Principles and Practice of Clinical Research 4th Edition

Principles and Practice of Clinical Research 4th Edition – Ebook Instant Download/Delivery ISBN(s): 9780128499054,0128499052,9780128499047, 0128499044

Product details:

• ISBN 10:0128499044
• ISBN 13: 9780128499047
• Author:  John I. Gallin, Frederick P Ognibene, Laura Lee Johnson

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.

Table 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

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