Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility

Abstract

The traditional Simon’s two-stage design for phase IIA clinical trials is modified to enhance the flexibility in conducting the interim analysis and sample size adjustment. The modification is based on the well-established methodology in adaptive designs using the conditional probability and allows for early termination as well as extension with sample size adjustment. The dynamic data monitoring system is naturally suitable for basket trials where several tumor types are monitored simultaneously with different enrollment rates.