| Editors | Susan Halabi, Stefan Michiels |
| Publisher | CRC Press |
| Year | 2019 |
| Language | English |
| Pages | 626 |
| Size | 13.45 MB |
| Extension |
Summary
The Textbook of Clinical Trials in Oncology: A Statistical Perspective, edited by Susan Halabi and Stefan Michiels, is a comprehensive and authoritative guide to the statistical design, conduct, and analysis of clinical trials in cancer research. Published by CRC Press in 2019 as part of the Chapman & Hall/CRC Biostatistics Series, this textbook addresses the growing demand for educational resources tailored to statisticians and clinical investigators working in oncology[reference:0][reference:1].
The book is structured to provide a sound foundation in clinical trial methodology while also covering the most advanced and innovative approaches shaping the field. It opens with an introductory chapter that sets the stage for the entire volume, discussing the general principles and challenges of clinical trials in oncology[reference:2]. The content is then organized into four major sections, each focusing on a critical phase or theme in oncology drug development[reference:3].
The first section, "Early to Middle Development," delves into the key considerations for Phase I and Phase II clinical trials[reference:4]. It covers innovative Phase I designs, current issues in Phase II cancer clinical trials, the design and analysis of immunotherapy trials, and adaptive designs[reference:5]. This section provides the essential tools for researchers working in the early stages of drug development, where dose-finding, safety, and initial efficacy signals are paramount.
The second section, "Late Phase Clinical Trials," focuses on the complexities of Phase III confirmatory studies[reference:6]. Topics include sample size calculations, non-inferiority trial design, multi-arm multi-stage trials, methods for handling multiple comparisons and multiple primary endpoints, cluster randomized trials, and statistical monitoring of safety and efficacy[reference:7]. This section equips readers with the statistical rigor needed to design and interpret large-scale, registrational trials.
The third section, "Personalized Medicine," is devoted to the cutting-edge topic of biomarker-driven clinical trials[reference:8]. It covers biomarker-based Phase II and III designs, genomic biomarker clinical trial designs, trial designs for rare diseases, statistical methods for biomarker and subgroup evaluation, and the development and validation of prognostic models[reference:9]. This section is particularly timely given the increasing importance of precision medicine in oncology.
The fourth section, "Advanced Topics," addresses sophisticated statistical methods that are essential for the analysis of modern oncology trials[reference:10]. It includes chapters on surrogate endpoints, competing risks, cure models, interval censoring, methods for analyzing trials with treatment changes, the analysis of adverse events, quality of life outcomes, and handling missing data[reference:11]. These topics provide the depth needed for researchers to tackle complex analytical challenges.
Written by a prestigious list of 52 internationally recognized contributors from both academia and the pharmaceutical industry, the book is carefully edited to ensure consistency in style, level, and approach[reference:12][reference:13]. It is expected to be extremely useful for statisticians and investigators with years of experience, as well as for future clinical researchers and statisticians eager to learn about the design, conduct, analysis, and interpretation of oncology clinical trials[reference:14].
Key Features
- Comprehensive coverage of oncology clinical trials, from early-phase through late-phase development.
- In-depth treatment of innovative Phase I and Phase II designs, including immunotherapy and adaptive trials.
- Detailed guidance on Phase III trial design, including sample size, non-inferiority, and multi-arm multi-stage trials.
- Cutting-edge coverage of precision medicine, including biomarker-driven trials and genomic biomarker designs.
- Advanced statistical methods for survival analysis, competing risks, cure models, and surrogate endpoints.
- Practical case studies that provide a "hands-on" approach to learning[reference:15].
- Real-world examples of flaws in previously reported clinical trials and strategies to avoid them[reference:16].
- Access to statistical code on the book's companion website[reference:17].
- Contributions from internationally recognized statisticians from academia and the pharmaceutical industry[reference:18].
- Carefully edited to ensure consistency in style, level, and approach[reference:19].
- Addresses trials in immune-oncology, rare diseases, and other emerging areas[reference:20].
- Serves as both a foundational textbook and an advanced reference for researchers and practitioners.
About the Editors
Susan Halabi, PhD, is a Professor of Biostatistics and Bioinformatics at Duke University School of Medicine. She has extensive experience in the design and analysis of cancer clinical trials and has served on numerous Data and Safety Monitoring Boards. Her research focuses on the development and validation of prognostic and predictive models, as well as innovative trial designs.
Stefan Michiels, PhD, is the Head of the Biostatistics and Epidemiology Department at Gustave Roussy, a comprehensive cancer center in France. He is also a Professor of Biostatistics at the University of Paris-Saclay. His research interests include the statistical methodology for clinical trials, particularly in the areas of biomarker evaluation, surrogate endpoints, and high-dimensional data analysis.
Related Books
- Clinical Trials in Oncology by Stephanie Green, John Crowley, and Jacqueline Benedetti
- Design and Analysis of Clinical Trials: Concepts and Methodologies by Shein-Chung Chow and Jun Shao
- Statistical Methods for Survival Data Analysis by Elisa T. Lee and John Wenyu Wang
- Biostatistical Design and Analysis in Oncology by Karl E. Peace and Ding-Geng Chen
- Adaptive Design Methods in Clinical Trials by Shein-Chung Chow and Mark Chang
- Clinical Trial Methodology by Karl E. Peace
- Oncology Clinical Trials: Successful Design, Conduct, and Analysis by Wm Kevin Kelly and Susan Halabi
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Frequently Asked Questions
Q: What can I learn by reading this book?
A: You will gain a comprehensive understanding of the statistical design, conduct, and analysis of oncology clinical trials, covering everything from early-phase dose-finding studies to late-phase confirmatory trials and advanced topics in precision medicine and statistical methodology.
Q: Is this book suitable for beginners?
A: While it provides foundational material, the book is best suited for statisticians and investigators with some background in biostatistics who are looking to deepen their expertise in oncology trials. It is also an excellent resource for graduate students in biostatistics or related fields.
Q: Is this book recommended for professionals?
A: Absolutely. It is an essential reference for biostatisticians, clinical researchers, and investigators working in oncology drug development, whether in academia, the pharmaceutical industry, or regulatory agencies.
Q: What topics are covered in this book?
A: The book covers a wide range of topics, including Phase I/II/III trial designs, adaptive designs, immunotherapy trials, biomarker-driven trials, rare disease trials, survival analysis, competing risks, cure models, surrogate endpoints, and methods for handling missing data, among many others.
Q: Why is this book useful for students and researchers?
A: It provides a unique combination of theoretical foundations and practical guidance, with case studies, real-world examples, and access to statistical code. The contributions from leading experts ensure that the content is both current and authoritative.
Q: Does the book cover precision medicine?
A: Yes, a dedicated section on personalized medicine covers biomarker-driven trials, genomic biomarker designs, and statistical methods for biomarker and subgroup evaluation.
Q: Is this book part of a series?
A: Yes, it is part of the Chapman & Hall/CRC Biostatistics Series, which includes numerous other high-quality texts in biostatistics.
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