Abstract
The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential in utilising real-world data in designing clinical trials. This article intro duces real-world data and presents a few considerations for designing non randomised single-arm clinical trials and observational studies that include this design element.1,2
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