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Generating real-world tumor burden endpoints from EHR real-world data


May 2019


Griffith SD, Tucker MG, Bowser B, Calkins G, Chang C, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA. Generating real-world tumor burden endpoints from electronic health record data: Comparison of RECIST, radiology-anchored, and clinician-anchored approaches for abstracting real-world progression in non-small cell lung cancer. Adv Ther. 2019;36 (8):2122-2136.

Our summary

In collaboration with the FDA, Dana-Farber Cancer Institute and Genentech, Flatiron evaluated methods to capture progression outcomes based on the documents in the electronic health record. This study found that the application of strict RECIST clinical trial radiology interpretation rules was not viable; however, capturing the clinician’s written assessment of the patient’s cancer status was a feasible and reliable method for understanding progression.

Why this matters

The analysis of oncology RWD requires a full analytical armamentarium of methods and endpoints tailored to the data as collected during routine care. This study presents a novel approach to identify disease progression events from information contained in patient charts, therefore enabling analyses of progression-free survival and time -to -progression outcomes in EHR-derived real-world datasets.

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