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Session 3: Case Study 1: Master Protocol Implementation in Oncology
Session Chair(s)
Lisa Rodriguez, PHD
Deputy Division Director, OB, OTS, CDER, FDA, United States
This next two sessions will showcase two compelling case studies highlighting innovative approaches to clinical trial design and execution. Each case study provides a deep dive into real-world applications, focusing on the challenges, solutions, and outcomes of cutting-edge methodologies in diverse therapeutic areas.
Case Study 1 will discuss Master protocol in oncology. A practical example of effective master protocol design and execution will be presented. Regulatory opinions on implementation and evaluation will also be discussed.
Learning Objective : - Understand the principles and benefits of master protocol designs and how they are applied in oncology trials
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Identify innovative trial design strategies in neuroscience
- Apply key learnings from these case studies to inform the design and execution of future clinical trials in your own therapeutic areas
Speaker(s)
Timothy Cloughesy, MD
Professor of Neurology, Director, UCLA Brain Tumor Center, UCLA, United States
Speaker
Xiaoxue Li, PHD
Lead Mathematical Statistician, FDA, United States