Synergies From Integrating Randomized Controlled Trials and Real-World Data Analyses

Abstract

Analyses using administrative claims databases or national registries provide estimates of benefits and harms of medications in real-world settings for large and diverse patient populations. Whereas claims-based nonrandomized studies and randomized-controlled trials (RCTs) have distinct limitations, their strengths are complementary. Integrating RCT and claims data offers substantial synergies. We propose obtaining routinely collected longitudinal claims data from RCT participants and discuss the added value of the novel evidence that can be derived from this "information overlap."