|
Abstract:
|
Since the NEJM publication in 2017 and FDA guidance in 2019, master protocol, an innovative clinical trial design strategy, has gained increasing popularity in clinical trial development. Numerous publications and a growing number of new studies start to follow the master protocol framework. At the same time, innovative statistical methods have been proposed and developed to accommodate unique challenges in master protocol designs. The ASA oncology WG master protocol subteam is conducting a survey in multiple pharmaceutical companies and non-profit organizations across the industry to understand the current trend and perception on the applications of master protocol framework across various disease areas, potential barriers and solutions, and practical and regulatory considerations. In this presentation, we provide survey results, as well as showcase some unique aspects when designing and conducting master protocol trials with examples.
|
