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Conducting Clinical Trials

  • Book
  • © 1987

Overview

Authors:
  1. Frank L. Iber

    1. 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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  2. W. Anthony Riley

    1. Baltimore Medical System, Inc., Baltimore, USA

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    You can also search for this author in PubMed   Google Scholar

  3. Patricia J. Murray

    1. Boston, USA

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Table of contents (29 chapters)

  1. Front Matter

    Pages i-xii
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  2. Introduction

    1. Front Matter

      Pages 1-1
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    2. Introduction

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 3-17

  3. Entering the Field of Clinical Trials

    1. Front Matter

      Pages 19-19
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    2. Deciding to Enter the Research Field

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 21-28

    3. Physicians

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 29-41

    4. Evaluating a Sponsor

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 43-50

    5. Budget Planning and Development

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 51-66

    6. Staff Selection and Training

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 67-76

    7. Other Preparatory Activities

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 77-81

  4. The Institutional Review Mechanism

    1. Front Matter

      Pages 83-83
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    2. The Institutional Review Board Process

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 85-103

  5. The Recruitment Process

    1. Front Matter

      Pages 105-105
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    2. Recruitment

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 107-125

  6. Critical Decision Points in a Clinical Trial

    1. Front Matter

      Pages 127-127
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    2. Informed Consent: Decision amid Uncertainty

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 129-143

    3. Special Populations

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 145-157

    4. The Enrollment/Continuation Decision

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 159-181

    5. Compliance of Patients Currently on Study

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 183-190

    6. Adverse On-Therapy Experiences

      • Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 191-200
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Keywords

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

  • Hines Veterans Administration Medical Center and Loyola University Stritch School of Medicine, Mayfield, USA

    Frank L. Iber

  • University of Maryland School of Medicine, Baltimore, USA

    Frank L. Iber

  • Baltimore Medical System, Inc., Baltimore, USA

    W. Anthony Riley

  • Boston, USA

    Patricia J. Murray

Bibliographic Information

  • Book Title: Conducting Clinical Trials

  • Authors: Frank L. Iber, W. Anthony Riley, Patricia J. Murray

  • DOI: https://doi.org/10.1007/978-1-4613-1919-1

  • Publisher: Springer New York, NY

  • eBook Packages: Springer Book Archive

  • Copyright Information: Plenum Publishing Corporation 1987

  • eBook ISBN: 978-1-4613-1919-1Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: 366

  • Number of Illustrations: 4 b/w illustrations

  • Topics: Pharmacology/Toxicology, Medicine/Public Health, general

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