Conditional Analysis and Unconditional Conclusion in Clinical Trial with Interim Analysis

Xi Chen
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Xi Chen: PharmClint Co. Ardsley, USA

Biostatistics and Biometrics Open Access Journal, 2018, vol. 8, issue 3, 44-50

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.

Keywords: Biometrics Open Access Journal; Biostatistics and Biometrics; Biostatistics and Biometrics Open Access Journal; Open Access Journals; biometrics journal; biometrics articles; biometrics journal reference; biometrics journal impact factor; biometrics and biostatistics journal impact factor; journal of biometrics; open access juniper publishers; juniper publishers reivew (search for similar items in EconPapers)
Date: 2018
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Persistent link: https://EconPapers.repec.org/RePEc:adp:jbboaj:v:8:y:2018:i:3:p:44-50

DOI: 10.19080/BBOAJ.2018.08.555736

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