Gallin and Ognibene's 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. Anne Zajicek, M.D., Pharm.D., is a board-certified pediatrician and pediatric clinical pharmacologist who currently serves as Program Director of the Office of Clinical Research Education and Collaboration Outreach at the National Institutes of Health. Dr. Zajicek received a Bachelor’s degree in Pharmacy from Duquesne University and a PharmD from the State University of New York at Buffalo; completed a postdoctoral fellowship in the Department of Pharmaceutics of St. Jude Children’s Research Hospital; and served as an assistant professor at the University of Colorado School of Pharmacy and a Clinical Pharmacist at National Jewish Hospital and Research Center. In 1991, Dr. Zajicek entered medical school at the University of Pittsburgh, and in 1998 completed a residency in pediatrics at the Children’s Hospital of Pittsburgh. She practiced primary care pediatrics for two years and then continued her training as a pediatric clinical pharmacology fellow at Stanford University. She subsequently joined the U.S. Food and Drug Administration (FDA) in the Office of Clinical Pharmacology and Biopharmaceutics. She joined the Eunice Kennedy Shriver National Institute of Child Health and Human Development as a Pediatric Medical Officer in August 2003, and was appointed Chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch in 2010. Dr. Zajicek works to develop strategic partnerships with the extramural community and oversees clinical pharmacology and clinical research training programs. 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. HIV and COVID2. Ethical Principles in Clinical Research3. Integrity in Research: Principles for the Conduct of Research4. Institutional Review Boards5. Accreditation of Human Research Protection Programs6. The Regulation of Drugs and Devices by the Food and Drug Administration7. International Regulation of Drugs, Devices and Biologic Products8. Clinical Research in International Settings: The India and Pakistan Experience9. Clinical Research in International Settings: The South African Experience10. The Role and Importance of Clinical Trial Registries11. Data and Safety Monitoring12. Unanticipated Risk in Clinical Research13. Legal Issues in Clinical Research14. NIH Policy on the Inclusion of Women and Minorities and Diversity, Equity, Inclusion, and Accommodation in Clinical Research15. Vulnerable Populations16. Clinical Research: A Patient Perspective17. Patient Advocacy Groups and Rare Disease Research18. Development and Conduct of Studies19. Writing a Protocol20. Master Protocols21. Design of Observational Studies22. Design of Clinical Trials and Studies23. Role of Comparative Effectiveness Research24. Using Large Data Sets for Population Based Health Research25.Cha Measures of Function and Health related Quality of Life26. Incorporating Clinical Outcome Assessment into Endpoints for Decision Making27. Meta-Analysis of Clinical Trials28. Issues of Randomization29. Hypothesis Testing30. Power and Sample Size Calculations31. An Introduction to Survival Analysis32. Advanced Topics in Biostatistics33. Large Clinical Trials--Registries. Clinical Research Institutes34. Special Challenges Facing the Clinical Investigator Conducting a Clinical Trial from Start to Finish. The Meropoenem experience35. Intellectual Property and Technology Transfer36. Clinical Research Data: Characteristics, Representation, Storage and Retrieval37. Data Management in Clinical Trials38. Importance and use of Electronic Health Records39. Management of Patient Samples40. Evaluating a Protocol Budget41. Getting the Funding you Need to Support your Research. Navigating the National Institutes of Health Peer Review Process42. Philanthropy’s Role in Advancing Biomedical Research43. Preclinical animal studies44. Clinical Pharmacology and Its Role in Pharmaceutical Development45. Identifying, Understanding and Management of Patient Safety and Clinical Risks46. Career Paths in Clinical Research47. Opportunities for Surgeons in Clinical Research48. Clinical Research Nursing49. Preparing for the Next Pandemic/Emergency Preparedness50. Clinical Research and the Media51. Information Resources for the Clinical Researcher