Essentials of Clinical Research 2nd Edition by Stephen Glasser 3319054694 9783319054698

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ISBN 10: 3319054694

ISBN 13: 9783319054698

Author: Stephen P. Glasser 

In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparationalong with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.

Essentials of Clinical Research 2nd Table of contents:

1. The Beginning – Historical Aspects of Clinical Research, Clinical Research: Definitions, “Anatomy and Physiology,” and the Quest for “Universal Truth”

2. Introduction to Clinical Research Concepts, Essential Characteristics of Clinical Research, Overview of Clinical Research Study Designs

3. A Focus on Clinical Trials

4. Alternative Interventional Study Designs

5. Phase 4 (Postmarketing) Research

6. The Role of the USA Food and Drug Administration in Clinical Research

7. The Placebo and Nocebo Effect

8. Recruitment and Retention in Clinical Research

9. Data Safety and Monitoring Boards (DSMBs)

10. Meta-analysis, Evidence-Based Medicine, and Clinical Guidelines

11. Research Methods for Genetic Studies

12. Research Methods for Pharmacoepidemiology Studies

13. Implementation Research: Beyond the Traditional Randomized Controlled Trial

14. Research Methodology for Studies of Diagnostic Tests

15. Statistical Power and Sample Size: Some Fundamentals for Clinician Researchers

16. Association, Cause, and Correlation

17. Bias, Confounding, and Effect Modification (Interaction)

18. It’s All About Uncertainty

19. Grant and Manuscript Writing

20. The Media and Clinical Research

21. Mentoring and Advising

22. Presentation Skills: How to Present Research Results

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