Lu Qingshu, Chow Shein Chung, Tse Siu Keung, Chi Yunchan, Yang Lan Yan
Department of Statistics & Finance, University of Science and Technology of China, Anhui, China.
J Biopharm Stat. 2009;19(2):311-23. doi: 10.1080/10543400802622527.
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.
