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.

FEATURES:

• 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

Contents

Chapter One: A Brief History of Clinical Trials, Drug Regulations,and the Food and Drug Administration
Chapter Two: Information Technology, Access, ClinicalTrials.gov
Chapter Three: The Role of Academic Research Organizations in Clinical Research
Chapter Four: Ethics of Clinical Research: An Overview and Emerging Issues
Chapter Five: Introduction to Clinical Experimentation
Chapter Six: PhaseI Trials: First in Human
Chapter Seven: Phase II Clinical Trials
Chapter Eight: Phase III and IV Clinical Trials
Chapter Nine: Challenges of Clinical Trials in Pediatrics
Chapter Ten: Observational Research
Chapter Eleven: Data Resources
Chapter Twelve: Observational Study Designs
Chapter Thirteen: Challenges of Observational Designs
Chapter Fourteen: Specific Regression Techniques
Chapter Fifteen: Analytical Methods of Addressing Confounding
Chapter Sixteen: Lessons from Notable Examples in Observational Research