Master Protocol Clinical Trials for Evidence Generation: Strategies, Designs, Operations, and Case Studies (Chapman & Hall/CRC Biostatistics Series)

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, economic insights and patients perspectives.It examines both opportunities and challenges in