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Pink Sheet – Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets

Pink Sheet – Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets

Executive Summary

FDA’s Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens. Aetion’s ability to perform consistent analyses across a variety of data sets was key for FDA in selecting the the partnership, which grew from Reagan-Udall Foundation and Friends of Cancer Research’s Evidence Accelerator project.

The US Food and Drug Administration announced a new COVID-19 real-world data partnership with Aetion this week, a collaboration that was attractive to the regulatory agency because of Aetion’s ability to provide consistent analysis across multiple different data sets, Principal Deputy Commissioner and Acting Chief Information Officer Amy Abernethy told the Pink Sheet.


The Aetion platform provides “a mechanism for consistent analysis of different real-world data sets so that then we can then be able to consider what happens when the same question is analyzed in a consistent way across multiple different underlying datasets. That is the aspect of their analytic platform that was intriguing and we wanted to drill down on further and was the motivation behind setting up a research collaborative agreement,” Abernethy said in an interview.


FDA also values the transparency of the Aetion platform, which allows the agency to clearly understand how analyses are being done, Abernethy added. Another key factor was scalability.


“The ability to do large volumes of important deliberative and high quality work at scale, because there’s so much do within the context of COVID-19. So I’m constantly looking at what solutions help to scale high quality deliberative work,” Abernethy said.


Aetion CEO Carolyn Magill said the company’s key benefit is that they are “fluent across datasets” from multiple providers and that their platform was built to transform this data into “decision grade real world evidence,” with transparent, valid and replicable analyses.


The partnership gives FDA direct access to Aetion’s platform, Magill said, and will also allow for the company to collaborate with the agency. They aim to work together to ensure they are choosing the right data sources for the questions they want to answer and structure studies so they are credibly designed and can be reproduced.

Natural History Of COVID-19 Is Job One

The partnership emerged from the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Evidence Accelerator, which was created to allow data organizations, government and academic researchers and health systems to gather and design quires that can be quickly turned around and lead to shared results (Also see “Real-World Evidence On COVID-19: US FDA Approaching With ‘Sense Of Urgency'” – Pink Sheet, 22 Apr, 2020.).


Aetion is part of the evidence accelerator’s parallel analysis work stream where various groups run analyses in parallel using different analytical techniques and data sources to help validate the role of real-world evidence as a tool for learning about COVID-19.


Abernethy said FDA and Aetion are still working out the specific details of what they will research under the partnership but initial priorities are likely to be centered on better understanding the natural history of COVID-19, what medications doctors are prescribing for the virus and how they may be impacting patients, along with how patients who have other diseases and get COVID-19 are faring in response to treatments.


FDA will work with Aetion on “advanced analytical techniques” that can answer a range of COVID-19 questions including risk-factors for COVID-19 complications in various patient populations, an agency statement said. FDA also has a number of similar projects underway to understand COVID-19 using its Sentinel system (Also see “COVID-19 Shakes Up Real-World Data Studies” – Pink Sheet, 27 Apr, 2020.).


Understanding natural history “is job number one,” Jeremy Rassen, Aetion President and Chief Scientific Officer said, because it will help researchers to understand the populations a drug may be more effective in or in which patients a treatment may work differently than average.


For example, natural history data may help point to patient risk factors that may alter the performance of a drug.  This will help with determining what populations a clinical trial should target and help with finding those patients for the trials, Rassen said.

Assessments Throughout The Lifecycle

Aetion’s believes the partnership should ultimately be able to help FDA in its assessment of drugs, vaccines and diagnostics for COVID-19 throughout the regulatory life cycle from clinical trials to post-market.


“As RCTs [randomized control trials] are in progress, we believe real-world data can yield evidence that compliment those RCTs to ensure that we are supplementing the knowledge and responding to some of the urgent needs we have around approval and safety and effectiveness.” Magill said.


Aetion is also preparing for safety assessments the agency may want to do when a COVID-19 vaccine comes onto the market.


If successful, the partnership could set the stage for the future use of real-world data in other disease areas.


“We’re seeing with COVID-19 an acceleration of the shift toward continuous evidence generation,” Magill said. There’s also been an acceleration in the understanding of how to create that evidence and establish credible standards for real-world data, she said.


Abernethy couldn’t put a timeline on the project with Aetion but said they will work fast without sacrificing quality. “One of the things that will come up over and over again is we need to be both fleet of foot but also attend to making sure that we get the details right,” she said.…