FDA research collaboration to use real-world data to help study COVID-19
Aetion (NY, USA) has signed a research collaboration agreement with the US FDA to analyze real-world data to help advance understanding of COVID-19, its natural history and potential treatment approaches.
Aetion (NY, USA) has announced it has signed a research collaboration agreement with the US FDA to analyze real-world data and generate real-world evidence to help advance understanding of COVID-19, its natural history and potential treatment approaches, which supports the FDA’s objectives to employ novel data sources to study COVID-19.
Amy Abernethy, Principal Deputy Commissioner of Food and Drugs at the FDA, commented: “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.”
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There are currently more than 300 potential treatments and vaccine candidates in development and/or being investigated in clinical trials for COVID-19, with more being progressed constantly. You can read about the latest developments on our sister site, Infectious Diseases Hub, here>>
Clinical trial planning and participant recruitment are significant challenges many researchers are and will be facing, reinforcing the need for timely, relevant real-world data and evidence.
In an interview with The Evidence Base®, Philip Robinson (Royal Brisbane & Women’s Hospital; Brisbane, Australia), explained: “In the absence of any information, observing real-world outcomes from large numbers of cases helps both inform current healthcare practice, as well as highlight patterns that may warrant further investigation with more robust research techniques.”
This collaboration will leverage the Aetion Evidence Platform® to help analyze fit-for-purpose, real-world data sources, to help characterize COVID-19 patient populations and risk factors for COVID-19-related complications, as well as evaluate potential treatment strategies.
Aetion President, Jeremy Rassen, concluded: “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.”
Sources:
www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-collaborations-promote-rigorous-analyses-real-world-data-inform; www.aetion.com/press-release/aetion-launches-research-collaboration-with-fda-to-advance-understanding-of-covid-19