Dynamic comparison of Kaplan-Meier proportions: monitoring a randomized clinical trial with a long-term binary endpoint.

Abstract:

:The approach to early termination for efficacy in a trial where events occur over time but the primary question of interest relates to a long-term binary endpoint is not straightforward. This article considers comparison of treatment groups with Kaplan-Meier (KM) proportions evaluated at increasing times from randomization, at increasing calendar testing times. This strategy is employed to improve the ability to detect important treatment effects and provide critical treatments to patients in a timely manner. This dynamic Kaplan-Meier (DKM) approach is shown to be robust; that is, it produces high power and early termination time across a wide range of circumstances. In contrast, a fixed time KM comparison and the log-rank test are both shown to be more variable in performance. Practical considerations of implementing the DKM method are discussed.

journal_name

Biometrics

journal_title

Biometrics

authors

Brittain E,Follmann D,Yang S

doi

10.1111/j.1541-0420.2007.00874.x

subject

Has Abstract

pub_date

2008-03-01 00:00:00

pages

189-97

issue

1

eissn

0006-341X

issn

1541-0420

pii

BIOM874

journal_volume

64

pub_type

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