Aetion, FDA Partner on Oncology Real-World Data

FDA's Oncology Center of Excellence (OCE) is partnering with Aetion, a startup focusing on real-world evidence in healthcare.

In the five-year research collaboration, the OCE will use Aetion's Evidence Platform to find and analyze sources of real-world data that could be used for research on cancer prevention, clinical care, diagnostics and treatment. The collaboration will also assess real-world endpoints, measure healthcare disparities and evaluate causal inference methods. The research will take place until 2027. 

"We are proud to partner with FDA's Oncology Center of Excellence to conduct crucial research to advance the use of real-world evidence and to help better serve vulnerable and underrepresented populations," Carolyn Magill, CEO of Aetion, said in a statement. "Our collaboration furthers our mission to understand which treatments work for which patients and brings us closer to achieving health equity among cancer patients."

Earlier in 2019, Sanofi merged its real-world data platform with Aetion's Evidence Platform. Sanofi's real-world data platform, DARWIN, provided de-identified patient data that Aetion's Evidence Platform would analyze for insights on drug effectiveness, safety and value. 

In 2020, Aetion also partnered with healthcare data platform HealthVerity to launch tools to help biopharma companies and regulators find COVID-19 treatments. 

In December 2022, Aetion announced the FDA's Office of Data Analytics and Research extended its contract through 2023, to examine real-world data regarding COVID-19 medical countermeasures and to evaluate data standardization in the context of COVID-19.  

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