Flatiron Health Research Characterizes Real-World Response & Associated Endpoint in Oncology
Flatiron Health has announced the publication of research showing that curation of de-identified electronic health record (EHR)-derived data can be used to generate a reliable real-world response (rwR) variable and associated endpoint in oncology.
Real-world treatment effectiveness measures are needed to generate real-world evidence (RWE) that may support development and regulatory decision-making. For this work, Flatiron researchers leveraged the clinical interpretation of radiographic assessments of solid tumor burden, as documented by clinicians in an EHR, to develop an rwR variable, and have evaluated its clinical relevance. “Characterization of a real-world response variable and comparison with RECIST-based response rates from clinical trials in advanced NSCLC,” published in Advances in Therapy, indicates that rwR is clinically meaningful information that may be considered a real-world measure of treatment effectiveness.
“This work could help address such questions as how cancer medicines are working for patients in the real world, providing meaningful insights for patient care and outcomes. Similar uses could inform cancer drug development decisions,” said Michael Vasconcelles, Flatiron’s Chief Medical Officer. “This research is an important step toward realizing the potential of data collected as part of routine clinical care, and strengthens the foundation to frame the next questions in real-world endpoints research.”
This paper marks a milestone in Flatiron’s continuing commitment to real-world endpoints research (previously published papers are linked here), including its collaborations with groups such as Friends of Cancer Research (FOCR) and the Duke Margolis Center for Health Policy. Future investigations are needed to evaluate patient-level concordance between real-world and RECIST-based endpoints, and to understand the generalizability of these results across oncology.
Flatiron Health is a healthtech company dedicated to helping cancer centers thrive and deliver better care for patients today and tomorrow. Through clinical and data science, we translate patient experiences into real-world evidence to improve treatment, inform policy, and advance research. Cancer is smart. Together, we can be smarter. Flatiron Health is an independent affiliate of the Roche Group. Flatiron.com @FlatironHealth