Principles and Practice of Clinical Research

Principles and Practice of Clinical Research

4th Edition - November 16, 2017

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  • Editors: John Gallin, Frederick Ognibene, Laura Lee Johnson
  • eBook ISBN: 9780128499047
  • Hardcover ISBN: 9780128499054

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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


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

  • No. of pages: 824
  • Language: English
  • Copyright: © Academic Press 2017
  • Published: November 16, 2017
  • Imprint: Academic Press
  • eBook ISBN: 9780128499047
  • Hardcover ISBN: 9780128499054

About the Editors

John Gallin

Affiliations and Expertise

Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health, Bethesda, MD

Frederick 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

Laura Lee Johnson

Affiliations and Expertise

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

Ratings and Reviews

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  • Paola C. Thu Sep 08 2022

    Positive purcahse

    I was able to quickly complete the purchase process. I received an emial notification and got the e-book shortly after.

  • David T. Sun Jul 31 2022


    A good read on the topic

  • Erika Fri Mar 23 2018


    This book can really provide you with in-depth analysis and useful information about clinical research. In fact, I think the book deserves a place among the most useful books on clinical research that are listed here: