Principles and Practice of Clinical Research

3rd Edition

Editors: John Gallin Frederick Ognibene
Hardcover ISBN: 9780123821676
eBook ISBN: 9780123821683
Imprint: Academic Press
Published Date: 31st May 2012
Page Count: 796
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Institutional Access


The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.

Key Features

  • Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research
  • Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research
  • Delves into data management and addresses how to collect data and use it for discovery
  • Contains valuable, up-to-date information on how to obtain funding from the federal government


All individuals engaged in clinical research both student and researcher as well as physicians, dental investigators, PhD basic scientists, and members of allied health professions

Table of Contents




Chapter 1. A Historical Perspective on Clinical Research

The Earliest Clinical Research

Greek and Roman Influence

Middle Ages and Renaissance

Seventeenth Century

Eighteenth Century

Nineteenth Century

Twentieth Century and Beyond


Summary Questions


Part I Ethical, Regulatory and Legal Issues

Chapter 2. Ethical Principles in Clinical Research

Distinguishing Clinical Research from Clinical Practice

What does Ethics have to do with Clinical Research?

History of Ethical Attention to Clinical Research

Codes of Research Ethics and Regulations

Ethical Framework for Clinical Research

Ethical Considerations in Randomized Clinical Trials


Summary Questions


Chapter 3. Researching a Bioethical Question

Types of Bioethical Issues

Types of Bioethical Research Methodologies

Examples of Important Bioethical Research

Special Considerations in Bioethical Research


Chapter 4. Integrity in Research

Guidelines for the Conduct of Research

Scientific Integrity and Misconduct

Mentor–Trainee Relationships

Data Acquisition, Management, Sharing, and Ownership

Research Involving Human and Animal Subjects

Collaborative Science

Conflict of Interest and Commitment

Peer Review

Publication Practices and Responsible Authorship


Summary Questions


Chapter 5. Institutional Review Boards

Historical, Ethical, and Regulatory Foundations of Current Requirements for Research Involving Human Subjects

Institutional Review Boards

Clinical Researchers and IRBS

The Current IRB System Under Evaluation


No. of pages:
© Academic Press 2012
Academic Press
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About the Editor

John Gallin

Affiliations and Expertise

M.D., Director, NIH Clinical Center and NIH Associate Director, Clinical Research, Bethesda, MD, USA

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


"...much needed and provides essentially all of the basic information required by investigators involved in clinical research. important resource for institutional libraries..."—THE NEW ENGLAND JOURNAL OF MEDICINE
" really is a step-by-step DIY book for the uninitiated proposal writer. Full of practical advice, top tips and the ever-useful 'Supplemental reading' section, it even has a sample face sheet and a study design 'tick list'."--IMMUNOLOGY NEWS

"Principles and Practice of Clinical Research, 3rd Edition is 80% larger than the second edition.  Most of the authors are with the National Institutes of Health, but the material is largely applicable to both government- and industry-funded research…This book has been selected for The First Clinical Research Bookshelf, essential reading for clinical research professionals."--Journal of Clinical Research Best Practices, May 2013