文档介绍：Data Monitoring in Clinical Trials
David L. DeMets
Curt D. Furberg
Lawrence M. Friedman
Editors
Data Monitoring
in Clinical Trials
A Case Studies Approach
With 40 Illustrations
David L. DeMets Curt D. Furberg
Department of Biostatistics and Medical Department of Public Health Sciences
Informatics Wake Forest University School
University of Wisconsin Medical School of Medicine
Madison, WI 53972-4675 Winston-Salem, NC 27157
USA USA
Lawrence M. Friedman
Bethesda, MD
USA
Library of Congress Control Number:
ISBN-10: 0-387-20330-3 Printed on acid-free paper.
ISBN-13: 978-0387-20330-0
© 2006 Springer Science+Business Media, Inc.
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Preface
Monitoring of clinical trials for early evidence of benefit and harm has
gotten considerable More formal guidelines and requirements2–4
have evolved in recent years, but in fact monitoring of trials is a practice that
has been going on for almost four For trials that involved conditions
or interventions with serious risks, such as mortality or major morbidity, the
tradition and policy has been to have an independent mittee
to review accumulating data for evidence of harm or convincing benefit that
woul