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

Producción científica: Article › revisión exhaustiva

3 Citas (Scopus)

Resumen

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.

Idioma original	English
Páginas (desde-hasta)	289-301
Número de páginas	13
Publicación	Statistics in Biopharmaceutical Research
Volumen	6
N.º	4
DOI	https://doi.org/10.1080/19466315.2014.923325
Estado	Published - oct 2 2014

Nota bibliográfica

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

Financiación

The work was supported in part by National Cancer Institute (NCI) support grant CA21765 and the American Lebanese Syrian Associated Charities (ALSAC).

Financiadores	Número del financiador
National Childhood Cancer Registry – National Cancer Institute	CA21765
Lebanese American University

ASJC Scopus subject areas

Statistics and Probability
Pharmaceutical Science

Acceder al documento

10.1080/19466315.2014.923325

Otros archivos y enlaces

Citar esto

@article{57bc9809c29c49a3b1bdf389f4d69ee7,

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{\textendash}Aalen estimate, Sample size, Single-arm phase II trial, Survival probability",

author = "Jianrong Wu and Xiaoping Xiong",

note = "Publisher Copyright: {\textcopyright} 2014, {\textcopyright} American Statistical Association Statistics in Biopharmaceutical Research.",

year = "2014",

month = oct,

day = "2",

doi = "10.1080/19466315.2014.923325",

language = "English",

volume = "6",

pages = "289--301",

number = "4",

}

TY - JOUR

T1 - Single-Arm Phase II Group Sequential Trial Design With Survival Endpoint at a Fixed Time Point

AU - Wu, Jianrong

AU - Xiong, Xiaoping

PY - 2014/10/2

Y1 - 2014/10/2

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

UR - https://www.scopus.com/pages/publications/84926032751

UR - https://www.scopus.com/pages/publications/84926032751#tab=citedBy

U2 - 10.1080/19466315.2014.923325

DO - 10.1080/19466315.2014.923325

M3 - Article

AN - SCOPUS:84926032751

VL - 6

SP - 289

EP - 301

JO - Statistics in Biopharmaceutical Research

JF - Statistics in Biopharmaceutical Research

IS - 4

ER -

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

Resumen

Nota bibliográfica

Financiación

ASJC Scopus subject areas

Acceder al documento

Otros archivos y enlaces

Huella

Citar esto