Flatiron, FDA extend cancer data research collaboration  

The FDA extended its cancer research agreement with Flatiron Health, an oncology EHR vendor that Swiss pharmaceutical company Roche acquired in 2018.

The FDA-Flatiron partnership, which began in 2016, aims to enhance the FDA Information Exchange and Data Transformation Program's understanding of how real-world evidence, derived from de-identified patient datasets, can support regulatory decision-making.

During the new two-year expansion, Flatiron and the FDA will research real-world cancer populations that are typically underrepresented in clinical trials. The organizations also plan to continue focusing their efforts on the use of real-world evidence in regulatory decision making, including characterization of data quality and validation of real-world clinical endpoints.

Over the past two years, the collaboration has produced various peer-reviewed articles, including a study in The Oncologist on real-world outcomes of immunotherapy treatments for cancer patients with advanced non-small cell lung cancer.

"The FDA recognizes the tremendous importance of analyzing treatment data from the real world," Richard Pazdur, MD, director of FDA's Oncology Center of Excellence, said in a news release. "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 not provide sufficient follow-up to truly understand the impact of a new therapy on real-world patients. We believe that regulatory-grade real-world data can help inform our decision-making so that we can provide cancer patients with better care."

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