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Activity Number: 44
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317212
Title: Stopping for Futility on Progression-Free Survival in Oncology Clinical Trials
Author(s): Qiming Liao*
Companies: GlaxoSmithKline
Keywords:
Abstract:

Progression-free survival (PFS) is often used as the primary efficacy endpoint in oncology clinical trials. The PFS is defined as the length of time between the date of starting treatment and the earliest date of disease progression or death due to any cause. If a patient does not have a documented date of progression or death, then PFS is censored at the date of last adequate assessment. We introduce a new study design in which the PFS is the primary endpoint and interim analyses are planned to evaluate the futility based on an initial group of subjects at an earlier time point and, if the study continues after the first interim analysis, the superiority based on the full sample of subjects but with shorter than planned follow-up time. The criteria on stopping for futility based on conditional probability are specified, and the stopping hazard ratio boundary and sample size for futility analysis are calculated using simulation. Power and type I error preservation based on sequential data monitoring are also discussed.


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