Keywords: Master protocols, study design, statistical consideration, case studies
The innovative form of trial design known as a master protocol is becoming more and more popular, particularly in oncology. FDA recently released a draft guidance on master protocols. Significant progress has been made in the field establishing the design and operational practices.
This roundtable discussion is intended to discuss design considerations, statistical properties and operational challenges in master protocols. The participants are encouraged to share their experience in the use of master protocols in clinical development.
A few questions are listed below for discussion: - What are the most common designs using master protocols? - What is their utility, e.g., signal finding, registrational strategy? - What challenges have you encountered in executing master protocols? - What statistical considerations should be made when designing a master protocol? - What are the pros, cons, and lessons learned for master protocols from your experience?