Single‐arm phase II trial design under parametric cure models | Zendy

Wu Jianrong | Zendy

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Single‐arm phase II trial design under parametric cure models

Author(s) -

Wu Jianrong

Publication year - 2015

Publication title -

pharmaceutical statistics

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.421

H-Index - 38

eISSN - 1539-1612

pISSN - 1539-1604

DOI - 10.1002/pst.1678

Subject(s) - sample size determination , parametric statistics , statistic , phase (matter) , exponential function , computer science , parametric model , statistics , mathematics , mathematical analysis , chemistry , organic chemistry

The current practice of designing single‐arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single‐arm phase II trials under the parametric cure model. In this paper, a test statistic is proposed, and a sample size formula is derived for designing single‐arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios. Copyright © 2015 John Wiley & Sons, Ltd.

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