Flatiron Health expands real-world cancer data collaboration with FDA

First launched in 2016, Flatiron’s partnership with the FDA’s Information Exchange and Data Transformation program, or INFORMED, has worked to apply anonymized datasets from electronic health records in regulatory decisionmaking, focused on cancer treatment trends and outcomes.

“Traditional clinical trials have long provided the high-quality evidence the FDA needs to determine whether a product is safe and effective for its intended use, but traditional trials do not always represent the real world, lack clinical context, and may...