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: In your view, what are the biggest inefficiencies in traditional clinical trial operations today that MCRCs are well-positioned to solve?
Kremidas: If you look at the way that we go about working with investigator sites in today’s environment, from a historical perspective, the approach has always been, you write a protocol, you take that protocol, and you begin to go out and talk to different investigator sites. “Hey, can you do this that you know your feasibility assessment? Do you have the capabilities? Do you have the right skill sets? Do you have the patient populations, etc.?” Now that approach is quite slow and tedious, if you will. Sometimes the sites are overwhelmed. They don’t really want the study. Other times they would like to study, but maybe they’re not the best site to actually conduct that study, so one of the things that we’re excited about with the MCRCs, and that AMRC is trying to help people understand is that you can contract with an MCRC and get a number of sites all at once. Let me give you an example. Let’s assume you have a study and you figure you need 40 sites. Now, we’re not saying go to one MCRC and get 40 sites from that organization, but we are suggesting, instead of going one site at a time, why not go to two or three MCRCs, maybe you sign up 10 sites from one, 10 sites from another, and maybe 10 sites from a third, or maybe you get 15 from two of the MCRCs. You now sign two contracts, instead of 30 contracts. You now train twice instead of 30 times for the staff. You get consistent contracting, you get consistent feasibility assessments, you get consistent specialized support as it relates to technology, data management, queries, whatever it happens to be. Now you’ve got 30 sites out of 40. Fill in the other 10 with whatever else you need. If there’s a location where you feel like there’s a patient population you really would like to engage in the study, or if you want academic sites engaged in the study, then you can fill in the blanks. Historically, though, we go one at a time, which takes much longer than if you were to sign, in this case, you would be signing 12 contracts instead of 40 contracts. You see my point? That’s one area. Just the startup timelines would be significantly faster, and indeed, there was a publication recently, in Applied Clinical Trials in February that looked at the startup timelines for dedicated sites compared to the traditional sites, and indeed, it was much quicker. By the way, there’s other data that was published in DIA last year that shows that the enrollment rates are about twice as fast with MCRCs as with traditional sites, so there’s another area. Patient recruitment tends to go much more rapidly when you’re using MCRC. There you have two elements that drive a much faster turnaround time for your study.