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.