Synthetic Control Arm^®: The Smart External Control Arm Solution

While randomized controlled trials (RCTs) remain the gold standard for evaluating the safety and efficacy of experimental therapies, there are circumstances in which maintaining a concurrent control arm is neither appropriate nor feasible. In these situations, generating the evidence needed to interpret and contextualize trial results can be challenging, potentially hindering decision-making, causing costly delays, and putting the trial at risk.

An external control arm (ECA) — a control group constructed using data from patients outside the current trial — is a powerful tool that enables researchers to evaluate the efficacy of a novel treatment and generate scientifically rigorous evidence. This evidence can inform internal decision-making, support regulatory discussions, and facilitate market access.