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- Title
Single-arm phase II trial design under parametric cure models.
- Authors
Wu, Jianrong
- Abstract
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.
- Subjects
CLINICAL trials -- Social aspects; EXPONENTIAL functions; MEDICAL care; POPULATION statistics; SIMULATION methods &; models
- Publication
Pharmaceutical Statistics, 2015, Vol 14, Issue 3, p226
- ISSN
1539-1604
- Publication type
Article
- DOI
10.1002/pst.1678