Journal of biopharmaceutical statistics
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Parameter estimation following an adaptive design or group sequential design has been extremely challenging due to potential random high from its face value estimate. In this paper, we introduce a new framework to model clinical trial data flow based on a marked point process (MPP). ⋯ As an example, we apply this method to a two stage treatment selection design and derive a procedure to estimate the treatment effect. Numerical examples will be used to evaluate the performance of the proposed procedure.