Fundamentals of Clinical Trials is a book published by Springer in 2015 (5th Edition) and written by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, and Christopher B. Granger.

Book Purpose & Audience

Fundamentals of Clinical Trials seeks to help clinical investigators in improving the quality of their clinical trials by discussing fundamental elements of clinical studies with real-life examples. 

This book has in mind clinical researchers with some clinical trial expertise and those who are planning their first clinical trial.

Moreover, this volume can be used to teach basic clinical trial methods and to help the medical community involved in assessing published reports of clinical studies.

This book is not deeply technical, but it can be useful as a guide for graduate courses in clinical research.

Book Contents

This 550-page book contains 22 chapters covering the following topics:

1. Introduction to clinical trials
2. Ethical issues
3. What is the question?
4. Study population
5. Basic study design
6. The randomization process
7. Blinding
8. Sample size
9. Baseline assessment
10. Recruitment of study participants
11. Data collection and quality control
12. Assessment and reporting of harm
13. Assessment of health related quality of life
14. Participant adherence
15. Survival analysis
16. Monitoring committee structure and function
17. Statistical methods used in interim monitoring
18. Issues in data analysis
19. Closeout
20. Reporting and interpreting of results
21. Multicenter trials
22. Regulatory issues

About the Authors

• Lawrence M. Friedman: North Bethesda, Doctor of Medicine.
• Curt D. Furberg: Professor Emeritus, Wake Forest School of Medicine, Division of Public Health Sciences.
• David L. DeMets: Professor Emeritus, Biostatistics and Medical Informatics Department, School of Medicine and Public Health, University of Wisconsin-Madison.
• David M. Reboussin: Professor, Biostatistics and Data Science, Wake Forest School of Medicine.
• Christopher B. Granger: Professor of Medicine, Member in the Duke Clinical Research Institute, Department of Medicine, Duke University School of Medicine.

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