Understanding Clinical Research / Edition 1

Understanding Clinical Research / Edition 1

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McGraw-Hill Education
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Understanding Clinical Research / Edition 1

A complete guide to understanding and applying clinical research results

Ideal for both researchers and healthcare providers

Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials—from study design and statistics to regulatory oversight—and it delivers a detailed yet streamlined overview of must-know research topics.

The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples—drawn from the authors' broad experience—that put chapter concepts into action and contribute to a working knowledge of integral research techniques.


  • The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes
  • In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education
  • Clear, comprehensive three-part organization:
    • Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations
    • Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products,
      from initial human subject research to postapproval surveillance studies
    • Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials

Product Details

ISBN-13: 9780071746786
Publisher: McGraw-Hill Education
Publication date: 06/14/2013
Series: Understanding Series
Edition description: New Edition
Pages: 272
Sales rank: 652,843
Product dimensions: 5.90(w) x 8.90(h) x 0.70(d)

Table of Contents

Contributors ix

Foreword xiii

Preface xv

Section I Evolution of Clinical Research Renato D. Lopes

Chapter 1 A Brief History of Clinical Trials, Drug Regulations, and the Food and Drug Administration Nidhi Tripathi Kate Davis Catherine Bodine Daniel K. Benjamin Jr. 3

Chapter 2 Information Technology, Access, ClinicalTrials.gov Anjan K. Chakrabarti C. Michael Gibson 17

Chapter 3 The Role of Academic Research Organizations in Clinical Research Craig J. Reist Tyrus L. Rorick Lisa G. Berdan Renato D. Lopes 27

Chapter 4 Ethics of Clinical Research: An Overview and Emerging Issues Yee Weng Wong Kevin A. Schulman 39

Section II Principles of Clinical Experimentation Daniel K. Benjamin Jr. Karen S. Pieper

Chapter 5 Introduction to Clinical Experimentation Robert Bigelow 65

Chapter 6 Phase I Trials: First in Human Kevin M. Watt Karen Chiswell Michael Cohen-Wolkowiez 83

Chapter 7 Phase II Clinical Trials Jeffrey T. Guptill Karen Chiswell 101

Chapter 8 Phase III and IV Clinical Trials Gail E. Hafley Sergio Leonardi Karen S. Pieper 113

Chapter 9 Challenges of Clinical Trials in Pediatrics Kevin N. Turner P. Brian Smith 127

Section III Observational Research Lesley H. Curtis Laine E. Thomas

Chapter 10 Observational Research Michaela A. Dinan 143

Chapter 11 Data Resources Ying Xian 157

Chapter 12 Observational Study Designs Bradley G. Hammill 169

Chapter 13 Challenges of Observational Designs David M. Vock 179

Chapter 14 Specific Regression Techniques Phillip J. Schulte Laine E. Thomas 189

Chapter 15 Analytical Methods of Addressing Confounding Eric M. Reyes Laine E. Thomas 209

Chapter 16 Lessons from Notable Examples in Observational Research Zubin J. Eapen 227

Index 237

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