NEW YORK, NY
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.
About Flatiron Health
Flatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group.
