Designing Clinical Research Paperback – July 2, 2013 Author: Dr. Stephen B Hulley MD MPH | Language: English | ISBN:
1608318044 | Format: PDF, EPUB
Designing Clinical Research – July 2, 2013
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- Paperback: 378 pages
- Publisher: LWW; Fourth edition (July 2, 2013)
- Language: English
- ISBN-10: 1608318044
- ISBN-13: 978-1608318049
- Product Dimensions: 10 x 7.1 x 0.5 inches
- Shipping Weight: 1.4 pounds (View shipping rates and policies)
- Amazon Best Sellers Rank: #7,995 in Books (See Top 100 in Books)
- #3 in Books > Textbooks > Medicine & Health Sciences > Administration & Policy > Public Health
- #5 in Books > Textbooks > Medicine & Health Sciences > Research
- #7 in Books > Medical Books > Administration & Medicine Economics > Public Health
Clinical Trials have evolved over the past few decades in multiple dimensions. There are legal, regulatory, statistical, procedural, and clinical dimensions which tend to structure them in ways which were not prevalent to anyone who entered medicine decades earlier. The book by Hulley et al, Designing Clinical Research, is a wonderful overview of most of these dimensions. It brings the reader up to date with many of the key factors which have become part of Trials and give an excellent amount of depth so that the book stands on its own.
The book is divided into three major sections; (i) Basics including sampling, trial hypotheses testing and statistical analyses as well and general trial types. (ii) Designs which examines the various types of trials from randomized case control, cross-sectional, and other such classic trial methodologies, (iii) Implementation, including the ethical issues and data management.
The Basics provides a reasonable overview of the randomization, sizing, and the establishment of the statistical plan for a Trial. The approach is classic with the null hypothesis approach and the metrics necessary for properly sizing a successful Trial. The presentation is in a summary nature and the reader is either expected to be familiar with the development of the mathematics or just to use the Tabular approaches as presented. There are excellent discussions on various approaches such as continuous versus dichotomous and the material is useful even for those well experienced in the area.
The Designing sections go over the details associated with various Trial approaches and discuss the implementation, and the advantages and disadvantages. Again, even for someone already familiar with the material the authors provide added insight well worth the reading.
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