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FDA and Flatiron Health Expand Real-World Data Cancer Research Collaboration

February 25, 2019 / Alex Keown

Roche’s Flatiron Health and the U.S. Food and Drug Administration (FDA)’s Information Exchange and Data Transformation (INFORMED) Program expanded a two-year-old collaboration agreement. The agreement, forged in 2016, has enabled the regulatory agency to gain a better understanding of how real-world-evidence derived from de-identified patient datasets curated from electronic health records, can support regulatory decision-making. Since the agreement was first struck, the FDA and Flatiron have explored the use of real-world evidence to generate insights into cancer treatment trends and clinical outcomes in the United States.
Under terms of the expanded agreement between Flatiron and the regulatory agency, they will focus on critical topics related to the use of real-world evidence in regulatory decision-making, including characterization of data quality, validation of reliable real-world clinical endpoints, collaboration on new analytic methodologies and exploration o...