Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes.
Topics in this presentation include:
- Developing a framework for handling multiple endpoints for the drug’s go-to-market label
- Determining the potential of adaptive design for optimizing the trial and evaluating the applicability of various adaptive design approaches
- Key interactions and questions to ask when seeking regulatory input of pivotal study designs
Abie Ekangaki, Ph.D. Vice President, Statistical Consulting, Premier Research
Rupa Doshi, Executive Director, Program Strategy, Premier Research
Naomi Kautz, Senior Director, Regulatory Affairs, RPI, A Division of Premier Research