Advanced Clinical Trials and Clinical Research

Master Protocol Strategies

Master protocols are revolutionizing clinical research by enabling the simultaneous evaluation of multiple interventions under a unified trial framework. This session covers the three main types of master protocols: basket, umbrella, and platform trials. Experts will explain how these designs can reduce duplication, optimize patient stratification, and accelerate therapeutic development, especially in oncology and infectious disease. Topics include protocol planning, operational execution, statistical modeling, and regulatory alignment. Attendees will examine real-world examples such as I-SPY, REMAP-CAP, and Lung-MAP, and learn how to implement master protocol infrastructure across sponsors, sites, and regulators. The session emphasizes benefits such as faster decision-making, shared control arms, and efficient resource allocation. Whether launching multi-arm studies or repurposing therapies, this session provides the strategic and technical insights needed to leverage master protocols successfully.