjects required for an interim analysis (IA) is enrolled in a study to the time when a decision based IA results is actually implemented is a major hurdle reducing applicability of adaptive designs. At the same time, the adaptive designs are essential components of clinical development strategies worthy of considerations, as they naturally belong to a stage-wise investment paradigm intended to de-risk the program. This presentation would discuss some techniques that mitigate the challenge of the delayed IA decision in a context of a case study clinical program, e.g., aggregation information from multiple ongoing studies and use of partial data from subjects not reaching primary endpoint at the time of IA.
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