Chapman and Hall/CRC Interdisciplinary Statistics, Volume 28 : Clinical Trials in Oncology, Third Edition

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 overc. Read more... Abstract: 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 overc The third edition 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 This book 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. This book 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. The new edition of the bestselling 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 pitfalls inherent in these processes. This edition includes a new section covering innovations in Phase I designs and another on overcoming the challenges of array data. 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. Front Cover 1 Contents 8 1. Introduction 14 2. Statistical Concepts 20 3. The Design of Clinical Trials 48 4. Phase I and Phase I/II Trials 70 5. Phase II Trials 86 6. Phase III Trials 100 7. Data Management and Quality Control 142 8. Reporting of Results 168 9. Pitfalls 182 10. Exploratory Analyses 210 11. Summary and Conclusions 232 References 236 Back Cover 255 Clinical Trials in Oncology emphasizes the importance of proper study design and data management, and explains why communication and partnership between statisticians and clinicians are vital to the conduct of a successful clinical trial. Clinicians face considerable risks-subtle and ever present-when designing trials and interpreting data. This bo Content: Front Cover Contents 1. Introduction 2. Statistical Concepts 3. The Design of Clinical Trials 4. Phase I and Phase I/II Trials 5. Phase II Trials 6. Phase III Trials 7. Data Management and Quality Control 8. Reporting of Results 9. Pitfalls 10. Exploratory Analyses 11. Summary and Conclusions References Back Cover.