The startup will work with the FDA to evaluate the efficacy and safety of current cancer treatments in different groups of cancer patients.
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.