Fundamentals of Clinical Trials

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This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The text uses numerous examples of published clinical trials from a variety of medical disciplines to meaningfully illustrate the fundamentals. Technical design issues ...
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Overview

This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The text uses numerous examples of published clinical trials from a variety of medical disciplines to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered, but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity.

The book contains black-and-white illustrations.

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Editorial Reviews

Bernard J. Turnock
This book presents fundamental concepts and activitiesassociated with the design and implementation of clinical researchtrials. In biomedical research, clinical trials have emerged as one ofthe most important and commonly used research designs. This bookseeks to serve both as a guide and resource for investigators involvedin clinical trials both in academic and industrial settings. It hitsthe mark on both accounts. Although the primary audience is clearlymany different categories of health professionals involved in activeresearch, this book's topics and straightforward style will also appealto students and clinicians as well. The basic concepts andapplications are presented in a manner that clearly explains therationale and key steps of the research process. As a result, thisbook facilitates understanding and appreciation of clinical trialsamong noninvestigators even while it guides and assists the efforts ofexperienced researchers. The authors all have extensive experience inthe subject matter; this volume is their third edition and has beenupdated substantially. This is a very solid addition to theliterature and a title that is likely to be read and appreciated bymany different categories of health professionals. This will be veryuseful to most health science libraries.
From The Critics
Reviewer: Bernard J. Turnock, MD, MPH (University of Illinois at Chicago)
Description: This book presents fundamental concepts and activities associated with the design and implementation of clinical research trials. In biomedical research, clinical trials have emerged as one of the most important and commonly used research designs.
Purpose: This book seeks to serve both as a guide and resource for investigators involved in clinical trials both in academic and industrial settings. It hits the mark on both accounts.
Audience: Although the primary audience is clearly many different categories of health professionals involved in active research, this book's topics and straightforward style will also appeal to students and clinicians as well.
Features: The basic concepts and applications are presented in a manner that clearly explains the rationale and key steps of the research process. As a result, this book facilitates understanding and appreciation of clinical trials among noninvestigators even while it guides and assists the efforts of experienced researchers. The authors all have extensive experience in the subject matter; this volume is their third edition and has been updated substantially.
Assessment: This is a very solid addition to the literature and a title that is likely to be read and appreciated by many different categories of health professionals. This will be very useful to most health science libraries.

3 Stars from Doody
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Product Details

  • ISBN-13: 9780884164999
  • Publisher: Mosby, Incorporated
  • Publication date: 1/1/1996
  • Edition description: 3rd ed
  • Edition number: 2
  • Pages: 320

Table of Contents

1 Introduction to Clinical Trials 1
2 What Is the Question? 16
3 Study Population 30
4 Basic Study Design 41
5 The Randomization Process 61
6 Blindness 82
7 Sample Size 94
8 Baseline Assessment 130
9 Recruitment of Study Participants 140
10 Data Collection and Quality Control 156
11 Assessing and Reporting Adverse Effects 170
12 Assessment of Health-Related Quality of Life 185
13 Participant Adherence 204
14 Survival Analysis 223
15 Monitoring Response Variables 246
16 Issues in Data Analysis 284
17 Closeout 323
18 Reporting and Interpreting of Results 333
19 Multicenter Trials 345
Index 357
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