Master all aspects of clinical research design with the field's leading reference!

Designing Clinical Research, Fourth Edition

Reflecting the combined expertise of the research field’s leading authorities, Designing Clinical Research, Fourth Edition is an indispensable tool for clinical research design in all its many variations—clinical trials, observational epidemiology, translational science, patient-oriented research, behavioral science and health services research.

This standard reference presents advanced epidemiologic concepts in a reader-friendly way and suggests common sense approaches to the challenging judgments involved in how to design, fund and implement a clinical trial.

You will find expanded content in every chapter with new material on:

• non-inferiority trials for comparative effectiveness research
• incidence-density case-control studies
• confounding and effect modification
• diagnostic test studies to inform prediction rules
• ethical aspects of whole genome sequencing
• automated data management approaches
• new NIH grant writing requirements
• full color treatment throughout
• access to teaching materials, new data



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Designing Clinical Research, Fourth Edition

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Meet the Authors

Dr. Stephen B. Hulley

Dr. Stephen B. Hulley is a physician epidemiologist who received his MD from Harvard Medical School and his MPH from the UC Berkeley School of Public Health. He has held faculty positions at Stanford University and at the University of California, San Francisco (UCSF) where he chaired the Department of Epidemiology and Biostatistics. Dr Hulley has created and led numerous large studies including the NIH-funded $100 million multicenter Coronary Artery Risk Development In young Adults (CARDIA) cohort study, and the $50 million 20-Center Heart and Estrogen-progestin Replacement Study (HERS), a randomized blinded trial of cardiovascular disease prevention.

Dr. Steven R. Cummings

Dr. Steven R. Cummings is the Founding Director, of San Francisco Coordinating Center (SFCC). During the past 30 years he has led numerous large NIH and Industry-sponsored studies and clinical trials about the causes and prevention of many age-related conditions including osteoporosis, breast cancer, and human longevity. He has pioneered several innovations in the conduct of clinical trials, including the first online clinical trials. Steve has published over 500 original articles and he has been elected to the Institute of Medicine (IOM) of the U.S. National Academy of Sciences for his work in clinical research and women’s health.

Dr. Deborah Grady

Dr. Deborah Grady is Professor of Medicine, Associate Dean for Clinical and Translational Research., Co-Director of the Clinical and Translational Sciences Institute (CTSI) and Director of the CTSI Training Program and the University of California San Francisco. She is Deputy Editor of JAMA Internal Medicine and an elected member of the Institute of Medicine.

Dr. Tom Newman

Dr. Tom Newman is Professor of Epidemiology & Biostatistics and Pediatrics and Chief of the Division of Clinical Epidemiology at the University of California, San Francisco School of Medicine. His research over the past 30 years has applied principles of evidence-based medicine to common clinical problems in pediatrics, including jaundice in newborns, childhood cholesterol screening, and urinary tract and other infections in infants.

Dr. Warren S. Browner

Dr. Warren S. Browner, M.D., M.P.H. has been the Chief Executive Officer of California Pacific Medical Center since May 4, 2009 and also serves as its Executive Management Member. Mr. Browner serves as the Vice President of Academic Affairs at St. Luke's Hospital. He served as Vice President of Academic Affairs at California Pacific Medical Center, a subsidiary of Sutter Health Corporation. He joined the multi-campus San Francisco hospital nine years ago as the first Scientific Director of its CPMC Research Institute. Prior to CPMC, Mr. Browner was a practicing general internist, Chief of General Internal Medicine, and acting Chief of the Medical Service at the San Francisco VA Medical Center. He was also Professor of Medicine, epidemiology and biostatistics at the University of California, San Francisco, and an Executive Editor of the American Journal of Medicine. His research focuses on the genetics of human longevity, according to CPMC, and he is the author of several books and numerous articles in scholarly journals. Mr. Browner recently initiated a collaboration between CPMC and Dartmouth Medical School. He serves as a Director and Scientific Advisor of Surgery of PeriCor Therapeutics, Inc. Mr. Browner holds a medical degree from UCSF and master's degree in Public Health from the University of California, Berkeley.

Book Details

Designing Clinical Research, Fourth Edition

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    July 2013
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