Clinical Trials

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

Tom Brody

• Publisher: Academic Press
• Year: 2011
• eBook ISBN:
  9780123919137
• Topic: Medicina
• Subtopic: Medicina clinica

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. - 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: http://tinyurl.com/awwutvn

Table of contents

• Cover image
• Table of Contents
• Front-matter
• Copyright
• Dedication
• Acknowledgments
• Preface
• Introduction
• Abbreviations and Definitions
• Biography
• Chapter 1. The Origins of Drugs
• Chapter 2. Introduction to Regulated Clinical Trials
• Chapter 3. Run-in Period
• Chapter 4. Inclusion/Exclusion Criteria, Stratification, and Subgroups – Part I
• Chapter 5. Inclusion and Stratification Criteria – Part II
• Chapter 6. Randomization, Allocation, and Blinding
• Chapter 7. Placebo Arm as Part of Clinical Study Design
• Chapter 8. Intent to Treat Analysis vs. Per Protocol Analysis
• Chapter 9. Biostatistics
• Chapter 10. Introduction to Endpoints for Clinical Trials in Pharmacology
• Chapter 11. Endpoints in Clinical Trials on Solid Tumors – Objective Response
• Chapter 12. Oncology Endpoints
• Chapter 13. Oncology Endpoints
• Chapter 14. Oncology Endpoint
• Chapter 15. Oncology Endpoint
• Chapter 16. Neoadjuvant Therapy versus Adjuvant Therapy
• Chapter 17. Hematological Cancers
• Chapter 18. Biomarkers and Personalized Medicine
• Chapter 19. Endpoints in Immune Diseases
• Chapter 20. Endpoints in Clinical Trials on Infections
• Chapter 21. Health-Related Quality of Life
• Chapter 22. Health-Related Quality of Life Instruments for Immune Disorders
• Chapter 23. Health-Related Quality of Life Instruments and Infections
• Chapter 24. Drug Safety
• Chapter 25. Mechanism of Action, Part I
• Chapter 26. Mechanisms of Action, Part II – Cancer
• Chapter 27. Mechanisms of Action, Part III – Immune Disorders
• Chapter 28. Mechanisms of Action, Part IV – Infections
• Chapter 29. Consent Forms
• Chapter 30. Package Inserts
• Chapter 31. Regulatory Approval
• Chapter 32. Patents
• Index