Using Digital Tools to Enhance Patient-Centric Trials

In a recent video interview with Applied Clinical Trials, Gaurav Agrawal, Senior Partner at McKinsey & Company, highlighted insights from the company’s new report on clinical operations. Agrawal outlined how AI can accelerate development timelines by optimizing trial design, reducing operational “white space” between phases, and streamlining study startup, monitoring, and closeout activities. He emphasized the value of human-AI collaboration, noting that AI provides insights for protocol design, site selection, and monitoring while humans contribute strategic oversight and relationship management. Agrawal also highlighted the growing need to integrate trials into routine care and expand access through trial-naive sites and simplified protocols, as well as the role of digital tools in decentralizing assessments and enhancing patient-centricity. Looking ahead, he stressed that preparing for end-to-end AI-enabled trials will require systematic adoption of technology, cultural and workflow transformation, and cultivating digitally savvy clinical operations talent.

The below interview transcript was lightly edited for clarity.

ACT: The report points to digital tools expanding access and diversity. How can clinops use these tools to make trials more patient-centric?

Agrawal: Yeah, I think, look, this has been a focus for most of the companies for a long time. And I think the question is, how do we continue expanding this rapid journey? And I think there's a couple of things that come to mind.

One, I think, as I was starting to mention, how do we use data that's out there? And that's everything to do with demographic data, everything to do with claims data that have pretty wide and broad coverage in terms of patients, their sort of status and where they live, et cetera. And being able to mine that data to say, where should we set up clinical trial sites, and where should we go for our clinical trials so that we recruit appropriately broad set of populations that are more representative and able to provide access to patients who otherwise wouldn't have access to just the, you know, eight or 10 big cities, if you will. That's sort of number one.

Number two is incorporating some of the digital tools in your protocol in a way that it democratizes where these trials are done. So, you know, we did an analysis back during COVID days when we looked at sort of protocols and said, how 100% of these assessments and visits today are at the sort of center where the clinical trial is being held. What part of this clinical trial can you actually make sure you collect through remote visits, through wearables, through other digital technologies, through ePROs that allow you to collect at least some amount of information and reduce the burden of patients having to travel far to these clinical trials.

And so you still need an anchor site where patients would travel. But can you actually make sure instead of 20 visits, they have only 12 visits, and the assessments for the other eight visits are being done remotely, either closer to their home and or through supplemented digital means? And I think this is sort of the second step of what companies will have to think through, which is, how do we appropriately incorporate digital technology into protocols for measurements that allow for more remote ability to measure things, and hence, sort of spread the geographic area or catchment area of where these trials can happen.