Guide to Clinical Trials [Hardcover]

Bert Spilker (Author)

Book Description

Publication Date: January 15, 1991 | ISBN-10: 0881677671 | ISBN-13: 978-0881677676 | Edition: 1st

Guide to Clinical Trials is the definitive text and reference that sets the standard in contemporary clinical trial methodology. More than 130 chapters grouped into twelve sections take the reader step by step through every phase of a clinical trial--from planning trials and writing protocols to analyzing data, publishing results, and evaluating published literature. Dr. Spilker's approach is uniquely practical, addressing problems of study design and data interpretation from a clinical, nonmathematical perspective. Another particularly helpful feature of the book is an extensive collection of tables, figures, and checklists.

Editorial Reviews

Review

Lancet -- "An encyclopedic overview of the important steps in the planning, execution, and interpretation of clinical trials.^.^.^.Spilker's methodical and non-partisan handling of the many controversies in design and analysis make it highly readable for anyone involved in clinical research." --Lancet Journal of Medicinal Chemistry -- "[This volume] clearly represents the definitive work on the topic.^.^.^.[This is a] monumental work. It is a superb reference source for active participants in clinical research." --Journal of Medicinal Chemistry New England Journal of Medicine -- "This book is a formidable collection of practical information...There is a good deal of valuable information here." --New England Journal of Medicine

Product Details

• Hardcover: 1156 pages
• Publisher: Lippincott Williams & Wilkins; 1st edition (January 15, 1991)
• Language: English
• ISBN-10: 0881677671
• ISBN-13: 978-0881677676
• Product Dimensions: 11.4 x 8.7 x 2.4 inches
• Shipping Weight: 6.6 pounds
• Average Customer Review: 4.2 out of 5 stars  See all reviews (4 customer reviews)
• Amazon Best Sellers Rank: #1,589,948 in Books (See Top 100 in Books)

More About the Author

Discover books, learn about writers, read author blogs, and more.

Customer Reviews

Most Helpful Customer Reviews

13 of 14 people found the following review helpful:

2.0 out of 5 stars Mediocre book - full of fluff, September 22, 1999

By A Customer

This review is from: Guide to Clinical Trials (Hardcover)

This is a decent book, but packed with padding. You have to read 50 pages to get 1 page worth of useful information. Spilker is adequately familiar with clinical trials, but his writing style tends to meander a lot.

If you're a complete novice, it may be of use, but you will outgrow it after a few months. And unfortunately, the book is somewhat outdated--clinical trials are much more sophisticated now. I'm not sure what the person below is talking about--using it after 30 years in the industry!?! Anyone who's been in the industry for more than couple of years should know everything there is in this book.

6 of 7 people found the following review helpful:

5.0 out of 5 stars Good reference for Start-up Companies, April 2, 2003

By A Customer

This review is from: Guide to Clinical Trials (Hardcover)

Working in a small biotech start-up company, I think this book is a great reference especially if you have limited resources and interested in conducting drug development the "right" way. This text covers all areas of drug development and useful for people in regulatory affairs, project management, clinical affairs, and data management.

4 of 5 people found the following review helpful:

5.0 out of 5 stars The best guideline book on the subject., October 15, 1998

By A Customer

This review is from: Guide to Clinical Trials (Hardcover)

A basic handbook for management of clinical trials. This is a "must" reading for anyone who deals with clinical trials. It covers areas of protocol development, regulatory issues in human clinical trials. There is a detailed section on data collection, handling data and statistical issues.Also an introduction to project management.The book contains a large amount of tables easy to read and with great "tips".