Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines, 2nd Edition

  • Tom Brody
  • Published By:
  • ISBN-10: 0128042583
  • ISBN-13: 9780128042588
  • DDC: 610.724
  • Grade Level Range: College Freshman - College Senior
  • 896 Pages | eBook
  • Original Copyright 2016 | Published/Released August 2016
  • This publication's content originally published in print form: 2016

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This practical guide takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects 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.

Table of Contents

Front Cover.
Half Title Page.
Title Page.
Copyright Page.
Abbreviations and Definitions.
1: Origins of Drugs.
2: Clinical Trial Design.
3: Run-in Period.
4: Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part I.
5: Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part II.
6: Blinding, Randomization, and Allocation.
7: Placebo Arm as Part of Clinical Trial Design.
8: Intent-to-Treat Analysis Versus Per Protocol Analysis.
9: Biostatistics—Part I.
10: Biostatistics—Part II.
11: Introduction to Endpoints.
12: Oncology Endpoint—Objective Response.
13: Oncology Endpoints: Overall Survival and Progression-Free Survival.
14: Oncology Endpoints: Time to Progression.
15: Oncology Endpoint: Disease-Free Survival.
16: Oncology Endpoint: Time to Distant Metastasis.
17: Neoadjuvant Therapy Versus Adjuvant Therapy.
18: Hematological Cancers.
19: Biomarkers.
20: Endpoints for Immune Diseases.
21: Endpoints for Infections.
22: Health-Related Quality of Life Tools—Oncology.
23: Health-Related Quality-of-Life Tools—Immune Disorders.
24: Health-Related Quality-of-Life Tools—Infections.
25: Drug Safety.
26: Mechanism of Action of Diseases and Drugs—Part I.
27: Mechanism of Action—Part II (Cancer).
28: Mechanism of Action—Part III (Immune Disorders).
29: Mechanisms of Action—Part IV (Infections).
30: Consent Forms.
31: Package Inserts.
32: Warning Letters.
33: Regulatory Approval.
34: Patents.