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# FDA, Flatiron Health Real-world Data Pact
- URL: https://www.fdaweb.com/fda-flatiron-health-real-world-data-pact/
- Published: 2023-09-06T12:00:00.000Z
- Updated: 2026-09-14T18:54:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155259

FDA’s Oncology Center of Excellence and Flatiron Health have renewed a five-year collaboration to jointly develop and implement specific research projects to advance real-world data (RWD) use and explore strengths and limitations with using real-world evidence (RWE) for regulatory purposes. “The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer,” Flatiron Health says.

The company says that other projects under the collaboration will “explore approaches to define and assess fit-for-purpose relevant data on treatment exposure, patient outcomes, and covariates required to answer specific questions of interest. As part of the research process, Flatiron’s datasets will be analyzed to explore fit-for-purpose RWD, create real-world study protocols using best pharmacoepidemiology practices, and conduct observational studies.”

Additionally, it says, the research pact will allow Flatiron to provide FDA access to its datasets/platform, and highlight its suite of services, including cutting-edge analytics, scientific expertise, and strategic consulting.