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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)
Speaker
Timothy Cloughesy, MD
UCLA, United States
Professor of Neurology, Director, UCLA Brain Tumor Center
Xiaoxue Li, PhD
FDA, United States
Lead Mathematical Statistician