Clinical Trials in Oncology

Description

The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data.

Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

Features

• Includes new sections on Phase I design and array data
• Emphasizes the importance of proper design, management, and analysis
• Incorporates expanded discussions on competing risks, subset analyses, and randomized Phase IIs
• Contains further comments on prognostic factor analysis
• Clearly describes complex exploratory analysis methods

Reviews

"The dedication of the authors to enhancing the quality of clinical trials in oncology is evident from this book. … This book will be useful to students, clinical research nurses and medical statisticians involved in oncology trials. … I also recommend it to libraries and clinical institutions."
—Clinical Trials, 2004

"With over 60 years combined experience, the authors are ideally positioned to discuss the various statistical issues apparent in clinical trials, identifying alternative solutions, providing logical arguments for and against the various solutions. This book is also recommended for statisticians actively involved in the design, conduct, and analysis of clinical trial data (not only cancer clinical trials)."
—Journal of Biopharmaceutical Statistics

"A concise, easily readable, and thorough summary…ALL medical oncology, radiation oncology, surgical oncology, and clinical research nurse academic training programs should provide this important text to trainees on Day 1."
—Charles R. Thomas Jr., MD, University of Texas Health Science Center at San Antonio, USA

"Succinct and focused…[This book] is clear, cogent, and practical. It is structured so that statisticians can use specific sections as starting point to develop shared understandings with investigators, study coordinators, and data managers…It has been useful to me and my clients, and I look forward to the second edition."
—Marlene Egger, University of Utah, USA

Table of Contents

• Introduction
• A Brief History of Clinical Trials
• The Southwest Oncology Group (SWOG)
• The Reason for This Book
• Statistical Concepts
• Introduction
• The Single-Arm Phase II Trial—Estimation
• The Randomized Phase III Trial—Hypothesis Testing
• The Proportional Hazards Model
• Sample Size Calculations
• Concluding Remarks
• The Design of Clinical Trials
• Objectives
• Eligibility
• Treatment Arms
• Randomized Treatment Assignment
• Endpoints
• Differences to be Detected or Precision of Estimates and Other Assumptions
• Use of Independent Data Monitoring Committees
• Ethical Considerations
• Conclusion
• Phase I and Phase I/II Trials
• Phase I Trials
• Phase I/II Designs
• Phase II Trials
• Single-Arm Phase II Designs
• Multi-Arm Phase II Trials
• Other Phase II Designs
• Randomized versus Single-Arm: The Pros and Cons
• Conclusion
• Phase III Trials
• Randomization
• Other Design Considerations
• Equivalence or Noninferiority Trials
• Designs for Targeted Agents
• Multi-Arm Trials
• Interim Analyses
• Phase II/III Trials
• Concluding Remark
• Data Management and Quality Control
• Introduction: Why Worry?
• Protocol Development
• Data Collection
• Data Submission
• Data Evaluation
• Publication
• Quality Assurance Audits
• Training
• Database Management
• Conclusion
• Reporting of Results
• Timing of Report
• Required Information
• Analyses
• Conclusion
• Pitfalls
• Introduction
• Historical Controls
• Competing Risks
• Outcome by Outcome Analyses
• Subset Analyses
• Surrogate Endpoints
• Exploratory Analyses
• Introduction
• Some Background and Notation
• Identification of Prognostic Factors
• Forming Prognostic Groups
• Analysis of Microarray Data
• Meta-Analysis
• Concluding Remarks
• Summary and Conclusions
• References
• Index