Aetion Furthers Collaboration with FDA on Real-World Data
Partnership leverages Aetion’s platform for analyzing real-world data to generate evidence and support regulatory decision-making
NEW YORK, December 7, 2022 /PRNewswire/ ‒ Aetion, the global leader in real-world evidence (RWE) technology and analytics, today announced the U.S. Food and Drug Administration (FDA)’s Office of Data, Analytics and Research (ODAR) extended Aetion’s contract to evaluate real-world data (RWD) involving COVID-19 medical countermeasures. Under the contract extension, Aetion will expand its work to evaluate data standardization in the context of COVID-19.
“As a scientific leader in generating real-world evidence to improve patient outcomes, Aetion is honored to continue our collaboration with the FDA,” said Carolyn Magill, Chief Executive Officer and Board Director at Aetion. “We will work alongside the Office of Data, Analytics and Research to understand the impact of data standardization on developing real-world evidence at scale and at top speed to support pandemic preparedness.”
The COVID-19 pandemic demonstrated a need for robust RWD collection and analysis procedures to support expedited decision-making and deployment of medical countermeasures. Aetion’s work on data standardization will support FDA both in this context and, by aiming to provide generalizable learnings to advance regulatory science, outside the pandemic setting as well.
Data standardization can support regulatory decision-making by improving the consistency of data and the reproducibility of analyses. However, when data are collected for non-research purposes and then later used in support of regulatory decision-making (as often happens with RWD), transforming the data into a standard format can potentially result in data loss or the alteration of data elements. Under this contract extension, Aetion will be supporting FDA’s evaluation of these impacts in the COVID-19 setting.
The second year of the contract runs through September 2023. Throughout the next year, Aetion, in collaboration with FDA, aims to inform the usability of standardized data for regulatory purposes. These findings are expected to be published in 2024. For additional information visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/using-real-world-evidence-advance-covid-19-medical-countermeasures.
Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare’s most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at aetion.com and follow us at @aetioninc.
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