Clinical Trials

1st Edition

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

Print ISBN: 9780128102572
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.

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 2012
Academic Press
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"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