FDA, Aetion dive into the real-world data surrounding COVID-19

FDA
Aetion and the FDA plan to follow medication use and use the evidence generated in evaluations of new potential interventions. (Andrew Harnik, Associated Press)

The FDA is tapping its real-world data partner Aetion for new research tracking the spread of COVID-19. 

The project will include gathering information on diagnostic and treatment patterns to help the agency better understand the natural course of the novel coronavirus.

Sponsored by GenScript

Accelerate Biologics, Gene and Cell Therapy Product Development partnering with GenScript ProBio

GenScript ProBio is the bio-pharmaceutical CDMO segment of the world’s leading biotech company GenScript, proactively providing end-to-end service from drug discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers.

"The FDA is approaching the generation of real-world evidence for COVID-19 with a sense of urgency to learn what we can, as soon as we can, from patients who are receiving care right now," said the FDA’s principal deputy commissioner, Amy Abernethy. 

"We also recognize that COVID-19 is a dynamic situation. We can use current data and learn what decisions we can confidently make now, and we can learn what we'll need to do in the future as more data become available," Abernethy said. 

Additionally, Aetion and the FDA plan to identify risk factors for complications related to the disease. The project will also follow medication use, and the evidence generated will contribute toward evaluations of new potential interventions.

RELATED: Using real-world data, the FDA aims to predict randomized trial results before they're done

Currently, over 300 treatments and vaccines are being developed for COVID-19, with companies eager to get them across the desks of the FDA’s reviewers. 

"As regulators and industry mobilize to address COVID-19, it's critical that we learn from the data generated by the health care system," said Aetion CEO Carolyn Magill. "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."

And though many developers are facing obstacles in clinical trial planning and recruitment, Aetion says valid real-world data and evidence could help shore up the development process.

"COVID-19 has delivered an unprecedented shock to the health care system and brings new urgency to how we analyze real-world patient experiences," said Aetion’s president, chief science officer and co-founder, Jeremy Rassen. "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."

Suggested Articles

Bayer strengthened its ties with Scottish AI developer Blackford Analysis to build a one-stop shop for applications in medical imaging.

While the biotech IPO market booms, it can look like going public is easy. But the right strategy, syndicate and aftermarket are still important.

Boston Scientific has moved to hive off the specialty pharmaceuticals division it picked up through last year’s $4.2 billion acquisition of BTG.