The clinical trial sponsor companies have used real-world data (RWD) for years to generate evidence after their therapy is approved. Can they also use it to prove safety and efficacy during clinical trials? Mounting evidence shows external control arms, which use data collected outside of the current trial, can augment traditional control groups when the standard approach isn’t feasible. In some cases, an external control arm may even replace the traditional control group.

To get the insights needed from both your internal and external controls, external data must integrate and harmonize with clinical data. Traditional point-solutions such as EDCs lack the capability to integrate diverse data sources and deliver the robust analytics needed for effective clinical research. Before we delve into clinical systems, let’s take a step back and explore why you would need an external control arm and the advantages of taking this route.