Accelerating Drug Development With External 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: How can external control arms (ECAs) accelerate drug development?

Jadhav: There's a number of areas in terms of how external control arms can accelerate drug development. As I mentioned, the biggest advantage is when you're looking at the non-treatment arms and then the costs associated with recruiting patients is pretty sizable, and that's really where you can plug in real-world data to help be a better proxy, or help bolster that part to allow you to compare and contrast. Some of the areas where control arms can accelerate drug development, one is addressing ethical dilemmas. When you look at ECAs, they eliminate the need to randomize patients into non-interventional groups, particularly in studies where a placebo or a standard of care may be ethically questionable.

Another area is utilizing existing data, so what we find is in rare diseases with small patient populations, external control arms allow researchers to use historical, real-world data to make studies more feasible and more inclusive. As you can imagine, without external control arms, going through and recruiting enough patients, which can be a good comparison there as well in rare disease areas, is very, very difficult to do, and that's where real-world data can shine quite well.

There's a quality element in terms of how external control arms can help, so providing high quality insights by creating reliable comparison groups that can really help reduce the reliance on traditional non-interventional groups, or maintaining robust scientific validity there as well. What we are seeing, again, is the theme of going after the unstructured data to help improve these high-quality insights. With technology we have today with helping ingest data in a more efficient fashion than historically has been as well, that allows you to bring in a lot of this unstructured data and provide insights in a very timely fashion, which historically has been very difficult to do. Fundamentally, I think when you look at external control arms, they accelerate the overall therapy development, and these methods help streamline the clinical trial process, enabling faster development and effective therapies without actually compromising scientific integrity.