A software startup struck a five-year collaborative research program with the Food and Drug Administration as part of a broader push by the agency to use more real-world data for regulatory decisions.
Real-world data is gathered outside of the context of a clinical trial, such as information from electronic health records, claims data, lab tests and wearable devices. That information can be analyzed and used as real-world evidence. The FDA already has programs to monitor the safety of drugs after approval using insurance claims data, but is also looking to integrate real-world evidence into other regulatory decisions.
Boston-based ConcertAI will work with the agency to better understand the safety and efficacy of current standard of care cancer treatments within different groups of patients, CEO Jeff Elton wrote in an emailed statement. The startup is also working with the FDA to come up with strategies for how to best use real-world evidence in other regulatory decisions based on this information.
The startup was founded in 2018, and has struck a growing number of deals with drugmakers to use its AI solutions and repository of oncology data. For example, it has landed partnerships with Bristol-Myers Squibb, Astellas and Pfizer.
“As a part of the FDA’s Real-World Evidence Program, the agency has multiple work streams and collaborations aiming to inform the potential utility of (real-world evidence) in therapeutic development and regulatory decision making,” Qi Liu, senior science advisor for the FDA’s Office of Clinical Pharmacology, said in a news release. “Our collaboration with ConcertAI can enable us to explore and evaluate the reliability of new methods, and identify relevant use cases, and ultimately advance the knowledge for all involved stakeholders.”
The Food and Drug Administration has been taking a closer look at how to best integrate real-world data into its regulatory decisions. Two years ago, the agency issued a guidance, noting that this was a “top strategic priority.”
While the FDA had already built up efforts to monitor drugs after approval, it in some cases might consider using real-world evidence to support post-approval study requirements or to support new indications for approved drugs.
More recently, a group of analytics companies banded together to form the RWE Alliance, which is pushing for clarity on when real-world evidence can be used in support of or in lieu of clinical trial data to support approval of new treatments.
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