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, a global leader in real-world evidence (RWE) technology and analytics, today announced that the U.S. Food and Drug Administration’s (FDA) Office of Data Analysis and Research (ODAR) has extended its evaluation agreement with Aetion. Announced. Real World Data (RWD) including COVID-19 medical response. Under the contract extension, Aetion will expand its work evaluating data standardization in the context of COVID-19.
“As a scientific leader in producing real-world evidence for improved patient outcomes, Aetion is honored to continue working with the FDA.” Carolyn McGill, Chief Executive Officer and Director of Aetion. “We are working with the Office of Data, Analytics and Research to understand the impact of data standardization in developing real-world evidence at scale and speed to support pandemic preparedness. increase.”
The COVID-19 pandemic has demonstrated the need for robust RWD collection and analysis procedures to support rapid decision-making and deployment of medical measures. Aetion’s data standardization efforts will also support the FDA in this context and beyond, with the aim of providing generalizable learning to advance regulatory science.
Data standardization can support regulatory decision-making by improving data consistency and analytical reproducibility. However, if the data were collected for non-research purposes and later used to support regulatory decision-making (as is often the case with RWD), converting the data to a standard format may result in data loss or loss. , data elements may change. Under this contract extension, Aetion will support the FDA’s assessment of these effects in the COVID-19 environment.
End of second year of contract September 2023Throughout the next year, Aetion aims to work with the FDA to inform the usefulness of standardized data for regulatory purposes. These findings will be published in 2024. See below for additional information. https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/using-real-world-evidence-advance-covid-19-medical-countermeasures.
Aetion is a medical analytics company, providing real-world evidence to medical and technology manufacturers, purchasers and regulators. Aetion Evidence Platform® analyzes real-world data to rapidly generate scientifically validated and transparent answers about safety, efficacy and value.Founded by Harvard Medical School A faculty member with decades of experience in epidemiology and health outcomes research, Aetion informs the most important decisions in healthcare – what works best for whom, when, and helps guide product development, Leading innovation in merchandising and payments.Click here for details aetion.com follow us at @aetioninc.