Product Description

This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The text uses numerous examples of published clinical trials from a variety of medical disciplines to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered, but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity.

Product Details

• Amazon Sales Rank: #20131 in Books
• Published on: 1999-12
• Original language: English
• Number of items: 1
• Binding: Paperback
• 361 pages

Features

• ISBN13: 9780387985862
• Condition: NEW
• Notes: Brand New from Publisher. No Remainder Mark.
• Click here to view our Condition Guide and Shipping Prices

Customer Reviews

Good intro textbook
I used this book for a class that I took last semester on clinical trial.

The authors do a good job of giving a good overview of the topics of interest, in particular: sample size calculation, use of DSMBs, trial design, choice of endpoints, randomization and issues in data analysis.

The chapters on sample size estimation and use of safety monitoring boards are quite heavy on the statistics. If you've never had an intro class in statistics, then these chapters may be way over your head.

There are a few topics that the authors didn't cover so well that I thought should have been more prominent: Choice of primary endpoints in FDA trials, general requirements of the FDA and regulatory information in general, the calculations of meta-analyses.

Overall I am quite happy with this book and will keep it on my shelf as a good reference.

Generalized review
Friedman et al have done a commendable job of explaining the entire clinical trial process. The monograph is complete as to the requirements of the undertaking and adequate resource is devoted to serveral of the more problematic areas such as sample size estimation and the establishment of baseline characteristics.

CONCISE MULTIDISCIPLINARY APPROACH
The fact that this book was designed for researchers, who are involved in experimental (clinical) trials, makes the basic knowledge of statistics essential.
Using an interactive multidisciplinary approach to investigation, this handbook embraced all aspects clinical and paraclinical survey. It is very easy-to-follow, and divulges its methodology in concise manner. "Fundamentals of Clinical Trials" is one book that will help alleviate the rigorous chores of epidemiologists. However, an advanced or versatile researcher may complain that some of the information in it are too summarized.