The Food and Drug Administration has invested in real-world data for several years, seeing value in speedy collection of huge amounts of data. Now, it has turned this tool to COVID-19. The agency has partnered with health tech company Aetion to gather real-world data about the coronavirus.
The FDA and Aetion partnership aimed to gather information about the use of diagnostics and medications in the pandemic and about risk factors for COVID-19-related complications in different patient populations, according to the FDA announcement.
Aetion’s technology will analyze real-world data like electronic health records, insurance claims, patient registries and lab results to provide this guidance to the FDA. The data could also be used to evaluate potential therapies, vaccines or diagnostics for COVID-19.
“The FDA is applying data from diverse sources to inform its response to COVID-19, including sources that were already available to the agency, such as Sentinel,” said Amy Abernethy, principal deputy commissioner at the FDA, in a statement. “The urgency of addressing the COVID-19 pandemic has demanded that we expand our work to identify, access and analyze new datasets to widen the breadth of the information available.”
The FDA has previously worked with Aetion to gather real-world evidence. Last year, the two organizations worked on a project together that tried to determine whether real-world evidence can replicate the result of randomized clinical trials.
In fact, the agency has been more open to real-world data in recent years. In April 2019, for example, Pfizer’s breast cancer treatment Ibrance was approved to expand its label based on real-world evidence alone. In the past, the FDA typically accepted real-world evidence in tandem with clinical studies.
Under former FDA Commissioner Scott Gottlieb, the agency worked to implement more real-world data. In that framework, Gottlieb imagined using real-world data in the regulatory review of medicines, along with using it to monitor products’ safety after they hit the market.
In that 2018 framework, the FDA backed the use of real-word evidence to support revisions to a drug or biologic’s labeling, population or indication, including a change in dose, adding a new population or adding comparative effectiveness.
It has been about 18 months since the FDA issued that framework and the agency clearly continues to see the potential in real-world data, as both a faster and less expensive source of medical information.
During this pandemic, access to data quickly has been the name of the game with clinical trial regulations eased and pharma companies performing record-speed studies. This partnership to gather and analyze real-world data about COVID-19 is adding another source to the firehose of information about the virus.