The Food and Drug Administration has contracted with real-world evidence company Aetion to use their platform for the assessment of COVID-19 inpatient medical products, the company announced today.
The Aetion Evidence Platform, which analyzes real-world data (RWD) pulled from electronic health records and medical claims, will enable the FDA to assess inpatient COVID-19 treatments in real-time.
“As part of this agreement, they’ll be able to apply the best practice science to different real-world data sources that are fit for the purpose of understanding inpatient treatments, learn to do this themselves and be able to apply it now or to other questions that emerge in the future,” said Jeremy Rassen, Sc.D., co-founder of Aetion, in an interview with Fierce Healthcare.
Aetion’s real-world evidence (RWE) model offers an alternative to clinical trials, which, while an important part of the scientific process, take much longer to conduct than a public health crisis like a pandemic can afford, Rassen said.
“This pandemic has thrown a lot of questions at us, some of which were anticipated and some of which were not, so a key part of that is being able to answer those critical and emergent questions in the moment,” he said.
The Aetion Evidence Platform is available in the cloud, on-premises, or in a hybrid format, giving organizations flexibility in performing rapid-cycle analytics.
Aetion was the first RWE company to establish an FDA COVID-19 Research Collaboration Agreement in May 2020. The original agreement was created to assess how RWD could be used to understand and respond to the evolving pandemic.
The startup raked in $110 million in its series C funding round in May, bringing the company’s total amount raised during funding rounds to $212 million.
The RWE model may often allow for a more diverse patient population in treatment analyses than clinical data can provide, Rassen said.
“The nice thing about it is that because it’s not being generated specifically for research patients, it represents a broader group of patients, much broader than you’d get in a clinical trial. So you get more information about a broader range of experiences out in the world,” he said.
The platform could also empower the federal agency to analyze RWD in the event of future public health emergencies, the company said in a statement.
“COVID-19 has created an urgent need to develop and apply innovative methods to assess novel interventions,” said Rassen in the statement. “As FDA continues to advance its digital capabilities, Aetion is proud to partner with the agency in developing the rigorous scientific processes and RWE generation tools needed to quickly respond to future public health challenges.”