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Optimizing Tests about Survival Probabilities in the One-Arm Phase II Cancer Clinical Trial Setting

Author

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  • Alan D Hutson

    (Department of Biostatistics & Bioinformatics, Roswell Park Cancer Institute, USA)

  • William E Brady

    (Department of Biostatistics & Bioinformatics, Roswell Park Cancer Institute, USA)

Abstract

In this note, we examine the effect of the choice of the time point, t, at which to dichotomize time-to-event endpoints in single-arm, phase II, oncology clinical trials. These trials routinely treat these endpoints as binomial random variables, but there has been no examination of the effect of the choice of t on the trial’s design and operating characteristics, including type I error rate control, sample size and power, and total study duration (accrual plus follow-up time).

Suggested Citation

  • Alan D Hutson & William E Brady, 2017. "Optimizing Tests about Survival Probabilities in the One-Arm Phase II Cancer Clinical Trial Setting," Biostatistics and Biometrics Open Access Journal, Juniper Publishers Inc., vol. 2(2), pages 30-37, July.
    • Handle: RePEc:adp:jbboaj:v:2:y:2017:i:2:p:30-37
    DOI: 10.19080/BBOAJ.2017.02.555582
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