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
TYPES OF RISK IN CLINICAL TRIALS
The Life Cycle of a Clinical Trial
Typical Risks that Clinical Trial Projects Face
Internal and External Risks
Brainstorming a Risk Assessment
Compiling a Risk Register
Assessing Impact and Probability
THREATS AND OPPORTUNITIES
Responding to Threats
Stakeholder Needs and Risk Tolerance
PLANNING PREVENTATIVE STRATEGIES
Creating s Prevention Plan
Controlling the Critical Path
Responding to Deviations
Continuous Risk Management
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
"…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."
"…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