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Activity Number: 610
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract #315953 View Presentation
Title: Single-Arm Phase II Trial Design Under Parametric Cure Models
Author(s): Jian Rong Wu*
Companies: St. Jude Children's Research Hospital
Keywords: Clinical trial design ; Cure model ; Time-to-evnet ; Sample size ; Single-arm phase II trial
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 article, 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.

Authors who are presenting talks have a * after their name.

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