• J Biopharm Stat · Jan 2005

    Comparative Study

    Adaptive statistical analysis following sample size modification based on interim review of effect size.

    • H M James Hung, Lu Cui, Sue-Jane Wang, and John Lawrence.
    • Division of Biometrics I, OB/OPaSS/CDER, FDA, Rockville, Maryland, USA. hung@cder.fda.gov
    • J Biopharm Stat. 2005 Jan 1;15(4):693-706.

    AbstractIn designing a comparative clinical trial, the required sample size is a function of the effect size, the value of which is unknown and at best may be estimated from historical data. Insufficiency in sample size as a result of overestimating the effect size can be destructive to the success of the clinical trial. Sample size re-estimation may need to be properly considered as a part of clinical trial planning. This paper is intended to give the motivations for the sample size re-estimation based partly on the effect size observed at an interim analysis and for a resulting simple adaptive test strategy. The performance of this adaptive design strategy is assessed by comparing it with a fixed maximum sample size design that is properly adjusted in anticipation of the possible sample size adjustment.

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