Fundamentals of Clinical Trials 4th ed. 2010 Edition

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ISBN-13: 978-1441915856
ISBN-10: 1441915850
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Editorial Reviews

Review

From the reviews of the fourth edition:

“This book is clearly written for students in the arena of health care. Physicians and health care providers can use it as a reference book. … The organization and structure is good and logical. … it deepens the understanding of applications of statistical methods and the analysis of clinical trials. Also, it provides a list of references at the end of each chapter. … In summary, this is an important contribution, providing up-to-date coverage on clinical trial methodology in a logical and systematic manner.” (Technometrics, Vol. 53 (2), May, 2011)

From the Back Cover

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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Product Details

  • Paperback: 445 pages
  • Publisher: Springer; 4th ed. 2010 edition (September 21, 2010)
  • Language: English
  • ISBN-10: 1441915850
  • ISBN-13: 978-1441915856
  • Product Dimensions: 6.1 x 1 x 9.2 inches
  • Shipping Weight: 1.5 pounds (View shipping rates and policies)
  • Average Customer Review: 4.8 out of 5 stars  See all reviews (12 customer reviews)
  • Amazon Best Sellers Rank: #68,909 in Books (See Top 100 in Books)

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Most Helpful Customer Reviews

4 of 4 people found the following review helpful By Deepak Parakkal on February 21, 2013
Format: Paperback Verified Purchase
Used this with my course on clinical research methods. Very exhaustive description of the details of clinical trial design, implementation, analysis and reporting. Recommended for any clinical researcher conducting or wanting to improve their knowledge of clinical trials.
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3 of 3 people found the following review helpful By Patrick J. Toppin on January 18, 2014
Format: Kindle Edition Verified Purchase
I found this book very easy to read and it gave many real life examples. I started with basically no experience or knowledge of the subject matter. I think it was an excellent introduction to the topic.
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3 of 3 people found the following review helpful By biermam on March 12, 2013
Format: Kindle Edition
I attended Lawrence Friedman's course in clinical trial management at the Münster Epidemiology Summer school in two successive years because it was so good. The book is even better.
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2 of 3 people found the following review helpful By Amazon Customer on May 4, 2013
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Lawrence Friedman is one of the world's leading authorities on clinical trials management. I have been using this book for years.
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By Christopher Anderson on November 9, 2014
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Very useful text for those interested in being involved in clinical research. A bit dry
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By kingking on April 21, 2015
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The price tells everything. Not perfectly printed, but worth the price!
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