A1071
Title: Determining a follow-up period for cure rate estimation in an exploratory phase clinical trial
Authors: Yumiko Ibi - Kyoto University Hospital (Japan) [presenting]
Yuka Sano - Kyoto University (Japan)
Tosiya Sato - Kyoto University (Japan)
Kentaro Ueno - Kyoto University Hospital (Japan)
Takashi Omori - Kyoto University (Japan)
Abstract: In the development of cancer immunotherapy, the number of long-term survivors who will never experience the event of interest and are considered cured is increasing. The cure rate, which is defined as the proportion of long-term survivors, may be an important metric for patients to make treatment decisions. Therefore, it is important to properly determine a follow-up period time for the cure rate estimation before proceeding to a confirmatory clinical trial. The purpose is to propose a method of determining the follow-up time in cancer clinical trials for the proper estimation of the cure rate and to evaluate the proposed method using the Kaplan-Meier estimator and its corrected estimator.