Redefining Collaboration in Clinical Trials: How Sponsors, CROs, and Sites Can Align

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: Looking forward in this landscape of uncertainty with budget cuts and administrative shifts, how can key stakeholders in clinical research better collaborate to support both innovation and affordability?

Kremidas: I think first and foremost, one of the most important things is communication and transparency. If you think about MCRCs or just sites in general, they're sort of at the end of the line, if you will, so you have the sponsor developing the protocol. In many, many cases, the CRO executing that protocol from a management perspective, and then, of course, the sites executing the protocol in terms of dealing with the patients and collecting the data. Often, again, in the past, what has happened is the protocol gets developed, it’s thrown over the fence to the CRO, the CRO then throws it over the fence to the sites, and there's not an ongoing communication during the development and execution of that protocol. That's not to say there aren't examples where it happens. I don't want to imply that, but I think there are plenty of opportunities to be more engaged from the beginning of the design of the protocol, both with the CRO and with the sites, as well as through the execution of how that then gets put into place from an operational perspective, so that's one area.

Along with that—still with transparency, communication—as things are ongoing, getting information back from sites about what are the experiences with collecting the data and engaging the patients, etc. The other thing I think that is important is the whole idea of training. If you look again at the traditional site training model, each site is trained differently, and it might be by different CRA, so you're going to get inconsistency. One of the things I learned when I was deeply involved with Six Sigma is the more variance you have, the higher the probability that you're going to have errors or inconsistencies, so the idea is, the more you can be consistent, and the fewer people involved in doing the training, and the more standardized the training is, the better quality you're going to get from an execution standpoint, so that's an area.

Finally, there's a whole idea of shared risk models. I think over time, we're going to see the MCRCs partnering with pharma companies and with CROs. In fact, with CROs, as you're probably aware, some CROs already own their own MCRCs, so they're seeing the vertical integration as an opportunity. We see it the same way. We think that the vertical integration of the sponsor, to the CRO, to the sites, or from the sponsor directly to the sites, is a huge opportunity. There may be ways to share the risk of the development of a particular product or the execution of a particular protocol.