Single-Arm Phase II Group Sequential Trial Design With Survival Endpoint at a Fixed Time Point

Jianrong Wu; Xiaoping Xiong

doi:10.1080/19466315.2014.923325

Single-Arm Phase II Group Sequential Trial Design With Survival Endpoint at a Fixed Time Point

Jianrong Wu, Xiaoping Xiong

Internal Medicine

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

In this article, three nonparametric test statistics are proposed to design single-arm phase II group sequential trials for monitoring survival probability. The small-sample properties of these test statistics are studied through simulations. Sample size formulas are derived for the fixed sample test. The Brownian motion property of the test statistics allowed us to develop a flexible group sequential design using a sequential conditional probability ratio test procedure. An example is given to illustrate the trial design by using the proposed method.

Original language	English
Pages (from-to)	289-301
Number of pages	13
Journal	Statistics in Biopharmaceutical Research
Volume	6
Issue number	4
DOIs	https://doi.org/10.1080/19466315.2014.923325
State	Published - Oct 2 2014

Bibliographical note

Publisher Copyright:
© 2014, © American Statistical Association Statistics in Biopharmaceutical Research.

Keywords

Brownian motion
Interim analysis
Nelson–Aalen estimate
Sample size
Single-arm phase II trial
Survival probability

ASJC Scopus subject areas

Statistics and Probability
Pharmaceutical Science

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10.1080/19466315.2014.923325

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title = "Single-Arm Phase II Group Sequential Trial Design With Survival Endpoint at a Fixed Time Point",

abstract = "In this article, three nonparametric test statistics are proposed to design single-arm phase II group sequential trials for monitoring survival probability. The small-sample properties of these test statistics are studied through simulations. Sample size formulas are derived for the fixed sample test. The Brownian motion property of the test statistics allowed us to develop a flexible group sequential design using a sequential conditional probability ratio test procedure. An example is given to illustrate the trial design by using the proposed method.",

keywords = "Brownian motion, Interim analysis, Nelson–Aalen estimate, Sample size, Single-arm phase II trial, Survival probability",

author = "Jianrong Wu and Xiaoping Xiong",

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AU - Xiong, Xiaoping

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N2 - In this article, three nonparametric test statistics are proposed to design single-arm phase II group sequential trials for monitoring survival probability. The small-sample properties of these test statistics are studied through simulations. Sample size formulas are derived for the fixed sample test. The Brownian motion property of the test statistics allowed us to develop a flexible group sequential design using a sequential conditional probability ratio test procedure. An example is given to illustrate the trial design by using the proposed method.

AB - In this article, three nonparametric test statistics are proposed to design single-arm phase II group sequential trials for monitoring survival probability. The small-sample properties of these test statistics are studied through simulations. Sample size formulas are derived for the fixed sample test. The Brownian motion property of the test statistics allowed us to develop a flexible group sequential design using a sequential conditional probability ratio test procedure. An example is given to illustrate the trial design by using the proposed method.

KW - Brownian motion

KW - Interim analysis

KW - Nelson–Aalen estimate

KW - Sample size

KW - Single-arm phase II trial

KW - Survival probability

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ER -

Single-Arm Phase II Group Sequential Trial Design With Survival Endpoint at a Fixed Time Point

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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