Biostatistics in Clinical Trials

CAROL K. REDMOND, University of Pittsburgh, Pittsburgh, Pennsylvania, USACarol 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, USATheodore 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.

"Every professional statistician should have this well written and well composed book in his/her collection." (Journal of Statistical Computation and Simulation, September 2005) "...strongly recommended as a reference for an overview of biostatistics in clinical trials..." (Statistical Methods in Medical Research, Vol.12, No.4, 2003)"highly informative and useful book" (Journal of Tropical Paediatrics, February 2002)"This highly informative and readable book is part of the Wiley Reference Series in Biostatistics. This book will be a useful tool for generating the required evidence and is a handy reference for the design, conduct, analysis and interpretation of clinical trials." (Journal of Tropical Pediatricstrics)"...a valuable reference and an excellent resource to add to classroom and other teaching tools..." (Oncology, Vol.63, No.1, 2002)

• Adaptive and Dynamic Methods of Treatment Assignment. Antibacterial Agent Trials. Audit and Quality Control. Bayesian Methods. Benefit/Risk Assessment. Binding or Masking. Clinical Significance Versus Statistical Significance. Clinical Trials, Overview. Cluster Randomization. Cochrane Collaboration. Community Intervention Trials. Compliance Assessment. CONSORT. Controlled Clinical Trials. Cooperative Cancer Trials. Cooperative Heart Disease Trials. Cooperative Studies Program, US Department of Veterans Affairs. Cost-effectiveness. Covariate Imbalance, Adjustment for. Crossover Designs. Data and Safety Monitoring. Data and Safety Monitoring Boards. Data Management and Coordination. Drug Approval and Regulation. Drug Interactions. Eligibility and Exclusion Criteria. Equivalence Trials. Ethics. European Federation of Statisticians in the Pharmaceutical Industry (EFPSI). European Organization for Research and Treatment of Cancer (EORTC). Factorial Designs. Fraud. Group-randomization Designs. Guidelines. Historical Controls, Bias From. History, Early Cancer and Heart Disease Trials. History, Overview. Intention-to-Treat Analysis. International Studies of Infarct Survival (ISIS). Medical Ethics and Statistics. Medical Research Council (MRC) Streptomycin Trial. Meta-analysis. Missing Data. Multicenter Trials. Multiple Endpoints. Multiplicity. Noncompliance, Adjustment for. Nonrandomized Trials. NSABP and Advances in the Treatment of Breast Cancer. Number Needed to Treat (NNT). Outcome Measures. Pharmaceutical Industry, Statistics in. Phase I Trials. Phase II Trials. Physicians' Health Study. Postmarketing Surveillance of New Drugs and Assessment of Risk. Preclinical Treatment Evaluation. Prevention Trials. Protocols. QUOROM. Randomization. Randomized Treatment Assignment. Salk Vaccine. Sample Size Determination. Screening Trials. Sequential Methods. Society for Clinical Trials. Software. Statistical Review for Medical Journals. Statistical Review for Medical Journals, Guidelines for Authors. Statisticians in the Pharmaceutical Industry (PSI). Surrogate Endpoints. Textbooks. Time-varying Treatment Effect. Treatment--Covariate Interaction. University Group Diabetes Program (UGDP). Vaccine Studies.