2025 Trends: Advancements in Data Interoperability

In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical trials. She also highlighted technological advancements, such as data interoperability standards like ICH M11 and CDISC, and how they are expected to streamline protocol development and support generative AI in 2025.

Tableman: I think one of the things we're really seeing right now is related to data interoperability, so we have historically had a set of data standards, particularly getting data submission ready from a CDISC perspective, but we have also now seen with the FDA putting forth the guidance on the ICH M11 standardization around the data for protocol collection as well, so that data, and then there's an opportunity, really, from an interoperability perspective, to map all the way through, so you have the protocol now in the ICH M11 format, you can map that to CDISC. We've done that as well as USDM, and we have for the schedule of activities, mapped all the way through to this, to the actual SOA itself, so the ability to then, from a FHIR perspective, be able to share that data, which this has all been things that the industry has been talking about for a number of years, and it is now finally coming to fruition. The benefit of that data interoperability is supporting generative AI. It's really allowing you to use data in downstream systems to really automate that digital data flow. Again, stuff that we've been talking about but haven't really been able to fully recognize, I think we're going to see that happen in 2025.