- The Food and Drug Administration is upping efforts to incorporate real-world data in the evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday its participation in a partnership exploring how to use this data to improve testing quality, better inform population testing strategies, and help understand how widespread the virus is.
- Using real-world data and evidence in regulatory decision-making has been on the FDA's agenda for a few years. But the pandemic sped up the adoption of newly generated data so that guidelines could be updated for coronavirus tests that were cleared for emergency use based on limited information, Commissioner Stephen Hahn said during a fireside chat with the Medical Device Innovation Consortium, or MDIC.
- In recent weeks, the agency has shown that it's willing to reverse course on the products it allows during the public health emergency, as additional insights on efficacy come to light. This week, for example, the FDA revoked the emergency use authorization for a COVID-19 antibody test from Chembio, one of the earliest of such tests to have received an EUA, or emergency use authorization.
Real-world evidence provides insights on the benefits or risks of a medical product taken from real-world data, which is information derived from registries, electronic health records, claims and billing data, as well as mobile devices and other sources that reflect patients' actual use of products.
In recent years, the FDA has paid closer attention this data and how it could be used to improve decision making. In 2016, the agency provided $3 million to get off the ground the National Evaluation System for health Technology Coordinating Center, which aims to research medical technologies using retrospective and active sources of real-world data.
On the drugmaking side, FDA leaders have signaled that, while companies shouldn't rely too heavily on real world evidence, the agency is open to evaluating this information and allowing it to be use for expanding a drug's label. The agency also recently said it is advancing real-world data tools to help speed up development of COVID-19 treatments. The FDA said these tools will help analyze outcomes and illness patterns, and could help to supplement placebo-controlled trials.
With the agency leaning heavily on the emergency use pathway during the COVID-19 public health crisis, the need to revisit and update authorizations once new evidence emerges on specific products and the virus itself is arguably more apparent now than ever before.
"You take the data you have, you take the information you have, you make decisions, and then you update it as you go based on new information," Hahn said during a question and answer session with MDIC President Pamela Goldberg on Thursday. "And I think that's what we've seen here during this pandemic. It's what the agency has always strived to do, we've just done it in an accelerated timetable."
Hahn said the agency has tried to best balance the need for speedy access to products that can help in the fight against the new coronavirus while continuing to ensure safety and effectiveness and being transparent about its processes.
Still, "in a fast-moving pandemic, that's been a challenge," he said.
The FDA has been criticized for getting that balance wrong in some cases. For example, it allowed scores of antibody tests onto the market without agency review under an umbrella-type policy aimed at increasing the volume of tests available. Many of those tests were found to have high rates of false results, prompting the agency to later order some off the market and require emergency use authorizations for all test makers wishing to continue selling a product.
Thursday's announcement on FDA's participation in the COVID-19 Diagnostics Evidence Accelerator could help, though. The initiative is organized by the Reagan-Udall Foundation, a nonprofit that supports FDA, and Friends of Cancer Research, following a similar accelerator focused on therapeutics.
Among other efforts, the diagnostics accelerator will tackle a key question in understanding of the virus: whether the presence of antibodies signals protection against future infection, and if so, which ones help.
"We recognize that questions related to the accuracy of diagnostic tests require different data elements that are not as widely available as those in the therapeutic space. They also require a different approach to data integration and analysis," Center for Devices and Radiological Health Director Jeff Shuren said in a statement. "Ultimately, we hope that real-world data can provide a more generalizable and rapid read-out of results than traditional clinical trials."
On both the diagnostics and therapeutics fronts, the agency said in mid-May it was engaging Aetion, a New York-based healthcare technology company that specializes in analyzing real-world evidence for payers, providers and regulators, to address questions about tests and medications — as well as risk factors for COVID-19 complications in various patient populations. The agency also said it's leveraging Sentinel, its electronic system used to surveil medical product safety.
The FDA's focus on real-world evidence will continue beyond the current COVID-19 pandemic, Hahn said.
"Now as we look forward, we need to think about how real-world evidence fits into the initial authorization or approval of a product," he said. "But on the [post-approval end], what data can we collect to look at really how these devices, how the tests operate, how they perform, and then incorporate that back in?"