A two-stage design for phase II trials with time-to-event endpoint using restricted follow-up.

ABSTRACT: In phase II oncology trials, the use of new cytostatic drugs raises some questions regarding the endpoint. Time-to-event endpoints such as Progression-Free Survival have been recommended and led to new designs. In 2003, Case and Morgan proposed a design based on the comparison of the cumulative hazards at a clinically relevant timepoint. In 2013, Kwak proposed a design based on the one-sample log-rank test. If all the patients are followed from their entry time to the analysis date, the Kwak and Jung's design leads to a smaller sample size as compared to the Case-Morgan's design. However, the Case and Morgan's design requires less information since it only needs to follow every patient during a fixed interval of time. We propose a trade-off between these two approaches that corresponds to

SUBMITTER: Belin L 

PROVIDER: S-EPMC5898579 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature