The FDA and Aetion have announced an agreement to collaborate on advanced analytical techniques in an effort to answer urgent research questions about the coronavirus disease 2019 (COVID-19).1,2

Together, the FDA and Aetion, a health care technology company, aim to answer questions about the use of diagnostics and medications in the pandemic, and risk factors for COVID-19-related complications in different patient populations, according to Amy Abernethy, MD, PhD, Principal Deputy Commissioner, FDA.1

“We believe that this work has the potential to contribute to the scientific evaluation of potential diagnostics and interventions for COVID-19,” said Abernethy, in a prepared statement.1

The collaboration will rely on the Aetion Evidence Platform, a technology platform that includes structured workflows and transparent reporting to facilitate efficient sharing, examination, and reproduction of findings. According to Aetion, the company recently updated its platform to include medical and pharmacy claims, lab tests and results, hospital chargemaster data, and relevant EHR fields around COVID-19.2

Real-world data will be collected from a variety of sources that include electronic health records, insurance claims, patient registries, lab results, and wearable devices.1,2

According to Aetion CEO Carolyn Magill, it is critical that the data points gathered by health professionals be analyzed and disseminated in order to produce those actionable insights regarding COVID-19.2

Due to the COVID-19 pandemic, the FDA has worked with a sense of urgency to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources, according to Abernethy. Work is being done in collaboration with partners in the federal government, academia, and industry.1

“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. These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19,” said Abernethy in her statement.1

Officials with the FDA are regularly engaging with stakeholders, including medical product industry leaders and scientists, academic researchers, technology companies, state and local governments, and patient groups, in an effort to come together as a public/private health community that is harnessing the power of data during this emergency.1

“We’re optimistic that these efforts will assist in, among other things, the FDA’s work to facilitate medical countermeasures to diagnose, treat and prevent COVID-19, mitigate any potential shortages in the medical product and food supply chains, ensure the safety and quality of FDA-regulated products, and provide the industries we regulate with the tools and flexibility to do the same,” said Abernethy.1

REFERENCES
  1. Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response [news release]. Silver Spring, MD; May 19, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-collaborations-promote-rigorous-analyses-real-world-data-inform Accessed May 19, 2020.
  2. Keown A. Aetion and FDA Team Up for RWE Study to Advance Understanding of COVID-19. Aetion website. Published May 19, 2020. https://www.biospace.com/article/aetion-and-fda-collaborate-in-rwe-study-to-advance-understanding-of-covid-19/ Accessed May 19, 2020.