ACT: Another topic we’ve heard a lot about recently is relationship building between CROs, sponsors, and sites. Why is this so important and what are some best practices for building these relationships?
Bechtel: Absolutely, it’s a good question, and one we talk about a lot actually with SCRS and our partners, because it’s kind of foundational in a way that’s critical to the successful execution of clinical trials long-term and building relationships. There’s so many benefits that can come out of appropriately-built relationships, and so many of the issues that we see, even the one that I just spoke about with technology, can be at least moved in the right direction, if not solved by building effective relationships and communication. Even examples of your personal life and failing at relationships in your personal life, a lot of it can be traced back to poor communication, so asking and having that discussion early on in that relationship, checking in with each other on how to communicate, and developing and sticking to a communication plan is a really great way to build a relationship, and I think there’s a couple of important components to that. It doesn’t really help to create a communication plan, or establish that understanding if you don’t use it or stick to it, so that’s a really important part. Coupled with that is reapproaching that communication plan, because you’re going to probably work with a completely different team at a given organization, so just because a communication plan worked on one trial doesn’t mean that it’s going to work on the next trial, or it might need some modifications, or again, just revisiting it is healthy for any relationship that you’re trying to build. Part of that, I would say also, is being as transparent and honest as possible. If we can start to break down some of those barriers and stop treating the relationship as ‘us and them’ and more of ‘we,’ it sounds cliche, but it’s still happening. We’re still kind of holding our cards pretty tight to our chests and not helping each other understand, “Yeah, I am struggling as a site. Yeah, this isn’t easy. This screen failure is a challenge for me. I’m not going to be able to meet those enrollment numbers” or from a sponsor, “Yeah, if you ask for that, we probably can approve it or, no, we’re not going to be able to improve it for these reasons or maybe if you asked it in a different way, we might be able to approach that or consider it, or get approval for it.” So stop treating it like this hidden relationship and again, as you heard from my examples, it goes both ways. There’s work to be done there by the site—just like any relationship, professionally or personally—the sites have to come to the table as well as the sponsors and CROs have to come to the table to build those effective relationships and they take work. It’s not just something that you can establish at the beginning and expect it to—over the course of a couple of years—as many clinical trials go, work without a hitch.