The FDA has renewed and expanded its real-world cancer data collaboration with Flatiron Health for another two years, to continue its work into the validation of related clinical endpoints and development of real-world control arms.

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 not provide sufficient follow-up to truly understand the impact of a new therapy on real-world patients," said the FDA’s Richard Pazdur, director of the agency’s Oncology Center of Excellence.

"We believe that regulatory-grade real-world data can help inform our decisionmaking so that we can provide cancer patients with better care," Pazdur added. Flatiron and the FDA also plan to evaluate cancer populations that are typically under-represented in clinical trials.

The collaboration began with Flatiron—a part of Roche since February 2018—providing deidentified data from patients with advanced non-small cell lung cancer who were being treated with immunotherapy, for outcomes research into progression, tumor response and therapy discontinuations.

Going forward, Flatiron also plans to work with the FDA through its own partners in the life sciences industry, as more drugmakers come to the agency with real-world evidence incorporated in their regulatory filings for postmarket studies and label expansions.

"In order for the entire industry to benefit from RWE, we must ensure that our datasets are comprehensive and of the highest-quality," said Flatiron Health Co-Founder and President Zach Weinberg. "Working with the FDA enables Flatiron to both learn from their leadership and continue to contribute to standards development."

Last December, the FDA brought on Flatiron’s chief medical and scientific officer, Amy Abernethy, to serve as its principal deputy commissioner of food and drugs. She takes over for long-time agency leader Rachel Sherman, who retired this year after holding a variety of roles at the FDA since 1989.

In a letter to colleagues announcing the decision, FDA Commissioner Scott Gottlieb described Abernethy as a "highly regarded thought leader" in real-world evidence generation and clinical trial efficiency.

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