Association of Patient Characteristics and Tumor Genomics With Clinical Outcomes Among Patients With Non–Small Cell Lung Cancer Using a Clinicogenomic Database

Abstract

The passage of the US Food and Drug Administration’s Breakthrough Designation Act in 2012 and development of targeted therapeutics for patients with cancer have accelerated access to life-prolonging and, in some cases, curative medications, often based on substantial effect sizes seen in smaller, earlier-phase clinical trials.¹ In 2016, the 21st Century Cures Act recognized the need for “real-world evidence” to further establish the benefit of these agents, understand their optimal use, and inform future trial design.² Population-based, research-grade, linked clinicogenomic data sets generated from routine clinical care could significantly accelerate the advancement of clinical practice and the development of novel therapeutics.