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

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 of potential therapeutic approaches as well as the downstream effects of the disease itself, Principal Deputy Commissioner Amy