2025 Trends: Leveraging Real-World Data for Synthetic Control Arms

In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical research industry could see in 2025. Jadhav highlighted how unstructured data like physician notes and imaging data can be leveraged to improve disease identification and progression tracking. He also talked synthetic control arms and how they can replace expensive non-treatment arms, enhancing trial efficiency.

ACT: What trends do you think we’ll see in 2025 with real-world evidence (RWE) and real-world data (RWD) in clinical research?

Jadhav: The second bucket is around external control arms, synthetic control arms. It's been around for quite a while, overarching use of this for the particular components of the clinical trial where they're actually not getting the treatment, so the non-treatment arms are leveraging real-world data to understand and compare and contrast to the treatment arms that you put forward there. Historically, recruiting patients where you're not providing them the treatment, as you can imagine, is very, very expensive and very time consuming overall. I think that's the area where you look at synthetic control arms, and leveraging real-world data can help be a good proxy, or can help augment and allow you to compare and contrast to the treatment arm. The good thing with real-world data and leveraging it for these type of control arms is that the volume is very, very large, and the quality and the longitudinality of the data is pretty good as well. If anything, the compare and contrast, the treatment arm versus a non-treatment arm can actually be a high-quality fashion as well. These are some of the key trends that we're seeing as we move into 2025 in terms of helping improve clinical research by leveraging real-world data.