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Activity Number: 403 - SPAAC Poster Competition
Type: Topic Contributed
Date/Time: Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #305331
Title: Using Surrogate Endpoints for Trials with Delayed Treatment Effect
Author(s): Qing Li* and Jianchang Lin
Companies: Takeda and Takeda Pharmaceuticals
Keywords: Surrogate Endpoints; Interim Analysis; Delayed Treatment Effect; Survival Endpoints; Clinical Trial Design; Oncology

In phase III oncology studies, delayed treatment effects have often been observed. These delayed treatment effects require a long-term approach to evaluate treatment effects. In addition, these phenomena bring more challenges to the interim analysis using survival endpoints. An improper interim analysis may falsely stop a promising compound due to the late separation of survival curves. In this scenario, short-term surrogate endpoints which are believed to be predictive of the primary long-term outcome can be extremely useful. For trials with delayed treatment effect, using surrogate endpoints in the interim analysis can help make more informative Go/No Go decision based on the interim analysis results and re-estimate sample sizes during the interim analysis to maintain a high probability of success. We propose using a surrogate endpoint (e.g ORR) in the interim analysis to improve conditional power in designing adaptive sample size re-estimation trial with time-to-event endpoint (e.g PFS). Through theoretic modeling and extensive simulations, our work will demonstrate the practical feasibility and benefits of using surrogate endpoints in trials with delayed treatment effects.

Authors who are presenting talks have a * after their name.

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