Methods and Applications of Statistics in Clinical Trials, Volume 1
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Reviews / Votes
"Methods and Applications of Statistics in Clinical Trials is a comprehensive, in-depth and up-to-date guide to statistics in clinical research. Most readers will have more than an introductory understanding of statistics." (Journal of Clinical Research Best Practices, 5 May 2015) "This book provides an excellent description of the methods and applications of statistics to design clinical trials and to understand and evaluate data at different stages of clinical trials. It is strongly recommended for researchers, practitioners, and students." (Doody's, 13 February 2015)More details
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Content
Contributors xxiii
Preface xxix
1 Absolute Risk Reduction 1
2 Accelerated Approval 14
3 AIDS Clinical Trials Group (ACTG) 27
4 Algorithm-Based Designs 40
5 Alpha-Spending Function 53
6 Application of New Designs in Phase I Trials 65
7 ASCOT Trial 74
8 Benefit/Risk Assessment in Prevention Trials 80
9 Biased Coin Randomization 90
10 Biological Assay, Overview 106
11 Block Randomization 125
12 Censored Data 139
13 Clinical Data Coordination 146
14 Clinical Data Management 164
15 Clinical Significance 170
16 Clinical Trial Misconduct 191
17 Clinical Trials, Early Cancer and Heart Disease 205
18 Cluster Randomization 216
19 Coherence in Phase I Clinical Trials 230
20 Compliance and Survival Analysis 240
21 Composite Endpoints in Clinical Trials 246
22 Confounding 252
23 Control Groups 263
24 Coronary Drug Project 273
25 Covariates 285
26 Crossover Design 300
27 Crossover Trials 310
28 Diagnostic Studies 320
29 DNA Bank 340
30 Up-and-Down and Escalation Designs 353
31 Dose Ranging Crossover Designs 362
32 Flexible Designs 383
33 Gene Therapy 399
34 Global Assessment Variables 423
35 Good Clinical Practice (GCP) 438
36 Group-Randomized Trials 448
37 Group Sequential Designs 467
38 Hazard Ratio 483
39 Large Simple Trials 500
40 Longitudinal Data 510
41 Maximum Duration and Information Trials 515
42 Missing Data 522
43 Mother to Child Human Immunodeficiency Virus Transmission Trials 536
44 Multiple Testing in Clinical Trials 550
45 Multicenter Trials 558
46 Multiple Endpoints 570
47 Multiple Risk Factor Intervention Trial 577
48 N-of-1 Randomized Trials 587
49 Noninferiority Trial 598
50 Nonrandomized Trials 609
51 Open-Labeled Trials 619
52 Optimizing Schedule of Administration in Phase I Clinical Trials 625
53 Partially Balanced Designs 635
54 Phase I/II Clinical Trials 658
55 Phase II/III Trials 667
56 Phase I Trials 682
57 Phase II Trials 692
58 Phase III Trials 700
59 Phase IV Trials 711
60 Phase I Trials in Oncology 719
61 Placebos 725
62 Planning a Group-Randomized Trial 736
63 Postmenopausal Estrogen/Progestin Interventions Trial (PEPI) 744
64 Preference Trials 759
65 Prevention Trials 770
66 Primary Efficacy Endpoint 779
67 Prognostic Variables in Clinical Trials 789
68 Randomization Procedures 799
69 Randomization Schedule 813
70 Repeated Measurements 827
71 Simple Randomization 841
72 Subgroups 850
73 Superiority Trials 867
74 Surrogate Endpoints 878
75 TNT Trial 887
76 UGDP Trial 894
77 Women's Health Initiative Hormone Therapy Trials 918
78 Women's Health Initiative Dietary Modification Trial 931
Index 945
Contributors
Ian E. Alexander, Gene Therapy Research Unit of the Children’s Medical Research Institute and The Children’s Hospital at Westmead and University of Sydney, Discipline of Paediatrics and Child Health, Westmead, Australia, ian.alexander@health.nsw.gov.au
Janet W. Andersen, Harvard School of Public Health, Boston, MA, andersen@hsph.harvard.edu
Per Kragh Andersen, University of Copenhagen, Copenhagen, Denmark, pka@biostat.ku.dk
Andrew L. Avins, University of California, San Francisco, CA
Rosemary A. Bailey
Peter Bauer, *Deceased, 2002
David B. Barr, Kendle International, Cincinnati, OH
Shari S. Bassuk, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, sbassuk@rics.bwh.harvard.edu
Jeannette M. Beasley, Albert Einstein College of Medicine, Bronx, NY, jeannette.beasley@einstein.yu.edu
Vance W. Berger, National Cancer Institute, Bethesda, MD¡ bergerv@mail.nih.gov
Werner Brannath, University of Bremen, Bremen, Germany, brannath@math.uni-bremen.de
Michael Branson, Norvatis Pharma AG, Basel, Switzerland, michael.branson@novartis.com
Thomas Braun, University of Michigan Arm Arbor, MI, tombraun@umich.edu
Frank Bretz, Norvatis Pharma AG, Basel, Switzerland, frank.bretz@novartis.com
Louis Cabanilla, Tufts University Center for the Study of Drug Development Boston, MA
Marion K. Campbell, University of Aberdeen, Aberdeen, UK, m.k.campbell@abdn.ac.uk
Paul L. Canner, Maryland Medical Research Institute, Baltimore, MD, plcanner@juno.com.
Joseph C. Cappelleri, Pfizer, Inc., Global Research & Development, Groton, CT, Joseph.c.cappelleri@pfizer.com
Rick Chappell, University of Wisconsin, Madison, WI, chappell@biostat.wise.edu
Ying-Kuen K. Cheung, Columbia University, New York, NY, cheung@biostat.columbia.edu
Sylvie Chevret, Inserm, Paris, France, sylvie.chevret@univ-paris-diderot.fr
Joseph P. Costantino, University of Pittsburgh, Pittsburgh, PA, costan@nsabp.pitt.edu
Simon Day, Roche Products Ltd., Welwyn Garden City, UK, simon.day@Roche.com
Victor DeGruttola, Harvard School of Public Health, Boston, MA, victor@sdac.harvard.edu
David L. DeMets, University of Wisconsin-Madison, Madison, WI, demets@biostat.wise.edu
Chongzhi Di, Fred Hutchinson Cancer Research Center, Seattle, WA, cdi@fhcrc.org
Alexei Dmitrienko, Eli Lilly and Company Indianapolis, Indianapolis, IN
Allan Donner, University of Western Ontario, London, ON, Canada, allan.donner@schulich.uwo.ca
Therese Dupin-Spriet
Peter J. Dyck, Mayo Clinic College of Medicine, Rochester, MN, dyck.peter@mayo.edu
Lynn E. Eberly, University of Minnesota, Minneapolis, MN, lynn@biostat.umn.edu
Thomas R. Fleming, University of Washington, Seattle, DC, tfleming@u.washington.edu
Dean A. Follmann, National Institute of Allergy and Infectious Diseases, Bethesda, MD, dfollmann@niaid.nih.gov
Mary A. Foulkes, The George Washington University, Washington, DC, mfoulkes@bsc.gwu.edu
Elizabeth Garrett-Mayer, Johns Hopkins University, Baltimore, MD, garrettm@musc.edu
Edmund A. Gehan, Georgetown University Medical Center, Washington, DC, gehane@georgetown.edu
Samantha L. Ginn, Gene Therapy Research Unit of the Children’s Medical Research Institute and The Children’s Hospital at Westmead and The University of Sydney, Sydney Medical School, Syndey, Australia, sginn@cmri.org.au
Els Goetghebeur, Ghent University, Ghent, Belgium, Els.Goetghebeur@UGent.be
Charles H. Goldsmith
Erika Graf, Clinical Trials Unit, University Medical Center Freiburg, Freiburg, Germany, egr@imbi.uni-freiburg.de
William C. Grant
Stephanie Green, Clinical Biostatistics, Pfizer, Inc., New London, CT
Sander Greenland, University of California, Los Angeles, CA, lesdomes@ucla.edu
Scott M. Grundy, University of Texas Southwestern Medical Center, Dallas, TX, scott.grundy@utsouthwestern.edu
Weili He, Merck & Co., Inc., Rahway, NJ, weili_he@merck.com
Anne Holbrook, McMaster University, Hamilton, ON, Canada, holbrook@mcmaster.ca
Jason C. Hsu, Ohio State University, Columbus, OH, Hsu.1@osu.edu
Peng Huang, John Hopkins University, Baltimore, MD, phuang12@jhmi.edu
Ying Huang, Fred Hutchinson Cancer Research Center, Seattle, WA, yhuang@fhcrc.org
H. M. James Hung, U.S. Food and Drug Administration Silver Spring, MD, hsienming.hung@fda.hhs.gov
Anastasia Ivanova, University of North Carolina at Chapel Hill, NC, aivanova@bios.unc.edu
Sudha K. Iyengar, Case Western Reserve University, Cleveland, OH, ski@case.edu
Byron Jones, Pfizer Pharmaceuticals, Sandwich, UK
Celia C. Kamath, Health Sciences Research, Mayo Clinic, Rochester, MN, kamath.celia@mayo.edu
Oliver Keene, GlaxoSmithKline Research and Development, Stockley Park, UK, oliver.n.keene@gsk.com
Michael G. Kenward, London School of Hygiene and Tropical Medicine, London, UK, Mike.Kenward@lshtm.ac.uk
Kyungmann Kim, University of Wisconsin, Madison, WI, kmkim@biostat.wisc.edu
Cheryl Kious, Quintiles Transnational Corporation, Durham, NC
Neil Klar, Cancer Care Ontario, Toronto, ON, Canada, neil.klar@schulich.uwo.ca
Lewis H. Kuller, University of Pittsburgh, Pittsburgh, PA, kullerl@edc.pitt.edu
Olga M. Kuznetsova, Merck & Co., Inc. Rahway, NJ, olga_kuznetsova@merck.com
K. K. Gordon Lan, Johnson & Johnson, Raritan, NJ, Glan@prdus.jnj.com
Robert D. Langer, University of Nevada School of Medicine, Las Vegas, NV, rdlanger@jhcpm.com
John C. Larosa, State University of New York Health, Science Center, Brooklyn, NY
Emmanuel Lesaffre, Catholic University of Leuven, Leuven, Belgium, emmanuel.lesaffre@med.kuleuven.be
Mova Leung, Carlo Fidani Peel Regional Cancer Centre, Credit Valley Hospital, Mississauga, ON, Canada
Hung-I Li
Wenjun Li, University of Massachusetts Medical School, Worcester, MA, Wenjun.Li@umassmed.edu
Zhengqing Li, Global Biometric Science, Bristol-Myers Squibb Company, Wallingford, CT
Jun Liu, Columbia University, New York, NY, liuj@childpsych.columbia.edu
Qing Liu, Johnson and Johnson Pharmaceutical, Research and Development, Raritan, NJ, QLiu2@its.jnj.com
Craig Mallinckrodt, Eli Lilly and Company, Indianapolis, IN, mallinckrodt_craig@lilly.com
JoAnn E. Manson, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, jmanson@rics.bwh.harvard.edu
Ruth McBride, Axio Research, Seattle, WA, davidk@axioresearch.com
Damian McEntegart, ClinPhone Group Ltd., Nottingham, UK, dmcenteg@clinphone.com
Jesper Mehlsen, Frederiksberg Hospital—Clinical, Physiology & Nuclear Medicine, Frederiksberg, Denmark, jesper.mehlsen@frh.regionh.dk
Curtis L. Meinert, The Johns Hopkins...
