Principles and Practice of Clinical Trial Medicine

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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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Product Details

  • ISBN-13: 9780123736956
  • Publisher: Elsevier Science
  • Publication date: 7/2/2008
  • Edition description: New Edition
  • Pages: 560
  • Product dimensions: 8.70 (w) x 10.90 (h) x 1.20 (d)

Meet 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.

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Table of Contents

Sect. I Overview 1

Ch. 1 Overview of clinical research medicine 3

Ch. 2 Ethical, legal, and regulatory issues 17

Sect. II The general structure of clinical trials and programs 41

Ch. 3 Introduction to clinical trial statistics 43

Ch. 4 Measure and variables 61

Ch. 5 Study groups 79

Ch. 6 Periods, sequences, and trial design 95

Sect. III Key components of clinical trials and programs 119

Ch. 7 Endpoints 121

Ch. 8 Economics and patient reported outcomes 145

Ch. 9 Patient selection and sampling 167

Ch. 10 Dosing and intervention 181

Ch. 11 Epidemiology, decision analysis, and simulation 213

Sect. IV Conduct of the study 231

Ch. 12 Study execution 233

Ch. 13 Site selection and patient recruitment 283

Sect. V Analysis of results 301

Ch. 14 Assessing data quality and transforming data 303

Ch. 15 Analysis of data 325

Ch. 16 Data interpretation and conclusions 361

App. A FDA internal compliance manuals 389

App. B Medwatch form 409

App. C FDA reviewer guidance on safety review 411

App. D Common terminology criteria for adverse events (CTCAE) 461

App. E Sample investigational new drug application form 535

App. F Statement of investigator form 1572 537

Index 539

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Customer Reviews

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Sort by: Showing all of 2 Customer Reviews
  • Anonymous

    Posted July 10, 2008

    A reviewer

    This book is very easy and entertaining to read. It has numerous examples and explains concepts in a very clear manner. You end up learning the material very easily. This is a great book to read if you are interested in working for the pharmaceutical, biotech, or medical device industries or if you want to do research in a university. There aren't too many other books that cover all of this subject matter and most of them are hard to read.

    1 out of 1 people found this review helpful.

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  • Posted April 26, 2009

    Very Comprehensive

    I found this book to be very comprehensive and up to date, much more so than some of the other books that are available.

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