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

by Tom Brody PhD

Overview

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. - 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

Product Details

ISBN-13:	9780128042588
Publisher:	Elsevier Science & Technology Books
Publication date:	02/19/2016
Sold by:	Barnes & Noble
Format:	eBook
Pages:	896
File size:	9 MB

About the Author

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.

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

What People are Saying About This

From the Publisher

A hands-on guidebook that integrates the most practical aspects of clinical trial design with important content on laboratory studies of human data, patient safety, regulatory requirements and much more

Editorial Reviews

"…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

From the Publisher