Principles and Practice of Clinical Research

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

Readership

Individuals engaged in clinical research, including both students and scientific researchers as well as physicians and members of allied health professions

Table of Contents

1. A Historical Perspective on Clinical Research 

Part I - Ethical, Regulatory and Legal Issues
2. Ethical Principles in Clinical Research
3. Integrity in Research:  Principles for the Conduct of Research
4. Institutional Review Boards
5. The Regulation of Drugs and Biological Products by the Food and Drug Administration 
6. International Regulation of Drugs and Biological Products 
7. Data Management in Clinical Trials
8. Data and Safety Monitoring
9. Unanticipated Risk in Clinical Research
10. Legal Issues
11. Inclusion of Women and Minorities as Subjects in Clinical Research
12. Accreditation of Human Research Protection Programs
13. The Role and Importance of Clinical Trials Registries
14. The Clinical Researcher and the Media
15. Clinical Research: A Patient Perspective

Part II - Biostatistics and Epidemiology
16. Design of Observational Studies 
17. Design of Interventional Studies and Trials 
18. Issues in Randomization
19. Hypothesis Testing 
20. Power and Sample Size Calculations
21. An Introduction to Survival Analysis
22. Intermediate Topics in Biostatistics
23. Measures of Function and Health-Related Quality of Life
24. Large Clinical Trials and Registries:  Clinical Research Institutes
25. Meta-analysis of Clinical Trials
26. Using Large Datasets for Population-based Health Research
27. Development and Conduct of Studies

Part III - Technology Transfer, Protocol Development, and Sources of Funding Support for Research
28. Overview of Technology Development and Technology Transfer
29. Writing a Protocol
30. Evaluating a Protocol Budget
31. Clinical Research Data: Characteristics, Representation, Storage and Retrieval
32. Management of Patient Samples and Specimens
33. Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process
34. Clinical Research from the Industry Perspective
35. Philanthropy's Role in Advancing Biomedical Research

Part IV - Clinical Research Infrastructure
36. Managing Clinical Risk and Measuring Participants’ Perceptions of the Clinical Research Process
37. Clinical Pharmacology and its Role in Pharmaceutical Development 
38. Career Paths in Clinical Research
39. Clinical Research Nursing:  A New Domain of Practice
40. Issues and Challenges for Clinical Research in International Settings 
41. The Role of Comparative Effectiveness Research
42. The Importance and Use of Electronic Health Records in Clinical Research
43. Informational Resources for the Clinical Researcher