Fundamentals of Clinical Trials

Rating:
Summary: Generalized review
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.

Rating:
Summary: Good intro textbook
Review: 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.

Rating:
Summary: CONCISE MULTIDISCIPLINARY APPROACH
Review: 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.

Rating:
Summary: A great introduction to clinical trials
Review: This book is a very good place to start for those who want to learn about the design and analysis of clinical trials. However there is a heavy emphasis on statistics - a basic knowledge of stats is essential.