Clinical Trials in Oncology

Introduction
A Brief History of Clinical Trials
The Southwest Oncology Group
Example Trials
The Reason for This Book
Statistical Concepts
Introduction
The Phase II Trial - Estimation
The Phase III Trial - Hypthesis Testing
The Proportional Hazards Model
Sample Size Calculations
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 Analyses
Data Monitoring Committees: Rationale and Responsibilities
Monitoring Committees: Composition
Examples
Concluding Remarks
Data Management and Quality Control
Introduction: Why Worry?
Protocol Development
Basic Data Items
Data Forms
Protocol Management and Evaluation
Quality Assurance Audits
Training
Database Management
Conclusion
Appendix: Examples
Reporting of Results
Timing of Report
Required Information
Analyses
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
Meta-Analysis
Concluding Remarks
Summary and Conclusions.