“COVID-19 has delivered an unprecedented shock to the healthcare system and brings new urgency to how we analyze real-world patient experiences,” said Jeremy Rassen, co-founder, president, and chief science officer at Aetion. “By conducting real-world evidence studies that apply the highest scientific standards, we can support the FDA as it advances an evidence-based understanding of COVID-19.”Image Credit: Adobe Stock
If it takes a village to raise a child, it takes an entire world to defeat a pandemic. That sentiment is becoming more evident every day as we see cross-industry collaborations and public-private partnerships evolving to combat COVID-19.
Take, for example, a new agreement between FDA and Aetion, a venture-backed healthcare data analytics company based in New York, NY. The partnership aims to assess real-world data sets to generate clinical insights about the course and treatment of the novel coronavirus.
"We believe that this work has the potential to contribute to the scientific evaluation of potential diagnostics and interventions for COVID-19," Amy Abernethy, MD, PhD, principal deputy commissioner at FDA, said in an agency statement. "The FDA continues to work around the clock to respond to the COVID-19 pandemic. As part of this effort, we recognize the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries, and lab results to further inform our science-based, all-of-America response to this unprecedented public health emergency."
Abernethy points out that in recent years the agency has taken steps to leverage modern, rigorous analyses of real-world data to inform its work. She says the COVID-19 pandemic has brought an urgency to these efforts and the agency has worked quickly to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources.
"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," Abernethy said. "These data can also inform ongoing work to evaluate potential therapies, vaccines, or diagnostics for COVID-19."
The agreement calls for Aetion and FDA to identify and analyze fit-for-purpose data sources to characterize COVID-19 patient populations and their medication use, identify risk factors for COVID-19-related complications, and contribute to the scientific evaluation of potential interventions. The collaboration will make use of the Aetion Evidence Platform, which includes structured workflows and transparent reporting to facilitate efficient sharing, examination, and reproduction of findings.
"As regulators and industry mobilize to address COVID-19, it’s critical that we learn from the data generated by the healthcare system," said Carolyn Magill, CEO of Aetion. "This collaboration will employ Aetion’s analytic platform and a variety of real-world data sources to rapidly, reliably, and transparently produce actionable insights to serve patients and address the daily challenges they face.”
In addition to working with other government, academic, and industry partners, FDA said it is also applying data from sources like Sentinel, an initiative the agency first proposed in 2007, to inform its response to the pandemic. FDA also participates in the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation, which brings together leading experts in health data aggregation and analytics in an effort to share insights, compare results, and answer key questions to inform the collective COVID-19 response.