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Principles and Practice of Clinical Trial Medicine
 
 
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Principles and Practice of Clinical Trial Medicine [Hardcover]

Richard Chin (Author), Bruce Y Lee (Author)
5.0 out of 5 stars  See all reviews (4 customer reviews)

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Book Description

0123736951 978-0123736956 July 2, 2008 1
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

*Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data.

*Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine.

*Expert authorship whose experience includes running clinical trials in an academic as well as industry settings.

*Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy.

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Principles and Practice of Clinical Trial Medicine + Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators + A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
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Editorial Reviews

About the Author

Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar.

Dr. Lee is currently an Assistant Professor of Medicine and Biomedical Informatics at the University of Pittsburgh. He is also Core Faculty in the Section for Decision Sciences and Clinical Systems Modeling, the Center for Research in Health Care, and the RAND-University of Pittsburgh Health Institute. He is a Co-Investigator for the National Institutes of Health (NIH) Modeling of Infectious Diseases Agent Study (MIDAS) research and informatics network. His previous positions include serving as Senior Manager at Quintiles Transnational, working in biotechnology equity research at Montgomery Securities, and co-founding Integrigen, a biotechnology company. His consulting experience includes a large variety of clients, ranging from large and small pharmaceutical, biotechnology, and medical device companies. Dr. Lee has authored three books, as well as numerous research publications, review articles, and book chapters. Dr. Lee received his B.A. from Harvard University, M.D. from Harvard Medical School, and M.B.A. from the Stanford Graduate School of Business. He is board-certified in Internal Medicine, having completed his residency training at the University of California, San Diego.


Product Details

  • Hardcover: 560 pages
  • Publisher: Academic Press; 1 edition (July 2, 2008)
  • Language: English
  • ISBN-10: 0123736951
  • ISBN-13: 978-0123736956
  • Product Dimensions: 10.9 x 8.5 x 1.1 inches
  • Shipping Weight: 3.2 pounds (View shipping rates and policies)
  • Average Customer Review: 5.0 out of 5 stars  See all reviews (4 customer reviews)
  • Amazon Best Sellers Rank: #1,103,382 in Books (See Top 100 in Books)

 

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6 of 6 people found the following review helpful:
5.0 out of 5 stars A great book, April 13, 2009
This review is from: Principles and Practice of Clinical Trial Medicine (Hardcover)
This is a really well written, comprehensive book. It covers just about anything you'd want to know about clinical studies. It will teach you a lot even if you've been doing clinical research for a while, it's very sophisticated. But not too many equations, although it has a few. You will probably find it very accessible even if you're new to clinical research.
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2 of 2 people found the following review helpful:
5.0 out of 5 stars Excellent text for learning all levels of CTM, June 13, 2011
This review is from: Principles and Practice of Clinical Trial Medicine (Hardcover)
As a newcomer to the pharma industry, this text is a must have to learn about clinical trials medicine through its early stages of development to advanced standards of clincal trial methodology. The text is easy to read and clearly guides the reader to understand all clinical trial components and processes. Perfect for students and industry persons alike, I highly recommend this book if you need to gain a thorough understanding of clinical trials research, from the basics of definition through comprehensive clinical trial analysis.
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1 of 1 people found the following review helpful:
5.0 out of 5 stars The kind of book I wish I had this book when I started, June 19, 2011
This review is from: Principles and Practice of Clinical Trial Medicine (Hardcover)
I read this book because I was impressed by another book, Global Clinical Trials, which was edited by one of the authors.

This is a pretty nice book that does a great job of covering a very wide range of fundamental topics that anyone doing clinical trials ought to know. It would have been great to have had this book when I started in industry.
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Inside This Book (learn more)
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
different study arms, dash analogy, protocol waivers, multiple primary endpoints, descriptive trials, two study arms, congestive heart failure exacerbations, single primary endpoint, major protocol violations, protect patient safety, study treatment group, next coin flip, assessing data quality, audit host, hierarchical testing, one primary endpoint, responder analysis, overall patient population, safety endpoints, group sequential design, good endpoint, statistical analysis plan, investigational product, patient dropouts, completer analysis
Key Phrases - Capitalized Phrases (CAPs): (learn more)
Study Arm, Analysis of Results, United States, Conduct of the Study, European Union, Analysis of Data, African Americans, Decision Analysis, Clinical Trial Statistics, Asian Americans, General Assembly, New York City, Placebo Active, Overview of Clinical Research Medicine, International Conference, Liver Rejectase, Declaration of Helsinki, San Diego, Nuremberg Code, San Francisco, Gold Standard, Hong Kong, Belmont Report, Simpson's Paradox, Privacy Rule
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Front Cover | Table of Contents | First Pages | Index | Surprise Me!
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