Understanding Clinical Research

Abstract

Complete how-to guidance on conducting clinical research, this book addresses the operational challenges of clinical trials and provides a clear explanation of the methodologies necessary to interpret results. The book addresses all aspects of clinical trials, from design and implementation to statistics to regulatory scrutiny. A resource for students, residents, and clinicians who need a working knowledge of clinical research principles. The chapter authors are all leaders in the field and engaged in cutting edge clinical research. Use as a textbook, as a reference, and as a course guide for mandated clinical research training courses. A brief history of clinical trials, drug regulations, and the Food and Drug Administration / Nidhi Tripathy [and 3 others] -- Information technology, access, clinicaltrials.gov / Anjan Chakrabarti and C. Michael Gibson -- The role of academic research organizations in clinical research / Craig J. Reist [and 3 others] -- Ethics of clinical research : an overview and emerging issues / Yee Weng Wong and Kevin A. Schulman -- Introduction to clinical experimentation / Robert Bigelow -- Phase I trials : first in human / Kevin M. Watt, Karen Chiswell, and Michael Cohen-Wolkoweiz -- Phase II clinical trials / Jeffrey T. Guptill and Karen Chiswell -- Phase III and IV clinical trials / Gail E. Hafley, Sergio Leonardi, and Karen S. Pieper -- Challenges of clinical trials in pediatrics / Kevin N. Turner and P. Brian Smith -- Observational research / Michaela Dinan -- Data resources / Ying Xian -- Observational study designs / Bradley G. Hammill -- Challenges of observational designs / David M. Vock -- Specific regression techniques / Phillip J. Schulte -- Analytical methods of addressing confounding / Eric M. Reyes -- Lessons from notable examples in observational research / Zubin Eapen and Lesley H. Curtis.