Clinical Trials in Oncology / Edition 1

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Overview

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 book deals with all aspects of successful trials in a manner accessible to clinicians. Topics addressed include advantages and disadvantages of multi-arm trials; pitfalls to avoid, such as analyzing survival by response or by dose; and how and whether meta-analyses are justified.

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.

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Editorial Reviews

From The Critics
Presenting advice on the methods and issues of proper clinical trial design and interpretation, the authors (affiliated with the Fred Hutchinson Cancer Research Center, U. of Washington, and the Statistical Center of the Southwest Oncology Group) proceed in a step- by-step fashion to describe trial methods they believe are unimpeachable. Chapters discuss statistical concepts, the design of clinical trials, multi-arm trials, interim analysis and data monitoring committees, data management and quality control, reporting of results, pitfalls, and exploratory analyses. Annotation c. Book News, Inc., Portland, OR
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Product Details

Table of Contents

Acknowledgments
1 Introduction 1
2 Statistical Concepts 11
3 The Design of Clinical Trials 41
4 Multi-Arm Trials 79
5 Interim Analysis and Data Monitoring Committees 97
6 Data Management and Quality Control 123
7 Reporting of Results 165
8 Pitfalls 181
9 Exploratory Analyses 209
10 Summary and Conclusions 233
Bibliography 237
Index 253
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  • Anonymous

    Posted December 14, 1999

    Health: Separating Sense from Sensationalism

    This little book is a sleeper. Despite its title, which gives the impression it might put you to sleep, it's a book you should read if you have any interest at all in alternative medicine, medical research, containment of health care costs, or your own personal health. Recommend it to friends who frequent 'health' food shops, who visit naturopaths, homeopaths, or chiropractors, who undertake fad diets, who are considering undergoing costly therapies not covered by health insurance. Its message is sobering, but vital. Let me start by admitting that I was privileged to review this work in manuscript. I liked it then; I like it even better in print. Its authors intended that it be read by a circumscribed elite, medical researchers investigating therapies for cancer. It ought to be read, in my opinion, by anyone with an open mind and an interest in questions such as: how can we tell what works (and what's safe) and what doesn't (or isn't)? Why won't my insurance cover bone marrow transplants (to pick one regimen from many)? If offered the opportunity to be a subject of a clinical trial (medical research), ought I to accept? Confronted with the abundance of sometimes conflicting medical advice now available on the Web, how do I know what to believe? The authors begin by invoking an aphorism, variously attributed, that enjoyed considerable currency a century ago: 'it ain't the things we don't know that cause trouble, it's the things we know that ain't so.' (The origin of this saying may be ancient indeed; first lady Eve was clearly assuming readers' familiarity with it when she wrote-referring to Adam, of course- that 'he is self-educated, and does really know a multitude of things, but they are not so.') The question, then, is how to avoid the pitfall of knowing things that aren't so. In medicine, the answer, the only good answer, is: clinical trials. Not anecdotes, not retrospective investigations of what thousands of people say they ate (or did or thought or felt) twenty years ago, not accretions of experience by licensed doctors, but well-designed, well-executed clinical trials. As this book shows, despite a few antecedents dating back to the time of Nebuchadnezzar, medical experiments on people are for the most part an innovation of the last half century. It used to be thought-it may still be thought by some-that experimenting on people is unethical. In truth, as this book makes eloquently clear, it may be unethical to treat people with therapies that have not been experimentally proven. Once again, Eve said it best (in words divinely revealed to that noted American theologian, Mark Twain): 'It is best to prove things by actual experiment; then you know; whereas if you depend on guessing and supposing and conjecturing, you will never get educated.' Before clinical trials, we had leeches, bloodletting, and arsenic, and, within the memory of people still living, routine needless childhood tonsillectomies. We also missed, for a decade or so, the very real benefits of streptomycin and penicillin, allowing countless people to die prematurely of what have proven to be easily treatable diseases. This book is a bit technical. It is customary, for reasons that elude me, to apologize for the presence of even the most elementary mathematics in a book. Yes, there is a mathematical chapter in 'Clinical Trials'. The mathematics is by no means advanced, and is well elucidated. A reader who elects to skip this chapter will still glean valuable insights about medical research and care, but the reader who enters it bravely will emerge at the far end with a more than adequate understanding of the answers to questions too often glossed over in popular articles on medicine: What does it mean, for example, to say that a new treatment is superior to the old by sixty percent?

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