Integrating Trials into Routine Care

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: McKinsey notes trials may increasingly integrate into routine care. How will this change how clinops teams design and manage studies?

Agrawal: Yeah, this is, this is, we feel, a very important factor. And I think if I, if I step back and look today, if I take oncology as an example, more than 80% of patients in regular clinical care settings get treated at hospitals that are in different regions and communities, and what I would call not the AMCs, so only 20% of the people are actually being taken care of at the AMCs, or even fewer.

But if you look at our clinical trial footprint across the industry, more than 85% of the footprint of clinical trials is actually in AMCs, academic medical centers. And I think that disparity between where irregular clinical care happens and where clinical trials are happening, I think over a period of time if we have to get more patients into the right set of clinical trials, we will have to bridge that gap between where clinical care is happening and where trials are happening.

And so in line with this, I think this is probably one of the biggest shifts that a lot of companies will have to think about, how can they play their part in the overall ecosystem, and this includes everything from, you know, using AI and data to look at where are, where are we finding people in terms of, you know, access, in terms of diversity, etc.

But also, more importantly, actually being able to use AI to be or sort of, sort of, even if you leave AI aside, being able to go to what I call trial-naive sites, which haven't experienced clinical trials, and being able to appropriately handhold them to bring them up to a standard that they do get interested in clinical studies.

I think, on the other hand, companies will also need to look at simplifying their clinical trial protocols, because if the protocols are extremely complex and only administrable at some of the more sophisticated hospital settings, care settings, I think it's naturally going to restrict the footprint. And I think this is the second area that clinical teams will need to think about—their protocols that can be more democratized throughout sort of the ecosystem of clinical care settings, including in community settings.