Audience Discussion: Evolving Protocols in Real Time – How Are You Responding to a Changing Standard of Care?
- Are you actively adapting trial protocols to incorporate newly approved therapies, or maintaining original designs to preserve data integrity?
- How are sponsor teams responding to pressure from investigators and patients to allow background therapies?
- Looking ahead to Phase III, will flexible, adaptive protocols become the norm, or is there still a place for tightly controlled study designs?