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Conditional Analysis and Unconditional Conclusion in Clinical Trial with Interim Analysis

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  • Xi Chen

    (PharmClint Co. Ardsley, USA)

Abstract

In the statistical analysis of a clinical trial with interim analysis, few of the currently existing methodology has ever presented a complete set of the assumptions and the rationale for these assumptions. The design of the trial with interim analysis is based on a conditional analysis, but the trial conclusion is completely unconditional. A linkage between the conditional analysis and the unconditional conclusion is mandatory for a complete set of the trial analysis. The purpose of this manuscript is to outline some basic research ideas against the current practice and the practical considerations which may lead to a feasible solution to this kind of analysis. The example shows that depends upon the algorithm for hypothesis tests, the error inflation caused by repeated significance test may not exist.

Suggested Citation

  • Xi Chen, 2018. "Conditional Analysis and Unconditional Conclusion in Clinical Trial with Interim Analysis," Biostatistics and Biometrics Open Access Journal, Juniper Publishers Inc., vol. 8(3), pages 44-50, October.
    • Handle: RePEc:adp:jbboaj:v:8:y:2018:i:3:p:44-50
    DOI: 10.19080/BBOAJ.2018.08.555736
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