FDA Extends Aetion’s COVID-19 Real-World Data Contract

December 8, 2022

Aetion announced that the US Food and Drug Administration (FDA) has renewed its contract regarding real-world data (RWD) and COVID-19 treatment. As part of the collaboration, Aetion will continue to advance data standardization for RWD sources related to COVID-19. In doing so, the data resources will be evaluated to examine whether data standardization affected RWD sources not originally generated for research.

According to PR Newswire, “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.”

To read more, click here.

(Source: PR Newswire, December 7th, 2022)

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