Expanding The Role Of External Control Arms

External control arms (ECAs) are reshaping clinical trial design by providing an efficient, ethical alternative to traditional control groups, especially in contexts where placebo or non-interventional arms are impractical or controversial. By leveraging real-world data (RWD) to generate real-world evidence (RWE), ECAs can reduce trial costs, shorten timelines, and improve patient-centeredness without compromising scientific rigor.

This paper explores the strategic advantages of ECAs, particularly in rare disease and oncology trials, where patient recruitment poses substantial challenges. Despite limitations—such as missing or non-standardized data—advancements in data curation, like Verana Health’s Qdata®, are helping mitigate these risks and align ECAs with regulatory expectations. ECAs can also enhance clinical trial diversity by incorporating data from broader demographics often underrepresented in randomized controlled trials (RCTs). With growing regulatory support and technological advancements in AI-driven data processing, ECAs are poised to play a transformative role in accelerating the development and approval of innovative therapies. Verana Health stands out as a leader in enabling this transition by providing robust, fit-for-purpose datasets and tools that meet the demands of modern clinical research.