Aetion announced the expanding its relationship with the FDA to use real-world evidence (RWE) to study COVID-19 interventions and advance regulatory science and innovation. FDA and Aetion will use Aetion Evidence Platform® (AEP), validated software that enables efficient, transparent, and reliable RWE research, to develop a framework and system of studies for the rapid assessment of COVID-19 inpatient medical products.
This project is designed to demonstrate how using a platform-based approach furthers regulatory learnings on the use of RWE to inform decision-making. The work will also provide a scalable infrastructure for the rapid development and evaluation of COVID-19 therapies, which can be applied for future public health emergencies. This contract will support the agency's broader digital transformation efforts, which include its Technology and Data Modernization Action Plans as well as its recently announced Office of Digital Transformation.
"COVID-19 has created an urgent need to develop and apply innovative methods to assess novel interventions," said Dr. Jeremy Rassen, co-founder and president of Aetion. "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."
The aim of this project is to further data familiarity and protocol standards to support real-world data (RWD) analyses among the broader research community. FDA will work with Aetion to define and prioritize key research questions; identify fit-for-purpose data sources; develop appropriate, validated, and applicable measurement algorithms to capture key exposures, subgroups, confounding variables, and outcomes; design template epidemiological studies applicable to a range of treatments; implement studies and generate transparent reporting using AEP; and build and disseminate knowledge via peer-reviewed publications and other avenues.
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