The U.S. Food and Drug Administration announced this week that it will work with data analytics company Aetion to answer outstanding questions about the COVID-19 crisis.
Using real-world evidence around the populations affected by COVID-19 and the efficacy of treatments for those patients, the FDA hopes to advance research about the disease in a timely fashion.
WHY IT MATTERS
Knowledge about the effect of the novel coronavirus on patients has evolved at a breakneck pace. Evidence continues to emerge about the disproportionate impact faced from COVID-19 by people of color, older people and people with some pre-existing conditions, among others.
Aetion and the FDA plan to pinpoint COVID-19 risk factors and evaluate potential COVID-19 treatments by analyzing real-world evidence.
“Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages,” said FDA Principal Deputy Commissioner Amy Abernethy in a statement.
“These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19,” Abernethy continued.
Aetion explained in a press statement that the partnership will rely on the company’s Evidence Platform, which is built to enable more transparent reporting and easier sharing of analysis and reproduction of real-world evidence findings.
The company says it hopes to help the FDA research the disease’s history as well as diagnostic patterns.
“The urgency of addressing the COVID-19 pandemic has demanded that we expand our work to identify, access and analyze new datasets to widen the breadth of the information available,” said Abernethy.
“This work is being done in collaboration with partners in the U.S. government, academia and industry,” she continued.
THE LARGER TREND
Real-world data can inform stakeholders of how well medical interventions work for populations who may have otherwise been overlooked.
“Our platform takes real-world data – data collected outside of a clinical trial or controlled setting – to create real-world evidence at scale,” said Aetion CEO Carolyn Magill in 2019.
“Most of our clients are biopharma, and they are licensing the platform to assess the safety, effectiveness and value of medication,” she explained. “They’re really trying to understand how to get a better sense of how their medications work.”
The FDA has turned to real-world data for more than a decade in an effort to track medical-product safety.
In 2008, it began development on its Sentinel system, which enabled monitoring of potential adverse events after drugs and medical devices enter the market. Sentinel is among the sources from which the agency will be drawing data for its Aetion partnership.
In 2015, the FDA announced a $1 million grant toward analyzing data from electronic health records to surveil medication efficacy.
And earlier this year, the agency made its MyStudies app, designed to facilitate patient sharing of real-world data, available on Google Cloud.
“By building on the platform developed by the FDA, we hope to stimulate an open ecosystem that will improve the ability of organizations to perform research that leads to better patient outcomes,” said Jameson Rogers, product manager at Google Cloud Healthcare & Life Sciences.
ON THE RECORD
“In recent years, the agency has taken steps to leverage modern, rigorous analyses of real-world data – such as data from the health care setting – to inform our work,” said Abernethy.
“The COVID-19 pandemic has brought an urgency to these efforts and the FDA has worked quickly to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources,” she continued.
Kat Jercich is senior editor of Healthcare IT News.
Healthcare IT News is a HIMSS Media publication.
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