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1st Edition

Clinical Trials Risk Management




ISBN 9780849333231
Published October 12, 2005 by CRC Press
232 Pages

 
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Book Description

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.
  • Table of Contents

    DEFINITIONS AND CONCEPTS
    What is Risk?
    The Principles of Risk Management
    Drug R&D: A Risky Business
    Why Risk Management in Important in Clinical Trials

    DRUG SAFETY AND PHARMACOVIGILANCE
    USA
    Japan
    European Union

    TYPES OF RISK IN CLINICAL TRIALS
    The Life Cycle of a Clinical Trial
    Typical Risks that Clinical Trial Projects Face
    Internal and External Risks

    RISK IDENTIFICATION
    Brainstorming a Risk Assessment
    Compiling a Risk Register
    Assessing Impact and Probability
    Simulation Models

    THREATS AND OPPORTUNITIES
    Responding to Threats
    Maximizing Opportunities
    Stakeholder Needs and Risk Tolerance

    PLANNING PREVENTATIVE STRATEGIES
    Assessing Cause
    Creating s Prevention Plan
    Controlling the Critical Path

    BACKUP PLANNING
    Contingency Planning
    Trigger Points

    TRACKING RISKS
    Detecting Symptoms
    Responding to Deviations
    Continuous Risk Management
    Decision Milestones

    INVESTIGATIONAL SITE RISK MANAGEMENT
    The Role of the CRA in Individual Site Risk Assessment
    Initial Risk Analysis Before and During the Prestudy Visit
    Using the Initiation Visit for Risk Prevention
    Ongoing Risk Management through Monitoring

    POST PROJECTION EVALUATION
    Reviewing Success of Risk Management Strategy
    Learning Lessons for the Future

    ...
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    Reviews

    "…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