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A Quick Guide to Clinical Trials

  • Publication Date:April 2008
  • Publisher:BioPlan Associates
  • Product Type: Book
  • Pages:208
  • ISBN:978-1-934106-08-2

A Quick Guide to Clinical Trials

Quick Guide to Clinical Trials provides a fresh overview of the clinical trials process, history, and background. Written by major industry experts, including the US FDA, and some of the largest international clinical trials managers, this book provides an easy-to-read, conversational view point on the importance, the shortcomings, and intricacies of the clinical trials process. It is intended for those new to clinical trials, as well as knowledgable readers, industry participants, and even patients considering participating in clinical trials. A broad audience can appreciate the content because it includes little-known facts and information, as well as solid, but easily managed, technical material.

  • Introduction: What's in it for me: why should I read this book? xv Drs. Madhu Davies and Faiz Kermani
    • Chapter 1: Why do we do clinical trials? 1 Dr. Graham Wiley, CEO, Medical Research Network
    • Chapter 2: The FDA and clinical trials: a short history 21 Dr. Suzanne Junod, Food and Drug Administration
    • Chapter 3: The business of successful clinical drug development 53 Drs. James McClurg and Todd Johnson
    • Chapter 4: The clinical trial process: project management 63 Mrs Jan Robinson, PharmaKodex Ltd
    • Chapter 5: The clinical trial process: primer on ethics in clinical research 77 Dr. Felix Khin-Maung-Gyi, CEO Chesapeake Research Review Inc
    • Chapter 6: The clinical trial process: regulatory affairs 93 Mrs. Sue Green, Shore Ltd
    • Chapter 7: The clinical trial process: monitoring 109 Drs. Ignazio di Giovanni/Gareth Hayes Campbell Charles Associates Ltd and PhlexGlobal Ltd
    • Chapter 8: The clinical trial process: statistics 121 Dr. Cathy O'Brien Fincham Statistics
    • Chapter 9: The clinical trial process: data management 133 Mrs. Lisa Nash, GlaxoSmithKline
    • Chapter 10: The clinical trial process: technology in clinical trials 149 Drs. Bill Byrom and David Stein, Clinphone Ltd
    • Chapter 11: Clinical trials and medical writing 163 Mrs. Fiona Swain, Swain Associates
    • Chapter 12: Clinical trials and the clinical research physician 177 Dr. Madhu Davies
    • Chapter 13: Clinical trials and the patient 187 Mrs. Liz Langley, LHA Ltd
    • Chapter 14: The future of clinical trials 197 Dr. Faiz Kermani
    • Glossary
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