Clinical Trials Risk Management

Martin Robinson author Simon Cook author

Format:Hardback

Publisher:Taylor & Francis Inc

Published:12th Oct '05

Currently unavailable, and unfortunately no date known when it will be back

Clinical Trials Risk Management cover

Drug development is risky business. It is against the backdrop of huge financial, scientific, technical and medical risks that a clinical trials manager is expected to function, effectively identifying and managing all project risks, to deliver a successful outcome. Focusing on the day-to-day needs of a clinical trials manager, Clinical Trials Risk Management explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to 'real life' clinical trial situations.

After building a foundation of basic principles, the authors lead you through specific methods for handling the risks characteristically encountered in clinical trials. Their combined years of experience in pharmaceutical research and development shine through the narrative, making the prose both lively and informative. They discuss concepts using worked examples and include a summary of the main points at the end of each chapter. In addition to diagrams and Risk and Precision Tree charts, the text is sprinkled with humorous line drawings that reinforce the concepts.

After reading this book, you will know how to:

  • Prepare a Risk Assessment
  • Design an Impact-Probability Matrix
  • Compile a Risk Register
  • Run a Monte Carlo Simulation
  • Set up a Project Decision Tree
  • Plan preventative and contingency actions

    The stand-alone chapters provide easy access to topics, while anecdotal and visual examples make them easy to remember. Martin Robinson and Simon Cook deliver a clear interpretation of complex information, thus saving you the time it would take to wade through a lengthier text, adopting a straightforward approach to examining clinical trials from a risk manager's perspective. A practical, readable guide, the book is filled with information that can be put to immediate use to improve current or planned clinical trials.<

    • "…fills a key niche as there are few concise books offering a practical, readable guide to risk management."
    -Institute of Clinical Research

    "A practical, readable guide, the book is packed with information that can be put to immediate use to improve current or planned clinical trials."
    --Anticancer Research

    "…a welcome addition to the clinical researcher's essential reading list…The book is well organized and, for a technical subject, easy to read, helped enormously by the use of humourous illustrations that gently emphasize the points being made…I can recommend this book to everyone working at the sharp end of clinical drug development."
    -Good Clinical Practice Journal

    ISBN: 9780849333231

    Dimensions: unknown

    Weight: 590g

    232 pages