Principles and Practice of Clinical Research

Dr. John Gallin was appointed to the dual roles of National Institutes of Health (NIH) Associate Director for Clinical Research and inaugural Chief Scientific Officer, the Clinical Center in August 2016. He served as the Director NIH Clinical Center from 1994-2017 after serving 9 years as Scientific Director of the National Institute of Allergy and Infectious Diseases (NIAID) and 12 years as Chief of the Laboratory of Host Defenses. During his tenure as Director of the NIH Clinical Center, Dr. Gallin helped to lead the design, construction, and activation of the Mark O. Hatfield Clinical Research Center, the largest hospital in the world totally dedicated to clinical research. He also oversaw the establishment of a new curriculum for clinical research training, now offered globally reaching over 25,000 students annually in 168 countries, and the development of new information systems for biomedical, translational and clinical research. In 2011, Dr. Gallin accepted, on behalf of the NIH Clinical Center, the Lasker–Bloomberg Public Service Award for its rich history of medical discovery through clinical research. His primary research interests are rare immune disorders of phagocytes, with a focus on chronic granulomatous disease (CGD). His laboratory described the genetic basis for several forms of CGD and other disorders of phagocytes and has done pioneering research that has reduced life-threatening bacterial and fungal infections in patients with these disorders. He has published more than 380 articles in scientific journals and edited two textbooks – Inflammation, Basic Principles and Clinical Correlates (Lippincott, Williams, and Wilkins, 1999, 3rd edition) and Principles and Practice of Clinical Research (Academic Press, 4th edition 2018). He has received numerous awards and honors for his accomplishments and in 2022 received the Weill Cornell Medical College Alumni Award of Distinction, the medical college’s most prestigious alumni award. Dr. Gallin is a member of the American Society for Clinical Investigation, the Association of American Physicians, the National Academy of Medicine of the National Academy of Sciences, a Master of the American College of Physicians, and a Fellow of the Royal College of Physicians-London. He retired from his administrative positions in 2023 and is now an Adjunct Senior Investigator at NIH in the Laboratory of Clinical Immunology and Microbiology in the National Institute of Allergy and Infectious Diseases.

•A Historical Perspective on Clinical Research
ETHICAL, REGULATORY, AND LEGAL ISSUES
•Ethical Principles in Clinical Research
•Researching a Bioethical Question
•Integrity in Research: Individual and Institutional Responsibility
•Institutional Review Boards
•Data and Safety Monitoring Boards
•Data Management in Clinical Trials
•Unanticipated Risks in Clinical Research
•The Regulation of Drugs and Biological Products by the Food and Drug Administration
•Legal Issues
•Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research
•National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
•Clinical Research: A Patient Perspective
•The Clinical Researcher and the Media
BIOSTATISTICS AND EPIDEMIOLOGY
•An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation
•Design and Conduct of Observational Studies and Clinical Trials
•Small Clinical Trials
•Large Clinical Trials and Registries - Clinical Research Institutes
•Using Secondary Data in Statistical Analysis
•An Introduction to Survival Analysis
•Measures of Function and Health-Related Quality of Life
TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES
•Overview of Technology Development
•Technology Transfer
•Writing a Protocol
•Evaluating a Protocol Budget
•Data Management in Clinical Research: General Principles and a Guide to Sources
•Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process
•Clinical Research from the Industry Perspective
•Human Genome Project, Genomics, and Clinical Research