2025 Trends: Leveraging Data Standards

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.

ACT: What do you think should be top of mind for clinical operations executives going in 2025?

Tableman: I think there's a number of different things, but I think the data interoperability part that I just spoke of, and leveraging the standards, again, from the ICH M11 all the way through enabling that digital data flow, but what it really empowers again, is artificial intelligence. We are seeing the use of AI, and we talk a lot right now about artificial intelligence with a human in the loop, so I think for where we're at right now in pharma, I think that clinical operations executives need to be looking at it, but I think also realizing that we're not yet at the advent where artificial intelligence is taking away jobs and so on and so forth, you still need people that are looking at what the AI generates and saying, “Yeah, this works, or it doesn't work.” For us, for example, we use artificial intelligence to bring in a bolus of objectives, endpoints, inclusion/exclusion, criteria, that are options that you can put into the protocol, but a human being is still looking at that information and making a decision about, “Yeah, I want to leverage this objective or this endpoint, I want to put in this inclusion or exclusion into the study design overall.” I think getting comfortable with a trust but verify, taking some steps in that direction, to start getting more comfortable with artificial intelligence will be really helpful.