Single-arm phase II trial design under parametric cure models.
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ABSTRACT:
SUBMITTER: Wu J
PROVIDER: S-EPMC4667689 | biostudies-literature | 2015 May-Jun
REPOSITORIES: biostudies-literature
Publications
Single-arm phase II trial design under parametric cure models.
Pharmaceutical statistics 20150401 3
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 simulat ...[more]
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