Biostatistics in Clinical Trials

Front Cover
Carol K. Redmond, Theodore Colton
John Wiley & Sons, Apr 25, 2001 - Medical - 522 pages
The second volume in the Wiley reference series in Biostatistics.
Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in:
  • Bayesian methods
  • Benefit/risk assessment
  • Cost-effectiveness
  • Ethics
  • Fraud

With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature.
Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials:

  • Includes concise definitions and introductions to numerous concepts found in current literature
  • Discusses the software and textbooks available
  • Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts

Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.

 

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Contents

Adaptive and Dynamic Methods
1
Audit and Quality Control
9
BenefitRisk Assessment
18
Blinding or Masking
25
Clinical Significance Versus Statistical
35
Cluster Randomization
51
Cochrane Collaboration
65
Compliance Assessment
76
Missing Data
283
Multiple Endpoints
292
Noncompliance Adjustment
303
NSABP and Advances in
310
Number Needed to Treat NNT
321
Pharmaceutical Industry Statistics
331
Trials
337
Physicians Health Study
348

Cooperative Studies Program
99
Costeffectiveness
115
Covariate Imbalance Adjustment
122
Data and Safety Monitoring
145
Data and Safety Monitoring Boards
154
Drug Approval and Regulation
160
Drug Interactions
172
Equivalence Trials
179
European Federation of Statisticians
189
Grouprandomization Designs
209
Historical Controls Bias From
225
History Overview
235
IntentiontoTreat Analysis
245
Medical Ethics and Statistics
257
Medical Research Council MRC
271
Preclinical Treatment Evaluation
361
Prevention Trials
367
QUOROM
379
Salk Vaccine
393
Screening Trials
406
Sequential Methods
414
Society for Clinical Trials
422
Textbooks
451
Timevarying Treatment Effect
460
University Group Diabetes Program
469
Vaccine Studies
479
225
495
443
500
Copyright

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About the author (2001)

CAROL K. REDMOND, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Carol Redmond earned an M.S. and Sc.D. in Biostatistics from the University of Pittsburgh. She has been a faculty member at the University of Pittsburgh Graduate School of Public Health since 1967 and served as Professor and Chairperson of the Department of Biostatistics from 1983 through 1996. She is presently Distinguished Service Professor and Vice Dean for Academic Affairs at the Graduate School of Public Health. From 1978 to 1994 she was the Founding Director of the Biostatistical Center for the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative clinical trial group that has conducted landmark randomized multicenter clinical trials for treatment and prevention of breast cancer. She has authored or co-authored more than 160 articles in biostatistical or biomedical publications. She is a previous member of the Editorial Boards for Statistics in Medicine and the Journal of Clinical Oncology. Dr. Redmond has been the recipient of a number of awards and honors including election as a Fellow of the American Statistical Association and the American College of Epidemiology. She has served as elected chair of the Statistics Section of the American Public Health Association and is currently President-Elect of the Biometric Society (Eastern North American Region) and a member of the Executive Committee of the International Society for Clinical Biostatistics. She has also participated in numerous peer review groups, advisory panels, and data monitoring committees for government and private agencies, including several of the National Institutes of Health, the Department of Veterans Affairs, and the Centers for Disease Control.

THEODORE COLTON, Boston University, Boston, Massachusetts, USA
Theodore Colton earned an M.S. in Statistics from the University of North Carolina and an Sc.D. in Biostatistics from Johns Hopkins School of Hygiene and Public Health. He has held faculty positions at Harvard Medical School, Dartmouth Medical School, and Boston University School of Public Health where he is currently Professor and Chair of the Department of Epidemiology and Biostatistics. He was twice the recipient of fellowship awards, from the National Science Foundation and the National Institutes of Health, for study at the London School of Hygiene and Tropical Medicine. He was one of the founding editors in 1981 of the Wiley Journal Statistics in Medicine and has served as editor through 1997, nurturing the growth of the journal from 381 pages in four issues in 1982 to 2972 pages in twenty-four issues in 1997. He is author of the textbook, Statistics in Medicine. Dr. Colton has served as a member of the Editorial Board of the New England Journal of Medicine and has been a biostatistical consultant to the editors of the Journal of the American Medical Association. He is a fellow of the American Statistical Association, the American College of Epidemiology, and the American Association for the Advancement of Science and he has served as president of Biometrics (Eastern North-American Region) and the Statistics Section of the American Public Health Association. He has served and continues to serve on numerous advisory committees and peer review groups for governmental agencies including the National Institutes of Health, the Centers for Disease Control, and the Department of Veterans Affairs.

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