Gallin and Ognibene's Principles and Practice of Clinical Research,

Edition 5

Editors: Edited by John I. Gallin, MD, Anne Zajicek, MD, PharmD, FAAP and Laura Lee Johnson, PhD

Publication Date: 01 Jun 2026

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Gallin and Ognibene’s Principles and Practice of Clinical Research, Fifth Edition provides the definitive text on clinical research as written by internationally recognized experts from the National Institutes of Health, the US Food and Drug Administration, academia, and global researchers. This new edition contains more than 30 new authors and 9 new chapters. Topics covered emphasize the role of informatics in clinical research, incorporating clinical outcome assessment into endpoints for decision-making, inclusion of diverse and vulnerable research subjects, patient advocacy groups, rare disease research, preparing research for pandemics, public health emergencies, research opportunities for surgeons, and content on preclinical animal studies.

For the international researcher, two new chapters detail international clinical research experiences in South Africa, India, and Pakistan. As with the previous edition, the new release provides readers with summary questions and answers after each chapter.

Key Features

Includes two new chapters that detail international clinical research experiences in South Africa, India, and Pakistan
Facilitates the translation of scientific research from bench to bedside and back
Contains fully updated chapters, more than 30 new authors, and 9 new chapters
Provides expanded coverage of global clinical research, including HIV and COVID

About the author

Edited by John I. Gallin, MD, Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health, Bethesda, MD, USA; Anne Zajicek, MD, PharmD, FAAP, National Institute of Health, Maryland, USA and Laura Lee Johnson, PhD, Associate Director, Division of Biometrics III, FDA/CDER Office of Biostatistics, Silver Spring, MD, USA

1. HIV and COVID
2. Ethical Principles in Clinical Research
3. Integrity in Research: Principles for the Conduct of Research
4. Institutional Review Boards
5. Accreditation of Human Research Protection Programs
6. The Regulation of Drugs and Devices by the Food and Drug Administration
7. International Regulation of Drugs, Devices and Biologic Products
8. Clinical Research in International Settings: The India and Pakistan Experience
9. Clinical Research in International Settings: The South African Experience
10. The Role and Importance of Clinical Trial Registries
11. Data and Safety Monitoring
12. Unanticipated Risk in Clinical Research
13. Legal Issues in Clinical Research
14. NIH Policy on the Inclusion of Women and Minorities and Diversity, Equity, Inclusion, and Accommodation in Clinical Research
15. Vulnerable Populations
16. Clinical Research: A Patient Perspective
17. Patient Advocacy Groups and Rare Disease Research
18. Development and Conduct of Studies
19. Writing a Protocol
20. Master Protocols
21. Design of Observational Studies
22. Design of Clinical Trials and Studies
23. Role of Comparative Effectiveness Research
24. Using Large Data Sets for Population Based Health Research
25.Cha Measures of Function and Health related Quality of Life
26. Incorporating Clinical Outcome Assessment into Endpoints for Decision Making
27. Meta-Analysis of Clinical Trials
28. Issues of Randomization
29. Hypothesis Testing
30. Power and Sample Size Calculations
31. An Introduction to Survival Analysis
32. Advanced Topics in Biostatistics
33. Large Clinical Trials--Registries. Clinical Research Institutes
34. Special Challenges Facing the Clinical Investigator Conducting a Clinical Trial from Start to Finish. The Meropoenem experience
35. Intellectual Property and Technology Transfer
36. Clinical Research Data: Characteristics, Representation, Storage and Retrieval
37. Data Management in Clinical Trials
38. Importance and use of Electronic Health Records
39. Management of Patient Samples
40. Evaluating a Protocol Budget
41. Getting the Funding you Need to Support your Research. Navigating the National Institutes of Health Peer Review Process
42. Philanthropy’s Role in Advancing Biomedical Research
43. Preclinical animal studies
44. Clinical Pharmacology and Its Role in Pharmaceutical Development
45. Identifying, Understanding and Management of Patient Safety and Clinical Risks
46. Career Paths in Clinical Research
47. Opportunities for Surgeons in Clinical Research
48. Clinical Research Nursing
49. Preparing for the Next Pandemic/Emergency Preparedness
50. Clinical Research and the Media
51. Information Resources for the Clinical Researcher

ISBN: 9780443333279

Page Count: 1000

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Investigators involved in clinical research including both students and scientific researchers as well as physicians and members of allied health professions