The Site Factor: Where Protocol Meets Real-World Practice in Clinical Trials

Clinical trials are innovating fast, but what happens when new tools, models, and processes are layered onto sites without alignment? In this episode, Stacey Davidson, Head of Content and Strategy at Cuttsy+Cuttsy, joins us to unpack The Site Factor, a report built on insights from 100 site staff across the globe. Stacey shares what sites revealed about recruitment challenges, communication gaps with sponsors and CROs, and why 86% of site staff say additional communication training would be valuable. From the operational frictions that quietly drive patient dropout to the feedback loops that don't exist yet, this conversation highlights where small changes can make a big impact. Because when we protect the site experience, we protect the participant experience too.

Download The Site Factor here: https://www.cuttsyandcuttsy.com/the-site-factor-report

Transcript

Lauren Stockwell: 0:00

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Lauren Stockwell, education and Engagement Manager with SCRS. I'm joined today by Stacey Davidson, head of Content and Strategy with Cuttsy and Cuttsy. I'm so excited to talk all about their entire site report that they have really engaged with sites in order to create the site factor and the upcoming European Site Solutions Summit in Amsterdam this March. First and foremost, let me turn it over to Stacey, for anyone who hasn't read the report quite yet, what is the site factor?

Stacey Davidson: 0:43

Hi, Lauren. Well first of all, thank you so much for having me on your podcast, and I'm really looking forward to this conversation. So for anyone who hasn't yet read the report, please go and download it. We'll put some details, in the show notes so that you can access it. But it all stemmed for some previous research that we did at the end of last. Year, which was the participation equation where we started to look into what drives participants to move forward into clinical research. Through that research, we found that 75% of participants rated their clinical trial experience and eight out of 10 or higher. And the higher the experience score, the more likely they were to complete the study. Great news When we dug into that a bit more, what we really found was that at the heart of that experience was a single defining factor, and that was the perceived support communication, and organization of the site team. So. It was a natural progression to this next piece of research. this is where this report, the site factor, really shifts the focus to that interface to where protocol really meets real world practice and where we can listen directly to the people delivering those trials every single day.

Lauren Stockwell: 2:04

that's incredible, and I love that you're really focused on incorporating the voices that matter today and the voices that really matter in this entire process. In your opinion, why was it so important to do this report now and to really seek this information? I.

Stacey Davidson: 2:19

Because it really feels like the industry is at an inflection point right now. So we are really innovating rapidly. We are talking decentralization, new digital tools, new operational models, and they're all absolutely fantastic and really positive movements forward. But innovation layered onto complexity without prior alignment can really feel like an additional burden at site level. From what we've heard, and I say at the same time, we have this clear evidence that participant experience really drives completion. So the timing, it really matters.'cause if we are redesigning trials, we have to make sure that the people who are delivering them are really set up to succeed.

Lauren Stockwell: 3:06

yeah. And that's such an important aspect that SCRS constantly is looking to answer that question. If we can help set sites up for success, that will en turn set up clinical research for success. So as you were diving deep with, with these incredible participants that, that really contributed to this paper, into this document, what were some of the biggest challenges that site staff shared across the board?

Stacey Davidson: 3:30

Yeah, so we engaged with a hundred site staff across slightly different roles, and at a global scale as well. So we really wanted to get breadth as well as depth in our research. And what we found was that there was five key themes that emerged. So participant engagement, those recruitment challenges. Training and onboarding, patient facing materials and communication with sponsors. And what we really found and what struck me the most, I think, is just how interconnected they all are. Because actually picking those apart communication runs through all of it. So whether that's explaining risks to a participant, is clarifying eligibility with a sponsor, or, you know, even like navigating slot allocation, actually down at the detail, it all comes down to communication.

Lauren Stockwell: 4:25

Yeah, absolutely. And I think that that really leads me directly into my next question for you. I think communication is such a foundational portion of our industry, and if we don't have open visibility and we don't have open understanding, and I, and I truly appreciate how Cuttsy and Cuttsy took the time to, to pull these hundred different site representatives across, not just Europe, not just any sort of country or continent or anything along those lines, but really globally So I appreciate that you took the time and energy to make sure that your data was representative of the community as a whole. So why is human connection such a central theme to all of this? You know, as, as we go through and talk about communication, that is the human connection and that is a huge part of it. So I anticipated that that would be a theme. But, you know, in reading this report, I, it was absolutely apparent that that was such a central theme.

Stacey Davidson: 5:14

Yeah, absolutely. And as I sort of touched upon, our earlier research showed that those completion rates were really linked to the participant's relationship with their study team. But what we saw in that research was that even in an increasingly digital world, and even when trials were decentralized or hybrid visits on offer. Participants still really valued that human connection. So, you know, every answered question, every follow-up call, every moment of reassurance, it really shapes how supported someone feels through that process. And on flip side, in one of the, interviews we conducted for the site factor. Someone described how quickly frustration can really build if a participant feels like they're a number rather than a human, so someone looking after them and someone looking out for them. And who's invested in their care is so important. And thinking about what that looks like, it's, even the small delays, a call not returned very quickly. Confusion about a visit, they can all sort of chip away at confidence. So all that good work that we do to build trust and connection can really be undone in those moments.

Lauren Stockwell: 6:32

Mm-hmm.

Stacey Davidson: 6:32

And it's when that confidence drops that we see the retention rates suffer as well.

Lauren Stockwell: 6:37

Absolutely. And you know, if we can continue to push this narrative of ensuring that these patients feel like people and feel like humans and invested in, that's where we can really find that really wonderful retention rate. So, one of those standout statistics in the site factor specifically was around communication, training and, and really ensuring that we're setting these sites up for success inside of all of that. What, what do you feel that you learned in that process?

Stacey Davidson: 7:04

Yeah, so, so that standout stat that you refer to, I think that's the 86% of site staff told us that additional communication training would be really valuable. So it's not about clinical knowledge. It's actually about empathy, cultural awareness, how to explain complex science, clearly handling those difficult conversations really confidently. I think sometimes we underestimate how emotionally complex these conversations can really be. We are dealing with uncertainty, managing expectations, discussing side effects what to expect as you progress in this process, and really nuanced conversations. And I think expecting people to do that confidently without structured support is a really big ask. So actually that stat was so insightful.

Lauren Stockwell: 7:59

And you know, we expect these site staff members to, to wear so many hats in their day-to-day jobs, right? Not only are they entering data points and making sure that everything is accurate and you know, seeing patients, but they're also having to lean into their empathetic side and that lead into all of their. Cultural competencies. Right. You mentioned that. And I think that that's so important to recognize, let alone we're not even gonna bring in the technology side of things because that's a whole different hat rack that they have to put on, unfortunately. So making sure that we're equipping these site staff and, and these, these patient facing folks with the right competencies in that. You mentioned earlier one of the largest challenges that you saw was about recruitment and recruitment numbers in, in those lines. Like what, what did sites say about those recruitment challenges?

Stacey Davidson: 8:46

recruitment is, often framed as a, as a patient awareness issue. And we did see that around a quarter of our, participants in the research did cite that as the biggest barrier. But what we heard suggests that the biggest risk isn't actually awareness, it's attrition before enrollment. So you can have interest, you can have eligibility. And you can still lose someone because that pathway isn't seamless. So things like when slot allocation is unclear or when eligibility queries take time to resolve. And when those early conversations feel rushed, again, it's that confidence and we can see a drop in confidence happening. Recruitment can be really fragile, and it's those small operational frictions that can have really outsized defects. That's the the big takeaway that we were hearing through the research.

Lauren Stockwell: 9:43

Yeah, absolutely. And that's more in depthly highlighted through the site factor report, so be sure to make sure that you're reading through that and really understanding those recruitment challenges. So taking that a step further, how, how are site teams really experiencing communication with sponsors and CROs?

Stacey Davidson: 10:01

Yeah, it was something that was really fascinating to dig into and what we saw that were experiences were genuinely mixed. So 41% of sites described their relationships with sponsors as strong or very strong, so. It's important to say that there are good partnerships in place. But also what came through the research was just how much a communication load the coordinators in particular absorb. So almost three quarters of coordinators said that CRO only communication can cause delays. And that's because there's layers of complexity here. So. What we were told is when messages pass through multiple channels, we can see that clarity can start to suffer, and then that pressure lands back with the site team because they're the ones managing those participant expectations in real time while waiting for those answers to come. And then there's the feedback loop. So 25% of sites told us that they're never asked for feedback on sponsor provided materials. Coordinators are often the ones hearing directly from participants what's helpful, what they're finding confusing what they need a little bit of help with. So Actually there's a real kind of opportunity here as well. You need to tighten those feedback loops to streamline that communication so sites can feel kind of really aligned rather than overloaded.

Lauren Stockwell: 11:30

Yeah, absolutely. And for anyone listening on the line, I think that that's a challenge point and a key takeaway. Create opportunity for feedback loops. These sites are sitting in front of these patients and they're able to communicate with these patients, and they're hearing this. This information. And if they don't feel they have a space to provide that, then it just dies inside of that, that room or inside that clinic or wherever they're visiting with that patient. And I think that it's important that we create, as an industry, we challenge each of these entities to, to create those feedback loops. So I guess based on those findings, what can sponsors do differently in that space and how can they create those feedback loops?

Stacey Davidson: 12:08

I think, you know, tightening those feedback loops Absolutely. So that the insights from coordinators are really captured consistently rather than on an ad hoc basis. I think the opportunity really stems from a kind of earlier involvement in GL alignment. So involving site teams earlier, either, you know, in protocol development ideally can really surface practical questions before they become, operational issues or challenges. And also kind of harmonizing those expectations where possible across studies so it's not necessarily about doing more, but as the, you know, as you pose the question, it's about what can we do differently? And it's really about, I think reducing that kind of unnecessary variability, like it can potentially be a little bit more structured is what we were kind of hearing.

Lauren Stockwell: 13:01

A hundred percent. And I really appreciate that challenge to those sponsors and to really help us make sure that we're, we're streamlining that communication. And I think that that's a huge thing. and involving the site as early as often, that is something that SCRS absolutely advocates for on a constant basis if we're not involving the folks who are operationalizing these protocols. In the protocol development, how can we possibly build protocols that are going to work functionally on a site level? So that's a huge, huge mm-hmm. Takeaway for anybody listening. Speaking to that, what, what's like a few key takeaways or different points that Cutsie and Cutsie and yourself and everybody who worked on the site factor would like listeners to really remember?

Stacey Davidson: 13:44

So the biggest takeaway for me, and it's a really interesting one because it was a theme that also emerged from the participation equation research as well, is that. Even though it would make our lives a whole lot easier all round, there is just no one size fits all solution. And we saw this with the participant experience as well. But sites are diverse. The way in which they're set up size locations, there's a number of different elements that make a play here. So they are really diverse ecosystems that have their own requirements as well. I guess the other thing that we want to take away is that Our shared goal collectively, I imagine is really about better trials, better outcomes for patient. So our starting point start to become a little clearer. we really need to support the people who make the research happen every day, who really translate that protocol into practice. And what we've tried to do with this research. It's not about highlighting what's broken at all because so much works really well. It's just thinking about where we can make those small changes to actually start looking forward focused. So recognizing that when that pressure builds quietly, that participant experience starts to shift quietly too. But if we really. Protect the site experience. We're gonna protect the participant experience at the same time. So we value, we invest in site teams and naturally we just create conditions so the better for those participant experiences as well.

Lauren Stockwell: 15:31

Yes, absolutely. And Stacey, I appreciate that sentiment so very much. At SCRS, we specifically say site success impacts everyone in research and mm-hmm. That's everybody from the spectrum of patients all the way through sponsors and, and everyone in between. And so the fact that your team and Cuttsy and Cuttsy has placed so much energy, effort, and resources into building out the site factor and building out this data and collecting this information to really help. Push that narrative forward and really set sites up for success is so incredibly appreciated. So thank you so very much again for joining us, Stacey. We really, truly appreciate your perspectives as well as this Cuttsy and Cuttsy site factor too, for everyone listening up. Please visit site solutions summit.com to save your seat at an upcoming summit. make sure to download the site factor report so that way you yourself can evaluate where you stand in accordance with each of these sites and all of the data collected across the board. Once again, I would like to thank Stacey for joining us here today, the head of Content and Strategy with Cuttsy and Cuttsy, and thank you very much.

Stacey Davidson: 16:35

Thanks, Lauren.