All Times EDT
Keywords: dose optimization, phase I-II design, optimal biological dose
In the era of targeted therapy, there has been increasing concern about the development of oncology drugs based on the “more is better” paradigm, developed decades ago for chemotherapy. FDA initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development. In this talk, we will review the phase I-II design paradigm, which provide a unified framework for dose optimization. A number of design examples will be used to illustrate the key components of the paradigm, including endpoints, benefit-risk criterion, statistical model, and adaptive decision rule. Real-world trial examples and software will be provided to illustrate the designs and paradigm.