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. Laura Lee Johnson, Ph.D. is the patient focused drug development liaison and the division director for the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, implementation, and analysis of research studies of all sizes and in measurement tool and endpoint development. Prior to working at the FDA she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.

1. A Historical Perspective on Clinical Research 

Part I - Ethical, Regulatory and Legal Issues 2. Ethical Principles in Clinical Research 3. Integrity in Research:  Principles for the Conduct of Research 4. Institutional Review Boards 5. The Regulation of Drugs and Biological Products by the Food and Drug Administration 6. International Regulation of Drugs and Biological Products 7. Data Management in Clinical Trials 8. Data and Safety Monitoring 9. Unanticipated Risk in Clinical Research 10. Legal Issues 11. Inclusion of Women and Minorities as Subjects in Clinical Research 12. Accreditation of Human Research Protection Programs 13. The Role and Importance of Clinical Trials Registries 14. The Clinical Researcher and the Media 15. Clinical Research: A Patient Perspective

Part II - Biostatistics and Epidemiology 16. Design of Observational Studies 17. Design of Interventional Studies and Trials 18. Issues in Randomization 19. Hypothesis Testing 20. Power and Sample Size Calculations 21. An Introduction to Survival Analysis 22. Intermediate Topics in Biostatistics 23. Measures of Function and Health-Related Quality of Life 24. Large Clinical Trials and Registries:  Clinical Research Institutes 25. Meta-analysis of Clinical Trials 26. Using Large Datasets for Population-based Health Research 27. Development and Conduct of Studies

Part III - Technology Transfer, Protocol Development, and Sources of Funding Support for Research 28. Overview of Technology Development and Technology Transfer 29. Writing a Protocol 30. Evaluating a Protocol Budget 31. Clinical Research Data: Characteristics, Representation, Storage and Retrieval 32. Management of Patient Samples and Specimens 33. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process 34. Clinical Research from the Industry Perspective 35. Philanthropy's Role in Advancing Biomedical Research

Part IV - Clinical Research Infrastructure 36. Managing Clinical Risk and Measuring Participants’ Perceptions of the Clinical Research Process 37. Clinical Pharmacology and its Role in Pharmaceutical Development 38. Career Paths in Clinical Research 39. Clinical Research Nursing:  A New Domain of Practice 40. Issues and Challenges for Clinical Research in International Settings 41. The Role of Comparative Effectiveness Research 42. The Importance and Use of Electronic Health Records in Clinical Research 43. Informational Resources for the Clinical Researcher