Understanding Clinical Research / Edition 1

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Overview

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
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Editorial Reviews

Doody's Review Service
Reviewer: Vincent F Carr, DO, MSA, FACC, FACP (Uniformed Services University of the Health Sciences)
Description: This book details the history of how clinical research studies began in the U.S. and explains phase I through IV clinical trials, observational research, and regression techniques.
Purpose: The purpose is to demonstrate the importance of observational clinical research and to reinforce that there is a valid place for this kind of research even in these times of emphasis on the classic, double-blind, large, multicenter, and longitudinal research studies. The authors and contributors are highly experienced clinicians and researchers.
Audience: The book is designed to help younger researchers who have difficulty obtaining funding for their studies recognize that there are still opportunities to become published with observational research.
Features: It begins with the advances and the problems with early research studies and how many of the ethical considerations have developed. For young researchers, this is extremely valuable material. The second section, "Principles of Clinical Experimentation," outlines the different phases of clinical trials with a great deal of practical information on phase III and IV clinical trials. One of the nicer aspects of the book is the way it presents specific sketches of how valuable information has been gained in these phase III and IV studies. Another is the way this book differs from other research books that focus on the statistics or the history. This is a very practical book.
Assessment: What makes this book on research stand out is the focus on observational studies as a way to develop experience in research at a time when funding for larger double-blind studies is difficult to get.
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Product Details

  • ISBN-13: 9780071746786
  • Publisher: McGraw-Hill Professional Publishing
  • Publication date: 6/14/2013
  • Series: Understanding Series
  • Edition number: 1
  • Pages: 272
  • Sales rank: 1,375,710
  • Product dimensions: 5.90 (w) x 8.90 (h) x 0.70 (d)

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