How CRO Partnerships Are Evolving to Meet Changing Industry Demands

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline CRO Partnership of the Year Award in recognition of its partnership with Tune Therapeutics. Ng-Cashin highlighted the importance of seamless, trusting relationships in clinical research, as well as the roles of cost efficiency, risk-based approaches, and leveraging CRO expertise to navigate partnerships in the evolving regulatory landscape.

ACT: Considering the evolving landscape of clinical research, how do you envision the role of CRO partnerships changing in the next few years?

Ng-Cashin: I think we're already starting to see that. Depending on the type of sponsor and the type of CRO I'll start with what I'm living at the moment with being a mid-sized CRO servicing biotech. Funding is tight. People are looking for cost efficiencies. People are looking to their CRO partner to not just drive cost for our own enrichment, but to really get in the trenches and understand where—for instance, looking at a risk based approach—where can we spend a little less so that we can save our resources for the things that we think are going to be most complex, the endpoints we think are going to be the most valuable, whether it's to the regulators or whether it's to the investors for the next raise, etc. I think partnership around how to best deploy capital against these studies will be important.

For a different sort of situation where it's a bigger CRO and a bigger sponsor, I think pooling the resources. A lot of times, in my experience, there's duplication of function in the sponsor and the CRO when you're talking about larger organizations. I think coming to the table, being honest about who is going to do what. If you're on the sponsor side, how much double checking or oversight is appropriate? Not to say that we don't need oversight across partnerships like these, they're complex. However, don't confuse partnership with duplication and redundancy. I think that drives efficiency, not only in cost, but also in speed. I think that's really where people are focused, as well as where we've always been, data integrity. It's an evolving regulatory landscape. You're trying to understand what's acceptable now with this, that, or the other health authority, you're trying to anticipate what you think is going to be okay as health authorities evolve. I wish that weren't political, but it is, so trying to see ahead, I think where sponsors can leverage their CRO partners is, as a sponsor, maybe you're doing one Phase III trial in a particular indication per year to five years, your CRO partner might be doing three right now. What are the insights they're seeing about how the regulators are reacting to those designs, those data, etc. I think just the acknowledgement that the different sizes know different things, and we should bring all that knowledge to bear as we go forward in uncertain times.