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Elsevier

Principles and Practice of Clinical Research

  • 4th Edition - November 16, 2017
  • Newer edition is available
  • Editors: John I. Gallin, Frederick P Ognibene, Laura Lee Johnson
  • Language: English

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice… Read more

Description

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications.

In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic” platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research.

Key features

  • Features input from experts in the field dedicated to translating scientific research from bench to bedside and back
  • Provides expanded coverage of global clinical research
  • Contains hands-on, practical suggestions, illustrations, and examples throughout
  • Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Readership

Individuals engaged in clinical research, including both students and scientific researchers as well as physicians and members of allied health professions

Table of contents

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

Product details

About the editors

JG

John I. Gallin

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.
Affiliations and expertise
Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health, Bethesda, MD, USA

FO

Frederick P Ognibene

Affiliations and expertise
MD, MCCM, FACP, Deputy Director, Educational Affairs and Strategic Partnerships, NIH Clinical Center and Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA

LJ

Laura Lee Johnson

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.
Affiliations and expertise
Associate Director, Division of Biometrics III, FDA/CDER Office of Biostatistics, Silver Spring, MD, USA

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