E-Book Overview
This book compiles state-of-the-art statistical approaches to solving problems in clinical oncology, focusing on clinical trials in phases I, II, and III, as well as quality of life and economic analyses, and exploratory methods. Examines trial design treatment based on toxicity and survival! Featuring over 1000 references, more than 40 world-renowned contributors, and 300 equations, tables, and drawings, the Handbook of Statistics in Clinical Oncology provides a comprehensive discussion of sample size considers analytical problems generated by controlling treatment costs and maintaining quality of life demonstrates the breadth and depth of current activity in the field of survival analysis sets the limits on what can and cannot be concluded from single and multiple clinical trials and more! The best single source for up-to-date graphical, tree-based, and other statistical methods, the Handbook of Statistics in Clinical Oncology is fascinating reading for oncologists, cancer researchers, biostatisticians, applied statisticians, and medical and graduate students in these disciplines.
E-Book Content
ISBN: 0-8247-9025-1 This book is printed on acid-free paper. Headquarters Marcel Dekker, Inc. 270 Madison Avenue, New York, NY 10016 tel: 212-696-9000; fax: 212-685-4540 Eastern Hemisphere Distribution Marcel Dekker AG Hutgasse 4, Postfach 812, CH-4001 Basel, Switzerland tel: 41-61-261-8482; fax: 41-61-261-8896 World Wide Web http:/ /www.dekker.com The publisher offers discounts on this book when ordered in bulk quantities. For more information, write to Special Sales/Professional Marketing at the headquarters address above. Copyright 2001 by Marcel Dekker, Inc. All Rights Reserved. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Current printing (last digit): 10 9 8 7 6 5 4 3 2 1 PRINTED IN THE UNITED STATES OF AMERICA
To my mother, who has been an inspiration to me for 55 years, and to others for 91.
The idea for this book came to me from Graham Garrett of Marcel Dekker, Inc., who, tragically, passed away while the book was in progress. I hope that the result lives up to his expectations. All royalties for the editor will go to Cancer Research And Biostatistics, a nonprofit corporation whose mission is to help conquer cancer through the application of biostatistical principles and data management methods.
Preface
This book is a compendium of statistical approaches to the problems facing those trying to make progress against cancer. As such, the focus is on cancer clinical trials, although several of the contributions also apply to observational studies, and many of the chapters generalize beyond cancer research. This field is approximately 50 years old, and it has been at least 15 years since such a summary appeared; because much progress has been made in recent decades, the time is propitious for this book. The intended audience is primarily but not exclusively statisticians working in cancer research; it is hoped that oncologists might benefit as well from reading this book. The book has six sections: 1. Phase I Trials. This area has moved from art to science in the last decade, thanks largely to the contributors to this book. 2. Phase 2 Trials. Recent advances beyond the widely accepted two-stage design based on tumor response include designs based on toxicity and response and selection designs, meant to guide in the decisions regarding which of many treatments to move to Phase 3 trials. 3. Phase 3 Trials. A comprehensive treatment is provided of sample size, as well as discussions of multiarm trials, equivalence trials, and early stopping. 4. Complementary Outcomes. Qualit