Skip to Content

Clinical Trials Risk Management

By Martin Robinson, Simon Cook

CRC Press – 2006 – 232 pages

Purchasing Options:

  • Add to CartHardback: $159.95
    978-0-8493-3323-1
    October 11th 2005

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.

  • 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

    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

    Name: Clinical Trials Risk Management (Hardback)CRC Press 
    Description: By Martin Robinson, Simon Cook. 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...
    Categories: Clinical Implementation, Healthcare Management, Medicinal & Pharmaceutical Chemistry