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Rating: 
Summary: The best guideline book on the subject.
Review: 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".
Rating:
Summary: This text is the industry standard.
Review: If you could only have one book on clinical research, this should be the one. It is comprehensive, and presents much of the material in tabular format that greatly facilitates learning. I have been in the drug development business for over 30 years and still refer to this text on a regular basis.
Rating: 
Summary: Mediocre book - full of fluff
Review: 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 And unfortunately, the book is somewhat outdated--clinical trials are much more sophisticated now.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.
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Summary: Good reference for Start-up Companies
Review: 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.
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