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The Prevention and Treatment of Missing Data in Clinical Trials This PDF is available from The National Academies Press at http://www.nap.edu/catalog.php?record_id=12955 The Prevention and Treatment of Missing Data in Clinical Trials ISBN Panel on Handling Missing Data in Clinical Trials; National Research 978-0-309-15814-5 Council 162 pages 6 x 9 PAPERBACK (2010) Visit the National Academies Press online and register for... Instant access to free PDF downloads of titles from the NATIONAL ACADEMY OF SCIENCES NATIONAL ACADEMY OF ENGINEERING INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL 10% off print titles Custom notification of new releases in your field of interest Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Request reprint permission for this book Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials Panel on Handling Missing Data in Clinical Trials Committee on National Statistics Division of Behavioral and Social Sciences and Education Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by contract number HHSF223200810020I, TO #1 between the National Academy of Sciences and the U.S. Food and Drug Adminis- tration. Support for the work of the Committee on National Statistics is provided by a consortium of federal agencies through a grant from the National Science Foundation (award number SES-0453930). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-15814-5 International Standard Book Number-10: 0-309-15814-1 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Research Council. (2010). The Prevention and Treat- ment of Missing Data in Clinical Trials. Panel on Handling Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials PANEL ON HANDLING MISSING DATA IN CLINICAL TRIALS RodericK J.A. Little (Chair), Department of Biostatistics, University of Michigan, Ann Arbor Ralph D’Agostino, Department of Mathematics and Statistics, Boston University KaY DicKersin, Department of Epidemiology, Johns Hopkins University Scott S. Emerson, Department of Biostatistics, University of Washington, Seattle John T. Farrar, Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine Constantine FrangaKis, Department of Biostatistics, Johns Hopkins University Joseph W. Hogan, Center for Statistical Sciences, Program in Public Health, Brown University Geert Molenberghs, International Institute for Biostatistics and Statistical Bioinformatics, Universiteit Hasselt and Katholieke Universiteit Leuven, Belgium Susan A. MurphY, Department of Statistics, University of Michigan, Ann Arbor James D. Neaton, School of Public Health, University of Minnesota Andrea RotnitZKY, Departmento de Economia, Universidad Torcuato Di Tella, Buenos Aires, Argentina Daniel Scharfstein, Department of Biostatistics, Johns Hopkins University Weichung (Joe) Shih, Department of Biostatistics, University of Medicine and Dentistry of New Jersey School of Public Health JAY P. Siegel, Johnson & Johnson, Radnor, Pennsylvania Hal Stern, Department of Statistics, University of California, Irvine MICHAEL L. COHEN, Study Director AGNES GASKIN, Administrative Assistant v Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials COMMITTEE ON NATIONAL STATISTICS 2009-2010 WILLIAM F. EDDY (Chair), Department of Statistics, Carnegie Mellon University KATHARINE G. ABRAHAM, Department of Economics and Joint Program in Survey Methodology, University of Maryland ALICIA CARRIQUIRY, Department of Statistics, Iowa State University WILLIAM DuMOUCHEL, Phase Forward, Inc., Waltham, Massachusetts JOHN HALTIWANGER, Department of Economics, University of Maryland V. JOSEPH HOTZ, Department of Economics, Duke University KAREN KAFADAR, Department of Statistics, Indiana University SALLIE KELLER, George R. Brown School of Engineering, Rice University LISA LYNCH, Heller School for Social Policy and Management, Brandeis University DOUGLAS MASSEY, Department of Sociology, Princeton University SALLY C. MORTON, Biostatistics Department, University of Pittsburgh JOSEPH NEWHOUSE, Division of Health Policy Research and Education, Harvard University SAMUEL H. PRESTON, Population Studies Center, University of Pennsylvania HAL STERN, Department of Statistics, University of California, Irvine ROGER TOURANGEAU, Joint Program in Survey Methodology, University of Maryland, and Survey Research Center, University of Michigan ALAN ZASLAVSKY, Department of Health Care Policy, Harvard Medical School CONSTANCE F. CITRO, Director vi Copyright © National Academy of Sciences. All rights reserved. The Prevention and Treatment of Missing Data in Clinical Trials Acknowledgments I would like to express appreciation to the following individuals who provided valuable assistance in producing this report. Particular thanks to Robert O’Neill and Tom Permutt at the U.S. Food and Drug Administra- tion (FDA) for initiating the project, providing excellent presentations at the first meeting of the panel, and continuing support in providing timely information. We also thank Frances Gipson, FDA’s technical representa- tive, who assisted greatly in arranging the panel’s first meeting at FDA and acquiring FDA documents throughout the study. The following FDA staff members presented
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