Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency'

Apr 22 2020

• By Sue Sutter

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Agency is going outside its ‘comfort zone’ to leverage different streams of existing real-world data sources to quickly assess the impact of potential treatment approaches, Amy Abernethy says; pandemic experience could lead to a more open embrace of RWE beyond the current public health emergency.

Many bubbles in water close up, abstract water wave with bubbles — US FDA is evaluating results that have bubbled up from different data streams organized into a series of critical categories. • Source: Shutterstock

The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a potentially lasting and positive impact on the agency’s view of the utility of RWE to support – or even guide – drug approvals and labeling expansions beyond the context of the current public health emergency.

The agency is trying to leverage existing real-world data sources, such as electronic health records, to quickly assess the impact...

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