Master Protocol Clinical Trials for Evidence Generation

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

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• Biologia, ciências da vida
• Tecnologia farmacêutica
• Probabilidade e Estatística
• Os ensaios clínicos

platform trial methodology;adaptive clinical design;regulatory science;real-world evidence analysis;patient engagement strategies;oncology trial innovation;multi-sponsor drug development case studies