Principles and Practice of Clinical Research

Edited by

  • John Gallin, M.D., Director, NIH Clinical Center and NIH Associate Director for Clinical Research, Bethesda, MD
  • Frederick Ognibene, 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

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.
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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


Book information

  • Published: May 2012
  • ISBN: 978-0-12-382167-6


"...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

Table of Contents

  • A Historical Perspective on Clinical Research

Part I- Ethical, Regulatory and Legal Issues

  • Ethical Principles in Clinical Research
  • Researching a Bioethical Question
  • Integrity in Research: Individual & Institutional Responsibility
  • Institutional Review Boards
  • The Role of Independent Institutional Review Boards
  • The Regulation of Drugs and Biological Products by the Food and Drug Administration
  • Data Management in Clinical Trials
  • Data and Safety Monitoring Boards
  • Unanticipated Risk in Clinical Research
  • Legal Issues
  • Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research
  • National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
  • Accreditation of Human Research Protection Programs
  • The Role and Importance of Clinical Trials Registries
  • The Clinical Researcher and the Media
  • Clinical Research: A Patient Perspective

Part II- Biostatistics and Epidemiology

  • Design of Observational Studies
  • Design of Clinical Studies and Trials
  • Issues in Randomization
  • Overview of Hypothesis Testing
  • Introduction to Sample Size Calculation and Power
  • An Introduction to Survival Analysis
  • Intermediate Topics in Biostatistics
  • Measures of Function and Health-Related Quality of Life
  • Large Clinical Trials and Registries: Clinical Research Institutes
  • Meta-analysis of Clinical Trials
  • Using Large Datasets for Population-based Health Research
  • Development and Conduct of Studies

Part III- Technology Transfer, Protocol Development, and Funding

  • Overview of Technology Development
  • Patents and Patent Licenses
  • Writing a Protocol
  • Evaluating a Protocol Budget
  • Clinical Research Data: Characteristics, Representation, Storage and Retrieval
  • Management of Patient Samples and Specimens
  • Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health
  • Peer Review Process
  • Clinical Research from the Industry Perspective
  • The Role of Private Foundations in the Support and Funding of Clinical Research
  • Use of Questionnaires and Patient Surveys in Clinical Research
  • Integration of Specialized Research Services into Clinical Laboratory Operations
  • Use of Imaging Tools and Techniques
  • Role of Blood Bank and Transfusion Medicine in Clinical Research
  • Clinical Pharmacology and its Role in Pharmaceutical Development
  • Career Paths in Clinical Research
  • Clinical Research Nursing: A New Domain of Practice
  • Clinical Research in a Community-based Setting
  • Issues and Challenges for Clinical Research in International Settings
  • Power of an Undiagnosed Disease Program in a Clinical Research Enterprise
  • Human Genome Project, Genomics, and Clinical Research
  • Harnessing Information Utilizing Genomic Platforms