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Clinical Trials - 2nd Edition - ISBN: 9780128042175, 9780128042588

Clinical Trials

2nd Edition

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

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Author: Tom Brody
Hardcover ISBN: 9780128042175
eBook ISBN: 9780128042588
Imprint: Academic Press
Published Date: 12th March 2016
Page Count: 896
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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. 

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


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

Table of Contents

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


No. of pages:
© Academic Press 2016
12th March 2016
Academic Press
Hardcover ISBN:
eBook ISBN:

About the Author

Tom Brody

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 Clinical Trials, 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.

Affiliations and Expertise

Consultant for Second Genome, Inc. (Crohn's disease), Rigel Pharmaceuticals (platelet disorder), PrimeGen Biotech (stem cell therapy), Regeneron Pharmaceuticals (broadly neutralizing antibodies for HIV), and Biogen IDEC (multiple sclerosis)

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