Group sequential design for historical control trials using error spending functions

Jianrong Wu; Yimei Li

doi:10.1080/10543406.2019.1684305

Group sequential design for historical control trials using error spending functions

Jianrong Wu, Yimei Li

Internal Medicine

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

2 Scopus citations

Abstract

Group sequential designs using Lan-DeMets error spending functions are proposed for historical control trials with time-to-event endpoints. Both O’Brien–Fleming and Gamma family types of sequential decision boundaries are derived based on sequential log-rank tests, which follow a Brownian motion in a transformed information time. Simulation results show that the proposed group sequential designs using historical controls preserve the overall type I error and power.

Original language	English
Pages (from-to)	351-363
Number of pages	13
Journal	Journal of Biopharmaceutical Statistics
Volume	30
Issue number	2
DOIs	https://doi.org/10.1080/10543406.2019.1684305
State	Published - Mar 3 2020

Bibliographical note

Publisher Copyright:
© 2019, © 2019 Taylor & Francis Group, LLC.

Keywords

Error spending function
decision boundaries
group sequential design
historical control
information time

ASJC Scopus subject areas

Statistics and Probability
Pharmacology
Pharmacology (medical)

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10.1080/10543406.2019.1684305

Cite this

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Group sequential design for historical control trials using error spending functions

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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