Rethinking Clinical Trial Efficiency Amidst Cost Pressures on Pharma

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration's ‘Most Favored Nation’ pricing policy for pharmaceuticals, which aims to match the lowest global prices to reduce costs in the US. Based on his past experience at Eli Lilly, Kremidas expressed concerns about the policy’s impact on pharma companies' clinical development and NIH funding, which could lead to reduced investment in new therapies. Kremidas also highlighted the potential of multisite clinical research corporations (MCRCs) and how they can streamline clinical operations by consolidating contracts and improving efficiency.

ACT: We’re seeing increased financial pressure on pharmaceutical sponsors. Where do you think they'll look first to find cost efficiencies, and how do clinical trials fit into that equation?

Kremidas: There's two major areas, if you will, that a pharma company can look at. One would be in their sales and marketing or the commercialization of the products that they currently have available. I'm sure there are ways to cut costs there. I'm not going to go into that, because I think this audience is really more interested on the research and development side of the equation. As I mentioned earlier, it's going to have an impact in terms of the approach that pharma companies take to developing new drugs. Again, the area of the research side, so pre-clinical there's probably opportunities there to cut costs. I don't know if that's good or bad, probably bad, but on the clinical development side, we think that there are opportunities to reduce the costs of development. Now, a lot of effort these days is going into using new technologies in order to do that, for example, artificial intelligence and some of these other tools. One of the things that that we feel is important is to understand that the development of these of products, as you get through Phase I, II, and III for submission, technology helps, but at the end of the day, it's people who administer these studies. There are people that manage the studies, the site staff, the pharma company staff, the CRO staff, so there's going to be an awful lot—we believe—of opportunity to improve on the inefficiencies that currently exist from the way things are currently structured, in the way that we develop drugs, Phase I-III at this point in time.