Flatiron Health is teaming up with the Food and Drug Administration (FDA) to research the real applications and effectiveness of various immunotherapies. This collaboration aims to evaluate patient data collected outside of clinical trials to provide new insights that could benefit patients with cancer.
The first component of the collaboration focuses on use of immunotherapy among patients with advanced non–small cell lung cancer.
As few as 4% of patients with cancer are represented in clinical trials. Thus, clinicians must recommend treatments for their patients based on safety and efficacy data that only reflect a small proportion of the population.
“Through this research collaboration, we can augment our understanding of the safety and effectiveness of lung cancer therapies outside of clinical trials, in a manner consistent with supporting a learning health system where new knowledge and discovery can be byproducts of the health care delivery experience,” Kristofer Baumgartner, a spokesman for the FDA, told HemOnc Today. “This collaboration is part of an organized effort by the Office of Hematology and Oncology Products to proactively investigate the utility of novel pipelines of data — such as real-world data from electronic health records — in advancing regulatory science.”
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