Principles and Practice of Clinical Research

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications.

In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic” platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research.

• Features input from experts in the field dedicated to translating scientific research from bench to bedside and back
• Provides expanded coverage of global clinical research
• Contains hands-on, practical suggestions, illustrations, and examples throughout
• Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Dr.John Gallin served as Director of the NIH Clinical Center (1994–2017) and later as NIH Associate Director for Clinical Research. He led the development of the Mark O. Hatfield Clinical Research Center and global training programs. His research focused on rare immune disorders, and he published extensively. Dr. Gallin was the founder of the Introduction to the Principles and Practice of Clinical Research course at the NIH. Dr. Gallin passed away in 2024.

Laura Lee Johnson is a Division Director for the Office of Biostatistics at the FDA’s Center for Drug Evaluation and Research. She specializes in study design and endpoint development and spent over a decade at NIH overseeing clinical research programs.