Clinical Trials

Clinical Trials, 2nd Edition

Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Clinical Trials, 2nd Edition,Tom Brody,ISBN9780128042175
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Academic Press




235 X 191

A hands-on guidebook that integrates the most practical aspects of clinical trial design with important content on laboratory studies of human data, patient safety, regulatory requirements and much more

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Key Features

  • Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more
  • Extensively covers the "study schema" and related features of study design
  • Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials
  • Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers


Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. 


Researchers, physicians, nurses, pharmacists who plan and run clinical trials, members of the American Medical Writers Association, pharmaceutical and biotechnology industry scientists, pharmacology and pharmaceutical science students, pharmacy students and medical students

Tom Brody


Dr. Tom Brody received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at University of Wisconsin-Madison and also at U.C. Berkeley. His 20 research publications concern the metabolism and pharmacology of folates, cloning an anti-cancer gene (XPE gene), and the structure of an antibody (natalizumab) used for treating multiple sclerosis. The author has 15 years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Elan Pharmaceuticals, and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C. At an earlier time, he wrote two editions of Nutritional Biochemistry, published by Elsevier, Inc. The author has 16 years of training and experience in the Code of Federal regulations, as it applies to pharmaceuticals and clinical trial design.

View additional works by Tom Brody

Clinical Trials, 2nd Edition


  1. The Origins of Drugs
  2. Introduction to Clinical Trial Design
  3. Run-in Period
  4. Inclusion/Exclusion Criteria, Stratification and Subgroups – Part I
  5. Inclusion and Stratification Criteria – Part II
  6. Randomization, Allocation, and Binding
  7. Intent to Treat Analysis vs. Per Protocol Analysis
  8. Biostatistics – Part I
  9. Biostatistics – Part II
  10. Introduction to Endpoints for Clinical Trials in Pharmacology
  11. Endpoints in Clinical Trials on Solid Tumors – Objective Response
  12. Oncology Endpoints: Overall Survival and Profession-Free Survival
  13. Oncology Endpoints:  Time to Progression
  14. Oncology Endpoint: Disease-Free Survival
  15. Oncology Endpoint: Time to Distant Metastasis
  16. Neoadjuvant Therapy vs. Adjuvant Therapy
  17. Hematological Cancers
  18. Biomarkers and Personalized Medicine
  19. Endpoints in Immune Diseases
  20. Endpoints in Clinical Trials on Infections
  21. Health-Related Quality of Life
  22. Health-Related Quality of Life Instruments for Immune Disorders
  23. Health-Related Quality of Life Instruments and Infections
  24. Drug Safety
  25. Mechanisms of Action, Part I
  26. Mechanisms of Action, Part II – Cancer
  27. Mechanisms of Action, Part III – Immune Disorders
  28. Mechanisms of Action, Part IV- Infections
  29. Consent Forms
  30. Package Inserts
  31. Regulatory Approval
  32. Patents
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