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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines, by Tom Brody PhD
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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
- Sales Rank: #1181673 in Books
- Published on: 2011-11-25
- Original language: English
- Dimensions: 9.50" h x 7.75" w x 1.50" l, 3.17 pounds
- Binding: Hardcover
- 638 pages
Review
"…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
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 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.
Most helpful customer reviews
3 of 3 people found the following review helpful.
Comprehensive and well organized. Highly recommended.
By Mara Gil
This is the most comprehensive book on clinical trials I've seen so far.
Touches all key areas of clinical trials conduct; I very much enjoyed (yes, I do enjoy learning about the work I love!) the elaboration on Biomarkers and Endpoints. This manual is useful even for experienced professionals, has chapters to be used as a reference and presents new information as well. Extremely well organized, easy to read and informative, a must for any clinical research professional.
4 of 6 people found the following review helpful.
Quoted from a review originally published in, "Journal of Clinical Research Best Practices" Vol. 8, Sept. 2012
By Tom Brody
The following is a quotation from a review that was published in Journal of Clinical Research Best Practices, Vol. 8, Sept. 2012. The author of this review is Norman M. Goldfarb.
The published review is as follows, and I quote:
"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. 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."
[My comment on the above writing is that the chapter on STATISTICS contains seventeen (17) mathematical formulas.]
The published review by Dr. Goldfarb also states, "Essential reading for clinical research professionals."
The published review also reveals this:
"The section on study designs discusses and provides diagrams for 17 schemas. The following text illustrates the book's fairly technical style:
FORWARDS SEQUENCE AND REVERSE SEQUENCE -- THE PUHALLA SCHEMA.
The clinical trial of Puhalla et al. (38) contains two arms (Fig. 2.8). Subjects in the first arm received drugs in this order: D followed by AC. In detail, subjects received docetaxel on the first day of each cycle, for 4 cycles, where each cycle was 14 days long. This was followed by doxorubicin (an anthracycline drug) plus cyclophosphamide, on the first day of each cycle, for 4 cycles. Each cycle was 2 weeks long.
Now, this is about the second arm. Subjects in the second arm received drugs in the reverse order, that is, AC followed by D. The investigators chose a 2-arm study design, where each arm was the reverse of the other, because it was not possible to predict which order would provide the better outcome.
The type of trial design, where one arm uses a "forward sequence" of two drugs, and where another arm uses the "reverse sequence" of the two drugs, sometimes finds a basis in the mechanism of action of certain drugs. The following specifically concerns chemotherapy involving paclitaxel and gemcitabine. As explained by Paccagnella et al. (39) for a clinical trial on lung cancer, "[s]everal reports have shown that the sequence of administration of gemcitabine and paclitaxel may also affect the efficacy of this combination chemotherapy, since paclitaxel increases the concentration of active metabolite of gemcitabine (dFdCTP) when administered first."
To repeat, the above review was written by Norman M. Goldfarb. The complete version of Dr. Goldfarb's review was published in J. Clin. Res. Best Practices, Vol. 8, Sept. 2012.
1 of 3 people found the following review helpful.
Received my book.
By susan hmwe
Hi,
I have received my book. I will recommend this book to anyone who just enters clinical trial industry. Thank you!
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