NEW YORK (GenomeWeb) – Flatiron Health announced today that it has signed a research deal with the US Food and Drug Administration to determine how real-world evidence derived from patient data captured outside of clinical trials can provide insights into the safety and efficacy of new anti-cancer therapies.
"With only four percent of the adult US cancer population enrolled in clinical trials, we as providers are currently limited to making clinical decisions based upon study results that represent only a small number of patients," Flatiron Chief Medical Officer Amy Abernethy said in a statement. "This makes it nearly impossible to estimate whether a treatment will work, anticipate all of the potential side effects of therapies, or even decide which treatment should precede another."
Under the terms of the deal, Flatiron and the FDA's Center for Drug Evaluation and Research will start by using de-identified, HIPPA-compliant data from patients with advanced non-small cell lung cancer who are receiving immunotherapy to explore analytic approaches, clinically relevant endpoints, and safety assessment methods.
"Collaborative projects such as this one with the FDA allow us to access real-world evidence for more accurate and actionable insights into patient care and expected outcomes outside of clinical trials, supporting the delivery of high quality patient care," Abernethy added.