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Full Description
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 design and implementation, and provides in-depth summary and discussion on real-world examples such as I-SPY, ROAR, and RECOVERY. A practical guide for researchers, statisticians, regulators, and industry professionals, it demonstrates how master protocols can reshape drug development and bring innovative therapies to patients faster.
● Provides comprehensive, theoretical and practical aspects for master protocol trials
● Includes most recent development in the master protocol clinical trials
● Covers broad topics such as trial designs, governance oversight, software implementation, database and data pipeline, multi-regional trials, risk and benefit with operational solutions, economic considerations, regulatory perspectives, patient engagement and diversity
● Deep dives into numerous real world case studies, their underlying thinking, challenges and success.
● Includes global perspective in multi-regional clinical development
Contents
Editors Biographies List of contributors Part 1: Overview and introduction 1 Introduction to Master Protocols Trials: Definition, Design, and Data 2 Regulatory Landscape 3 Current Applications of Master Protocol Trials Part 2: Design, methodologies, and strategy 4 Basket Trials: Exploratory and Confirmatory 5 Statistical Considerations for Designing and Analyzing Platform Trials 6 Master Protocols for Multiple-Regional Clinical Trials 7 Randomized Screening Selection Design for Pediatric Oncology Trials 8 Master Protocols using External Data and Real-World Evidence 9 Safety and Benefit-Risk Assessment in Master Protocols 10 DRAFT_Bayesian Adaptive Design and Interim Decision Making 11 Holistic Decision-Making for Master Protocols Part 3: Implementation, patient engagement, and economic evaluation 12 Economic Considerations of Platform Trials for Clinical Development Programs in Multi-Sponsor and Single-Sponsor Settings 13 Data Monitoring Committee Establishment and Operation 14 onsiderations on Regulatory, IRB, Ethics Committee Interactions and Related Challenges 15 Implementation of Software for Design and Simulation of Platform Trials 16 Patient Engagement in Master Protocols Appendix_Framework to include PE in clinical trials and MPs 17 Patient Representation and Accessibility in Master Protocols Part 4: Case studies 18 I-SPY2 Case Study: Design, Data, and Innovations 19 Case Studies with Rare BRAF V600E Mutations: Basket Design Trials 20 The RECOVERY Trial - A Paradigm for Master Protocol and Platform Trial Implementation Index
