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

Details

No. of pages:
796
Language:
English
Copyright:
© 2012
Published:
Imprint:
Academic Press
Print ISBN:
9780123821676
Electronic ISBN:
9780123821683

Reviews

PRAISE FOR THE FIRST EDITION:
"...much needed and provides essentially all of the basic information required by investigators involved in clinical research. ...an important resource for institutional libraries..."—THE NEW ENGLAND JOURNAL OF MEDICINE
"...it 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