387 – Statistical Issues in Oncology Clinical Trials: Progression-Free Survival and Overall Survival
Advanced Application of Using Progression-Free Survival to Make Optimal Go-No Go Decision in Oncology Drug Development
Cong Chen
Merck
Zhiping Sun
Merck
Seamless Ph2/3 design holds the promise to accelerate an oncology drug development program. However, the Go-No Go (GNG) decision from Ph2 to Ph3 transition has to be made with limited clinical endpoint data. The difficulty to pre-specify such a decision rule is arguably the single most important reason why seamless designs are less used in practice than expected. In this presentation, we'd like to address the following issues: 1) how to effectively incorporate surrogate biomarker (e.g. PFS) data into the decision criteria; 2) how to derive objective GNG bars from a benefit-cost ratio perspective to streamline the decision making process; 3) how to fully realize the potential of a seamless design with proper risk mitigation. Our work is based on a real example in the oncology therapeutic area. However, the general approach is equally applicable to various other areas.
