Robert Finn - Cancer clinical trials: experimental treatments & how they can help you
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Cancer Clinical Trials: Experimental Treatments & How They Can Help You by Robert Finn
Copyright (c) 1999 Robert Finn. All rights reserved. Printed in the United States of America.
Published by O'Reilly & Associates, Inc., 101 Morris Street, Sebastopol, CA 95472.
Editor: Linda Lamb Production Editor: Sarah Jane Shangraw Production Services: Alicia Cech
Printing History:
September 1999: First Edition
The O'Reilly logo is a registered trademark of O'Reilly & Associates, Inc. Many of the designations used by manufacturers and sellers to distinguish their products are claimed as trademarks. Where those designations appear in this book, and O'Reilly & Associates, Inc. was aware of a trademark claim, the designations have been printed in caps or initial caps.
This book is meant to educate and should not be used as an alternative for professional care. Although we have exerted every effort to ensure that the information presented is accurate at the time of publication, there is no guarantee that this information will remain current over time. Appropriate medical professionals should be consulted before adopting any procedures or treatments discussed in this book.
Library of Congress Cataloging-in-Publication Data Finn, Robert. 1955 Cancer clinical trials: experimental treatments & how they can help you / Robert Finn p. cm.-(Patient-centered guides) Includes bibliographical references and index. ISBN 1-56592-566-1 (pbk.) 1. Cancer-Research. 2. Cancer-Popular works. 3. Antineoplastic agents-Testing. 4. Clinical trials. I. Title. II. Series. RC267.F56 1999 616.99'406-dc21 99-38927 CIP
This book is printed on acid-free paper with 85% recycled content, 15% post consumer waste. O'Reilly & Associates, Inc. is committed to using paper with the highest recycled content available consistent with high quality.
Page v
Dedicated to everyone who has ever participated in a cancer clinical trial. You are all heroes.
Page vii
Table of Contents
Foreword
ix
Preface
xiii
1. Overview of Clinical Trials
1
2. The Structure of Clinical Trials
13
3. Clinical Trial Ethics
35
4. How to Find Clinical Trials
57
5. Special Types of Trials
81
6. Choosing Possible Trials
91
7. Evaluating a Clinical Trial
101
8. Administration of Clinical Trials
127
9. Financial Issues
141
A. Resources
169
B. Critical Public Documents
169
Notes
189
Index
195
Page ix
Foreword
It is a figure cited routinely nowadays at meetings of cancer advocates, physicians, and drug company executives. Only 3 percent of adult cancer patients in the United States take part in clinical trials, even though every one of those groups professes to want the number to be much higher. In the face of cancer survival statistics far below what anyone would want, why do we have such minimal enrollment in clinical trials? How will we ever know what works, goes the argument, if we are not trying new treatments?
In fact, powerful forces in American medicine often impede the progress of clinical trials and increase the difficulty at every step. Few realize that the entire concept of basing medicine on the scientific rigor of clinical trials is a recent phenomenonbeginning after the Second World War. Until then the backbone of clinical practice was that the physician knows what is best for the patientno matter how he or she happened to gain that knowledge. Entering a patient into a clinical trial is first and foremost the admission by a physician of at least partial ignorance and a willingness to try to overcome it.
More recently, negative financial considerations helped provoke many physicians' reluctance. This is especially so in the specialty of cancer treatment, or oncology. As the practice of oncology grew and specialists moved out of academic medical centers into the community, doctors willing to suggest clinical trials for their
Page x
patients often lost income and control of the patient's care. To try to overcome this difficulty, drug companies and their intermediaries, contract research organizations, often paid community doctors to enroll patients. The payments cover the additional time and effort required to collect massive amounts of information from each experimental patient, as opposed to standard records for routine treatment. Occasionally, however, the payments exceed the actual costs and include inducements to enroll trial participants. Some doctors even receive invitations to meetings in sunny resorts with expenses paid for them and a companion. These additional payments have led to inevitable allegations that they lead to biased results.
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