Flatiron Health enters new five-year research collaboration with FDA on real-world data
Flatiron Health has unveiled its renewed partnership with the Oncology Center of Excellence (OCE) within the United States Food and Drug Administration (FDA). This collaborative effort is focused on jointly conceiving and executing specific research initiatives aimed at advancing the utilisation of real-world data (RWD) while delving into the potential merits and limitations of employing real-world evidence (RWE) for regulatory purposes.
The alliance will, in particular, scrutinise RWD study designs and analytical methodologies through a concerted effort to formulate essential, clinically significant research inquiries regarding the care, treatment, and outcomes of patients afflicted by cancer.
Javier Jimenez, Chief Medical Officer at Flatiron Health, expressed their appreciation for the continued collaboration with the FDA, stating, "Flatiron is honoured to continue our collaboration with FDA. Together we will 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 tumours and haematological malignancies."
Moreover, the projects stemming from this partnership will delve into strategies for defining and evaluating pertinent data suitable for addressing specific queries regarding treatment exposure, patient outcomes, and relevant covariates. As an integral part of this research endeavour, Flatiron's datasets will undergo comprehensive analysis to ascertain their suitability as RWD, establish real-world study protocols based on the best practices in pharmacoepidemiology, and conduct observational studies.
In addition, this collaboration will empower Flatiron to grant the FDA access to their datasets and platform, highlighting their array of services, including cutting-edge analytics, scientific expertise, and strategic consultancy.
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