Risk-Based Monitoring: US FDA Clarity And Industry Standards Aren't Enough

 
• By Sue Sutter

Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.

Various of ice cream flavor in cones blueberry ,strawberry ,pistachio ,almond ,orange and cherry setup on dark stone background . Summer and Sweet menu concept. - Image
Like the basic recipe for ice cream, risk-based monitoring may need some general standards that can be adapted by different sponsors and CROs. • Source: Shutterstock

Hoping to drive greater adoption of risk-based monitoring, the US Food and Drug Administration is trying to clear up industry misconceptions of what this approach to overseeing clinical trial quality does and does not involve.

However, it likely will take more than a clarification of definitions and terminology to overcome what pharmaceutical manufacturers, contract research...

More from Clinical Trials

More from R&D