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Clinical Trials

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

  • 2nd Edition - February 19, 2016
  • Latest edition
  • Author: Tom Brody
  • Language: English

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomed… Read more

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Description

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

Readership

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

Product details

  • Edition: 2
  • Latest edition
  • Published: March 12, 2016
  • Language: English

About the author

TB

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)

View book on ScienceDirect

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