Sample size estimation based on event data for a two-stage survival adaptive trial with different durations.
In clinical development, an adaptive design combining results from two separate studies (e.g., a seamless adaptive design with a dose finding study phase and a confirmatory study phase) is commonly considered. The purpose of an adaptive design is not only to reduce lead time between the two studies, but also to evaluate the treatment effect in a more efficient way. In this paper, the focus is on the case where the study objectives are the same but the time durations of the study periods are different in the two stages. In particular, event data are collected in both stages. Statistical procedure for combining data observed from the two different stages is discussed. Furthermore, results on hypotheses testing and sample size calculation are derived for the comparison of two treatments.
Lu
Qingshu
Q
Department of Statistics & Finance, University of Science and Technology of China, Anhui, China.
Chow
Shein Chung
SC
Tse
Siu Keung
SK
Chi
Yunchan
Y
Yang
Lan Yan
LY
D000465:Algorithms; D015415:Biomarkers; D015233:Models, Statistical; D012107:Research Design; D018401:Sample Size; D016019:Survival Analysis
D015415:Biomarkers