Survival trial design and monitoring using historical controls

Jianrong Wu; Xiaoping Xiong

doi:10.1002/pst.1756

Survival trial design and monitoring using historical controls

Jianrong Wu, Xiaoping Xiong

Internal Medicine

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

6 Scopus citations

Abstract

In this paper, we propose a multistage group sequential procedure to design survival trials using historical controls. The formula for the number of events required for historical control trial designs is derived. Furthermore, a transformed information time is proposed for trial monitoring. An example is given to illustrate the application of the proposed methods to survival trial designs using historical controls.

Original language	English
Pages (from-to)	405-411
Number of pages	7
Journal	Pharmaceutical Statistics
Volume	15
Issue number	5
DOIs	https://doi.org/10.1002/pst.1756
State	Published - Sep 1 2016

Bibliographical note

Publisher Copyright:
Copyright © 2016 John Wiley & Sons, Ltd.

Keywords

group sequential trial design
historical control
information time
log-rank test
sample size
time-to-event

ASJC Scopus subject areas

Statistics and Probability
Pharmacology
Pharmacology (medical)

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10.1002/pst.1756

Cite this

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abstract = "In this paper, we propose a multistage group sequential procedure to design survival trials using historical controls. The formula for the number of events required for historical control trial designs is derived. Furthermore, a transformed information time is proposed for trial monitoring. An example is given to illustrate the application of the proposed methods to survival trial designs using historical controls.",

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AB - In this paper, we propose a multistage group sequential procedure to design survival trials using historical controls. The formula for the number of events required for historical control trial designs is derived. Furthermore, a transformed information time is proposed for trial monitoring. An example is given to illustrate the application of the proposed methods to survival trial designs using historical controls.

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KW - information time

KW - log-rank test

KW - sample size

KW - time-to-event

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Survival trial design and monitoring using historical controls

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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