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Fundamentals of Clinical Trials 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.

Fundamentals of Clinical Trials Overview

This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis.This book 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 authors use numerous examples of published clinical trials from a variety of medical disciplines to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives.Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology.

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