Statistics in Clinical Development of Cancer Drugs
Recent Trends & Advances
Series: IISA Series on Statistics and Data Science;
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Product details:
- Publisher Springer Nature Singapore
- Date of Publication 20 August 2026
- ISBN 9789819595174
- Binding Hardback
- No. of pages529 pages
- Size 235x155 mm
- Language English
- Illustrations VIII, 529 p. 56 illus., 34 illus. in color. 700
Categories
Long description:
"
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, multi-phase treatment strategies, and bias adjustment techniques. Contemporary issues in oncology research?such as the estimand framework, real-world evidence, seamless and platform trials, and emerging applications of artificial intelligence and machine learning?are also discussed.
Accessible yet rigorous, this book is an essential resource for biostatisticians, clinical researchers, and graduate students who want to design smarter trials, make better decisions, and accelerate the development of life-saving cancer therapies.
" MoreTable of Contents:
Section 1: Introduction.- Chapter 1: Overview of cancer trials.- Chapter 2: Application of Estimands framework.- Section 2: Statistical methods for Early phase trials.- Chapter 3: Dose-escalation designs.- Chapter 4: Proof-of-concept and Dose-optimization designs.- Section 3: Late phase.- Chapter 5: Designing pivotal cancer trial along with sample size.- Chapter 6: Complex designs.- Chapter 7: Non-proportionality and other challenges related to immunotherapy.- Chapter 8: Post-hoc analyses (specific to time-to-event endpoint).- Section 4: Additional topics.- Chapter 9: Quantitative decision making and Event projection.- Chapter 10: AI/ML methods and precision medicine.- Chapter 11: Basket and umbrella trials.- Appendices.
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