Master Protocol Clinical Trials for Evidence Generation Strategies, Designs, Operations, and Case Studies

Drug development is at a crossroads. As personalized medicine and targeted therapies expand, traditional clinical trial models have become too slow, costly, and inefficient. To meet the urgent need for faster, reliable evidence generation and decision making, researchers and regulators alike have turned to innovative trial designs. Among these, master protocols stand out as a transformative approach, allowing multiple therapies, disease subtypes, or objectives to be studied under a single, integrated framework. Proven successful in oncology, COVID-19, and beyond, they improve efficiency, reduce participant exposure to ineffective treatments, and accelerate meaningful outcomes with patient-centric approach, prompting regulatory guidance and global adoption. This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, and economic insights, as well as patients' perspectives. It examines both opportunities and challenges in design and implementation, and provides an in-depth summary and discussion on real-world examples such as I-SPY2, ROAR, and RECOVERY. A practical guide for clinical trialists, drug developers, researchers, statisticians, regulators, and industry professionals, it demonstrates how master protocols can reshape drug development and bring innovative therapies to patients faster.

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