Clinical Trials

1st Edition

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

Authors: Tom Brody
Hardcover ISBN: 9780123919113
eBook ISBN: 9780123919137
Imprint: Academic Press
Published Date: 11th November 2011
Page Count: 638
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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.

Key Features

  • Provides extensive coverage of the "study schema" and related features of study design
  • Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design
  • Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design
  • Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials
  • Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe


For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser:


Pharmaceutical scientists and pharmacologists, medical writers and physicians, nurses and pharmacists who plan and conduct clinical trials.

Table of Contents





Abbreviations and Definitions


Chapter 1. The Origins of Drugs

I. Introduction

II. Structures of drugs

III. The 20 classical amino acids

IV. Animal models

Chapter 2. Introduction to Regulated Clinical Trials

I. Introduction

II. Study design

III. The study schema

IV. Further concepts in study design

V. Summary

VI. Amendments to the clinical study protocol

Chapter 3. Run-in Period

I. Introduction

II. Concluding remarks

Chapter 4. Inclusion/Exclusion Criteria, Stratification, and Subgroups – Part I

I. The clinical study protocol is a manual that provides the study design

II. Biology of drug resistance

III. More information on subgroups

IV. Concluding remarks

Chapter 5. Inclusion and Stratification Criteria – Part II

I. Introduction

II. Staging

III. Staging systems for various cancers

IV. Summary

V. The will rogers phenomenon

VI. Other sources of artifacts in data from clinical trials

VII. Concluding remarks

Chapter 6. Randomization, Allocation, and Blinding

I. Introduction

II. Manual technique for allocation

III. Information on randomization, blinding, and unblinding may be included in the clinical study protocol

IV. Summary

V. Subjects are enrolled into clinical trials, one by one, over the course of many months

VI. Blocked randomization

VII. Blinding

VIII. Interactive voice response systems

IX. Concluding remarks

Chapter 7. Placebo Arm as Part of Clinical Study Design

I. Introduction

II. Hawthorne effect

III. The no-treatment arm

IV. Physical aspects of the placebo

V. Active placebo


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Academic Press
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About the Author

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.


"A solid guide to designing clinical trials for medical scientists, especially those working in oncology, immune disease, and infectious disease…Three chapters address quality-of-life topics."  -Selected for The First Clinical Research Bookshelf, "Essential Reading for Clinical Research Professionals," Journal of Clinical Research Best Practices, September 2012, Vol. 8, No. 9