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Clinical Trials in Oncology, Second Edition

By Stephanie Green, John Crowley, Jacqueline Benedetti, Angela Smith

Chapman and Hall/CRC – 2002 – 280 pages

Series: Chapman & Hall/CRC Interdisciplinary Statistics

Purchasing Options:

  • Hardback:
    978-1-58488-302-9
    July 30th 2002
    Out-of-print

Description

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.

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

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

Name: Clinical Trials in Oncology, Second Edition (eBook)Chapman and Hall/CRC 
Description: By Stephanie Green, John Crowley, Jacqueline Benedetti, Angela Smith. 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...
Categories: Oncology, Medical Statistics & Computing