Overview
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.
Full Product Details
Author: Tom Brody (Contract Researcher, Baker Hostetler, San Francisco, CA, USA)
Publisher: Elsevier Science Publishing Co Inc
Imprint: Academic Press Inc
Weight: 1.820kg
ISBN: 9780128102572
ISBN 10: 0128102578
Pages: 638
Publication Date: 13 January 2017
Audience:
Professional and scholarly
,
Professional & Vocational
Format: Paperback
Publisher's Status: Active
Availability: Not yet available
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.
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
...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
Author Information
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.
