Clinical Trials in Oncology, Third Edition

3. Auflage 2012
ISBN: 978-1-4398-1448-2
Verlag: CRC Press

Buch, Englisch, Band 28, 264 Seiten, Format (B × H): 161 mm x 240 mm, Gewicht: 567 g

Reihe: Chapman & Hall/CRC Interdisciplinary Statistics

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.

Zielgruppe

Clinical oncologists and trial managers, biostatisticians, and graduate students of biostatistics

Autoren/Hrsg.

Smith, Angela

Green, Stephanie

Crowley, John

Benedetti, Jacqueline

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Klinische und Innere Medizin Onkologie, Krebsforschung

Inhaltsverzeichnis

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