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


No. of pages:
© 2012
Academic Press
Print ISBN:
Electronic ISBN:


"...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