Using Real-World Data to Enhance Clinical Trials

James Richard Rogers

Clinical trials are generally considered the foremost authority for generating robust medical evidence because of their methodological strengths relative to other clinical research designs. However, they are susceptible to substantial challenges, such as enrollment barriers, low participation rates, high operational costs, and limited results generalizability, to name a few. A promising resource to address these challenges is real-world data (RWD), generally defined as routinely collected data during the delivery of healthcare. Database-specific RWD – such as electronic health records (EHRs), administrative claims, and clinical registries – is of particular interest for their richness and volume. However, coordination between the primary data collection actions of clinical trials with the secondary collection nature of RWD, while also accounting for data fitness-for-use...