Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines [Kindle Edition]
Author: Tom Brody | Language: English | ISBN: B006CFZSEU | Format: PDF, EPUB
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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
Books with free ebook downloads available Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines- File Size: 2968 KB
- Print Length: 672 pages
- Publisher: Academic Press; 1 edition (October 25, 2011)
- Sold by: Amazon Digital Services, Inc.
- Language: English
- ASIN: B006CFZSEU
- Text-to-Speech: Enabled
- Lending: Not Enabled
- Amazon Best Sellers Rank: #672,011 Paid in Kindle Store (See Top 100 Paid in Kindle Store)
- #65 in Books > Medical Books > Pharmacology > Clinical
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.
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