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Planning the duration of a survival group sequential trial with a fixed follow-up time for all subjects

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ABSTRACT To explore the operation characteristics of survival group sequential trials with a fixed follow-up period, the accrual time and total trial duration to ensure power and type I error… Click to show full abstract

ABSTRACT To explore the operation characteristics of survival group sequential trials with a fixed follow-up period, the accrual time and total trial duration to ensure power and type I error rate requirements are explained and investigated for hazard ratios ranging from 1.3 to 3.0, with slow or high accrual rate, and in the presence or absence of censoring. Impacts of hazard rate, accrual rate, and competitive censoring on accrual time and subsequently on total trial duration are carefully illustrated. Real time for interim analyses, needed number of events, and recruited number of subjects at time of interim analyses are also tabulated.

Keywords: trial; duration; survival group; time; group sequential; fixed follow

Journal Title: Communications in Statistics - Theory and Methods
Year Published: 2017

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