Gallin and Ognibene's Principles and Practice of Clinical Research
- 5th Edition - January 1, 2027
- Latest edition
- Editors: John I. Gallin, Anne Zajicek, Laura Lee Johnson
- Language: English
Gallin and Ognibene’s Principles and Practice of Clinical Research, Fifth Edition provides the definitive text on clinical research as written by internationally recognized e… Read more
Description
Description
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.
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
Key features
- Study design considerations
- Statistical concepts relevant to clinical research
- Patient and community engagement
- Engagement of patient advocacy and rare disease organizations
- Preparing for clinical research during public health emergencies
- Incorporating clinical outcome assessments into endpoints for decision-making
- Research opportunities for clinical researchers in various medical fields
- Written and edited by experts in the field and dedicated to facilitating the translation of scientific research from bench to bedside and back
Readership
Readership
Investigators involved in clinical research including both students and scientific researchers as well as physicians and members of allied health professions
Table of contents
Table of contents
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
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
Product details
Product details
- Edition: 5
- Latest edition
- Published: January 1, 2027
- Language: English
About the editors
About the editors
JG
John I. Gallin
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.
Affiliations and expertise
Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health, Bethesda, MD, USAAZ
Anne Zajicek
Dr. Anne Zajicek is a pediatrician and clinical pharmacologist who directed the Office of Clinical Research Education and Collaboration Outreach at NIH. She previously held leadership roles at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, focusing on pediatric and obstetric pharmacology and research training.
Affiliations and expertise
National Institute of Health, Maryland, USALJ
Laura Lee Johnson
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.
Affiliations and expertise
Associate Director, Division of Biometrics III, FDA/CDER Office of Biostatistics, Silver Spring, MD, USA