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Conducting Clinical Trials

  • Frank L. Iber
  • W. Anthony Riley
  • Patricia J. Murray

Table of contents

  1. Front Matter
    Pages i-xii
  2. Introduction

    1. Front Matter
      Pages 1-1
    2. 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
    2. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 21-28
    3. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 29-41
    4. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 43-50
    5. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 51-66
    6. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 67-76
    7. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 77-81
  4. The Institutional Review Mechanism

    1. Front Matter
      Pages 83-83
    2. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 85-103
  5. The Recruitment Process

    1. Front Matter
      Pages 105-105
    2. 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
    2. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 129-143
    3. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 145-157
    4. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 159-181
    5. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 183-190
    6. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 191-200
    7. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 201-214
  7. Data Management

    1. Front Matter
      Pages 215-215
    2. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 217-222
    3. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 223-229
    4. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 231-237
    5. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 239-243
    6. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 245-248
    7. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 249-250
    8. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 251-256
    9. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 257-261
    10. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 263-267
  8. Drug Accountability

    1. Front Matter
      Pages 269-269
    2. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 271-278
  9. Enhancing Credibility

    1. Front Matter
      Pages 279-279
    2. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 281-287
    3. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 289-306
    4. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 307-313
    5. Frank L. Iber, W. Anthony Riley, Patricia J. Murray
      Pages 315-323
  10. Back Matter
    Pages 325-353

About this book

Introduction

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.

Keywords

clinical research clinical trial drug ethics kinetics planning quality assurance research therapy

Authors and affiliations

  • Frank L. Iber
    • 1
    • 2
  • W. Anthony Riley
    • 3
  • Patricia J. Murray
    • 4
  1. 1.Hines Veterans Administration Medical Center and Loyola University Stritch School of MedicineMayfieldUSA
  2. 2.University of Maryland School of MedicineBaltimoreUSA
  3. 3.Baltimore Medical System, Inc.BaltimoreUSA
  4. 4.BostonUSA

Bibliographic information