Overview
- Authors:
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Frank L. Iber
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Hines Veterans Administration Medical Center and Loyola University Stritch School of Medicine, Mayfield, USA
University of Maryland School of Medicine, Baltimore, USA
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W. Anthony Riley
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Baltimore Medical System, Inc., Baltimore, USA
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Patricia J. Murray
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Boston, USA
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Table of contents (29 chapters)
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Introduction
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 3-17
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Entering the Field of Clinical Trials
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 21-28
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 29-41
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 43-50
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 51-66
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 67-76
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 77-81
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The Institutional Review Mechanism
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 85-103
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The Recruitment Process
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Front Matter
Pages 105-105
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 107-125
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Critical Decision Points in a Clinical Trial
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Front Matter
Pages 127-127
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 129-143
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 145-157
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 159-181
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 183-190
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- Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Pages 191-200
About this book
A few years ago, two of us joined our senior colleague at Pharma Kinetics Laboratories, a newly public contract research firm just under taking a major expansion into the clinical trials market. The company's unique concept of clinical research held great promise and had suc cessfully endured many of the fits and starts characteristic of entrepre neurial organizations. With a staff of highly enthusiastic, albeit inex perienced, field personnel located in 30-odd cities around the country, we found ourselves off and running with several critical research pro grams for major pharmaceutical manufacturers. Our excitement with the innovation was tempered with the reality of staffing and bearing responsibility for more than 30 field offices and 300 new staff persons, more than half of whom had no previous experience in the pharma ceutical industry. In the ensuing few years, we explored by trial and error many workable and unworkable patterns of training! delegation, data collec tion, and auditing. The ideas expressed in this book benefited greatly from that experience and from the willingness of our co-workers and clients to share insights and problems. During those years, we also sought guidance from the works available on the clinical trials field. Although we found numerous references on research ethics, little guid ance was available on the practical aspects of conducting a clinical trial.
Authors and Affiliations
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Hines Veterans Administration Medical Center and Loyola University Stritch School of Medicine, Mayfield, USA
Frank L. Iber
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University of Maryland School of Medicine, Baltimore, USA
Frank L. Iber
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Baltimore Medical System, Inc., Baltimore, USA
W. Anthony Riley
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Boston, USA
Patricia J. Murray