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When designing clinical trials, researchers often encounter the uncertainty in the treatment effect or variability assumptions. Hence the sample size calculation at the planning stage of a clinical trial may also be questionable. Adjustment of the sample size during the mid-course of a clinical trial has become a popular strategy lately. In this paper we propose a procedure for calculating additional sample size needed based on conditional power, and adjusting the final-stage critical value to protect the overall type-I error rate. Compared to other previous procedures, the proposed procedure uses the definition of the conditional type-I error directly without appealing to an extra special function for it. It has better flexibility in setting up interim decision rules and the final-stage test is a likelihood ratio test.
Gengxu Li (Sat,) studied this question.