Clinical Trials in Oncology, Second Edition
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Summary
Studies that are unimpeachably thorough, non-political, unbiased, and properly designed… These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present.
The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background.
Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.
Table of Contents
INTRODUCTION
A Brief History of Clinical Trials
The Southwest Oncology Group
Example Trials
The Reason for the Book
STATISTICAL CONCEPTS
Introduction
The Phase II Trial-Estimation
The Phase III Trial-Hypothesis Testing
The Proportional Hazards Model
Sample Size Calculations
Concluding Remarks
THE DESIGN OF CLINICAL TRIALS
Introduction
Endpoints
Phase I Trials
Phase II Trials
Phase III Trials
Conclusion
MULTI-ARM TRIALS
Introduction
Types of Multi-Arm Trials
Significance Level
Power
Interaction
Other Model Assumptions
To Screen or Not to Screen
Timing of Randomization
Conclusion
INTERIM ANALYSIS AND DATA MONITORING COMMITTEES
Planned Interim Analysis
Data Monitoring Committees: Rationale and Responsibilities
Monitoring Committees: Composition
Examples
Concluding Remarks
DATA MANAGEMENT AND QUALITY CONTROL
Introduction: Why Worry?
Protocol Development
Data Collection
Protocol Management and Evaluation
Quality Assurance Audits
Training
Data Base Management
Conclusion
Appendix: Examples
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
Editorial 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
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