Principles and Practice of Clinical Research (4th Edition)

Description

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

Table of Contents

1. A Historical Perspective on Clinical Research
2. Part I – Ethical, Regulatory and Legal Issues
   1. Ethical Principles in Clinical Research
   2. Integrity in Research:  Principles for the Conduct of Research
   3. Institutional Review Boards
   4. The Regulation of Drugs and Biological Products by the Food and Drug Administration
   5. International Regulation of Drugs and Biological Products
   6. Data Management in Clinical Trials
   7. Data and Safety Monitoring
   8. Unanticipated Risk in Clinical Research
   9. Legal Issues
   10. Inclusion of Women and Minorities as Subjects in Clinical Research
   11. Accreditation of Human Research Protection Programs
   12. The Role and Importance of Clinical Trials Registries
   13. The Clinical Researcher and the Media
   14. Clinical Research: A Patient Perspective
3. Part II – Biostatistics and Epidemiology
   1. Design of Observational Studies
   2. Design of Interventional Studies and Trials
   3. Issues in Randomization
   4. Hypothesis Testing
   5. Power and Sample Size Calculations
   6. An Introduction to Survival Analysis
   7. Intermediate Topics in Biostatistics
   8. Measures of Function and Health-Related Quality of Life
   9. Large Clinical Trials and Registries:  Clinical Research Institutes
   10. Meta-analysis of Clinical Trials
   11. Using Large Datasets for Population-based Health Research
   12. Development and Conduct of Studies
4. Part III – Technology Transfer, Protocol Development, and Sources of Funding Support for Research
   1. Overview of Technology Development and Technology Transfer
   2. Writing a Protocol
   3. Evaluating a Protocol Budget
   4. Clinical Research Data: Characteristics, Representation, Storage and Retrieval
   5. Management of Patient Samples and Specimens
   6. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process
   7. Clinical Research from the Industry Perspective
   8. Philanthropy’s Role in Advancing Biomedical Research
5. Part IV – Clinical Research Infrastructure
   1. Managing Clinical Risk and Measuring Participants’ Perceptions of the Clinical Research Process
   2. Clinical Pharmacology and its Role in Pharmaceutical Development
   3. Career Paths in Clinical Research
   4. Clinical Research Nursing:  A New Domain of Practice
   5. Issues and Challenges for Clinical Research in International Settings
   6. The Role of Comparative Effectiveness Research
   7. The Importance and Use of Electronic Health Records in Clinical Research
   8. Informational Resources for the Clinical Researcher

Editors Biography

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