FDA Taps Flatiron for 5-Year Real-World Data Collaboration

What You Should Know:

• Flatiron Health today announced its renewed collaboration with the Oncology Center of Excellence (OCE) of FDA to jointly develop and implement specific research projects to advance the use of Real World Data (RWD) and explore the potential strengths and limitations of 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.

New Collaboration to Broaden Horizon for Clinically Meaningful Medical Research 

“Flatiron is honored to further our collaboration with FDA,” said Javier Jimenez, Chief Medical Officer, Flatiron Health. “Flatiron and FDA will collaborate to explore the potential strengths and limitations of using real-world evidence through investigations of a broad set of research questions regarding the care and clinical outcomes of patients diagnosed with solid tumors and hematological malignancies.”

Further, projects under this 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, the collaboration will enable Flatiron to provide FDA access to their  datasets/platform, and highlight their suite of services, including cutting-edge analytics, scientific expertise, and strategic consulting.

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