Fundamentals of Clinical Trials

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

14 December, 2020

Fundamentals of Clinical Trials

Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, and Christopher B. Granger

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.

What Do You Think About This Book?

What is your opinion about Fundamentals of Clinical Trials? What did you like most? What are the strengths and weaknesses of this volume? 

Please share your comments below and give a more complete perspective to the clinical trial community!

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com