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
Biometricsjournal_title
Biometricsauthors
Brittain E,Follmann D,Yang Sdoi
10.1111/j.1541-0420.2007.00874.xsubject
Has Abstractpub_date
2008-03-01 00:00:00pages
189-97issue
1eissn
0006-341Xissn
1541-0420pii
BIOM874journal_volume
64pub_type
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