Essentials of Clinical Research (2^nd Ed., Softcover reprint of the original 2nd ed. 2014)

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 preparation along 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.

Preface

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

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

3. A Focus on Clinical Trials
Stephen P Glasser  

4. Alternative Interventional Study Designs
Stephen P Glasser

5. Phase 4 (Postmarketing) Research
Stephen P Glasser , Elizabeth Delzell, Maribel Salas 

6. The Role of the USA Food and Drug Administration in Clinical Research
Stephen P Glasser, Carol M. Ashton, Nelda P. Wray 

7. The Placebo and Nocebo Effect
Stephen P Glasser, William Frishman 

8. Recruitment and Retention in Clinical Research
Stephen P Glasser  

9. Data Safety and Monitoring Boards (DSMBs)
Stephen P Glasser MD, O. Dale Williams  

10. Meta-analysis, Evidence Based Medicine, and Clinical Guidelines
Stephen P Glasser, Sue Duval 

11. Research Methods for Genetic Studies
Sadeep Shrestha, Donna K Arnett 

12. Research Methods for Pharmacoepidemiology Studies
Maribel Salas, Bruno Stricker 

13. Implementation Research: Beyond the Traditional Randomized Controlled Trial
Amanda H. Salanitro, Lauren Powell, Carlos A. Estrada

14. Research Methodology for Studies of Diagnostic Tests
Stephen P Glasser

15. Statistical Power & Sample Size: Some Fundamentals For Clinician Researchers
J. Michael Oakes 

16. Association, Cause, and Correlation
Stephen P Glasser, Gary Cutter                

17. Bias, Confounding, and Effect Modification (Interaction)
Stephen P Glasser                

18. It’s All About Uncertainty
Stephen P Glasser, George Howard  

19. Grant and Manuscript Writing
Donna K Arnett  

20. The Media and Clinical Research
Stephen P Glasser MD    

21. Mentoring and the Mentee
Stephen P Glasser, Edward W Hook III    

22. Presentation Skills: How to Present Research Results
Stephen P Glasser

Thoroughly updated and expanded for the Second Edition

Includes new material on the net reclassification index; the p value and Bayesian approaches and more

Offers new discussion of clinical practice guidelines and the different ways of grading evidence

Includes supplementary material: sn.pub/extras