Statistics in Clinical Development of Cancer Drugs: Recent Trends & Advances (IISA Series on Statistics and Data Science)

Cancer clinical trials have become increasingly complex, requiring statistical methodologies that are both rigorous and flexible across diverse study designs.This book provides a comprehensive and practice-oriented overview of the statistical methods underpinning modern oncology drug development, covering the full continuum from early-phase studies through confirmatory trials and regulatory submission. Organized by development phase, the text presents principled approaches to dose-escalation and dose-optimization, proof-of-concept decision-making, and master protocol designs.It further details methodologies for late-stage trials, including sample size determination, group-sequential monitoring, time-to-event analysis, multiplicity adjustment, and adaptive designs, with particular attention to challenges such as delayed treatment effects. In addition to confirmatory trial methodology, the book addresses advanced analytical topics, including subgroup evaluation, treatment switching, mult