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
Dimensions:
Width: 19.70cm
, Height: 3.80cm
, Length: 24.00cm
Weight: 1.540kg
ISBN: 9780123919113
ISBN 10: 0123919118
Pages: 638
Publication Date: 24 November 2011
Audience:
Professional and scholarly
,
Professional & Vocational
Replaced By: 9780128042175
Format: Hardback
Publisher's Status: Out of Print
Availability: Awaiting stock
Reviews
.a solid guide to?designing clinical trials for medical?scientists, especially those working in oncology, immune disease, and infectious disease. The statistical chapters are brief?and include very few formulae. Three chapters address quality-of-life topics. In addition to the core material, the book also includes chapters on some ancillary topics like patents and package inserts. Because the book is not about trial conduct, it does not focus on topics like regulatory compliance, human subjects protection, or case report forms. --Journal of Clinical Research Best Practices, September 2012, Vol. 8, No. 9
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a solid guide to designing clinical trials for medical scientists, especially those working in oncology, immune disease, and infectious disease. -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 Ph.D. from the University of California at Berkeley in 1980 and has published several research articles in the areas of enzymology, metabolism and pharmacokinetics of folates and related amino acids. For his post-doctoral work, also at U.C. Berkeley, the author cloned, sequenced, and expressed an oncogene, and purified the encoded protein (xeroderma pigmentosum E; XPE). The XPE gene encodes a DNA repair protein. Later, he performed research on the structure of an antibody (natalizumab) used for treating multiple sclerosis. At an earlier time, he wrote two editions of Nutritional Biochemistry, published by Elsevier, Inc. The author is a registered patent agent.
