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.