Cultural Understanding in Clinical Trial Recruitment

Sit down with Kate Shaw, Founder and CEO of Innovative Trials, to explore how humanized, bespoke approaches are reshaping patient recruitment and retention in clinical research. Kate breaks down the difference between one-to-one, in-country support and automated recruitment systems, showing how local expertise and cultural understanding can dramatically improve trial outcomes. You’ll also hear how the Patient Support Center and dedicated patient navigators guide participants step by step, ensuring they feel informed, respected, and cared for throughout the trial. This episode uncovers how personalized strategies not only boost recruitment success but also lighten the load for sites and create a more meaningful patient experience.

Transcript

Jimmy Bechtel: 0:01

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 Jimmy Bechtel, the Chief Site Success Officer with SCRS, and I'm joined by Kate Shaw, the founder and CEO of Innovative Trials here to talk with us a little bit about recruitment and how some things are really taking shape in the recruitment space, and then some cool things that are being done here. Kate before we jump into that, I'd love for the audience to learn a little bit more about you and Innovative Trials.

Kate Shaw: 0:36

Thanks Jimmy, and thanks for inviting us to SCRS Talks. We are really excited to be here, so thank you. I'm Kate. Myself and my parents set up Innovative Trials now 15 years ago. And really the reason why we do this, we want to make sure that any patient going into a clinical trial is really informed of what will be happening in the trial. My background is pharmaceuticals. I used to manage trials globally for Roche products, the uk division of Roche. And really my whole aim is to ensure that patients are given everything they need to make their informed decision about being in a trial. Education materials, having people to speak to, and understanding kind of what the trial means to them and their family. Like I said, 15 years we've been going and we really focus on humanized patient recruitment. How we can support the patients, how we can support the sites? And how we can make sure that we're recruiting patients who are a hundred percent informed, understand what they're doing, and really committed to be in the trial for the whole duration of the trial.

Jimmy Bechtel: 1:33

Thanks Kate. Really great to hear that there's an organization out there that provides that detailed and really precise recruitment support. We know that's a huge aspect of clinical trials and a big win for the patients. I wanna dive into that a little bit and talk about this concept of one-to-one in country support and what that really looks like in practice and how it differs from some of what we're used to around automated recruitment systems.

Kate Shaw: 2:00

Yeah, thanks Jimmy. The main word actually is bespoke We are doing bespoke patient recruitment and retention support, working with sites globally. We work in over 70 countries. We've been doing this for now, 13, 14 years. Between us all, we've done over 40,000 calls. We're super experienced in this. What we've realized is that every site is different and so it's really important to work with them with what they need for recruitment. They might need net help on communication. They might need help on referral networks or patient groups, or understanding kind of how to recruit patients for this study. The main thing is bespoke and we are there to support the sites. We're there to share ideas and understand exactly how we're going to recruit patients. When we're doing this, we'll help them develop site recruitment plans, maybe look at their patient pathway. Every patient pathway is different for different sites to understand who else could potentially help us recruit patients. Who else sees these patients that also we can tell about the trial. And then actually building relationships. We're there to support the site. They might be really well in recruitment. They might be struggling, but we are gonna be there for the whole duration to help them and share best practice ideas globally. All our team will get together, they'll understand what's happening in Germany, what's happening in the U.S., and help the sites to kind of learn from there with the colleagues. The people doing these calls are called clinical enrollment managers and they're really experienced clinical research professionals. They're based in country and they understand their regulatory requirements. They understand the culture of where they are, and ultimately they're then able to help the sites. They're a great bunch of people. We've worked with them for a long time now, and they're there to kind of build those relationships and bring the human element kind of back into clinical research.

Jimmy Bechtel: 3:47

Thanks, Kate. A huge part of what we hear is complaint point of the sites, that we use these one size fits all recruitment campaigns and we know that they have minimal effectiveness because each geographic area, each site, each patient, each experience is individualized and it is different. It's cool to hear that there are solutions out there that, are bespoke and they are tailored to the individual organization and what their unique needs are. It's not something that we see a lot of in the industry. Really cool to see something that's solving that specific challenge.

Kate Shaw: 4:23

It's super important. Like none of us want to be seen as all the same, do we? We're all different. The way that we are communicated with, the way that we show up, everyone's different. What we do as well within the calls, we ensure the calls take place at a convenient time for the site staff. We're able to do this before the clinic starts, after the clinic starts, on a lunch break. We want to be at the convenience of the site teams rather than the convenience of ourselves. We ensure that the site teams come first. We want to be there to support them and help them. We understand that the patient will always come first. If theres a patient in the clinic, our calls will get postponed and we'll reschedule'em for a time when the site staff do have time to speak. We're really flexible but want to give the site team the support they need and they deserve, helping them to ensure that they're gonna recruit well for the study. Feedback from the sites is they appreciate having that time to just totally focus on this one study. They might have 20 studies that they're looking at. For the next kind of half an hour, we're totally focusing on one study and one study alone. And then at the end of it, there's ideas, actions, thoughts as to how we're going to kind of recruit for that study and then go back to the day job of recruiting for everything else as well. It's a really bespoke, interactive, conversational, and time that the CEM will have with the site team.

Jimmy Bechtel: 5:38

That's excellent, Kate, and really important aspects of what I imagine are the successes of this type of approach to that. I want to talk about the local cultural understanding. Why we talk about this concept of tailored support, individualized, bespoke support. How critical is that understanding in patient recruitment? And can you maybe give an example or two of where this has really made a difference in a recruitment effort?

Kate Shaw: 6:05

Culture is so important, isn't it? It's gonna be so much better for somebody from Germany ringing a German site, rather than me trying to speak my best German. I don't understand the culture half as well as somebody actually living in the country. We ensure that people live in the country, they understand the culture, they understand how to communicate, who's the best people to communicate with sites. Giving an example, we've recently worked on a trial for melanoma. It is a phase two obesity. 118 sites across 25 countries. We were brought in to work with the sites on recruitment and recruitment challenges. Over the 24 months that we were involved, the sites that received our support vastly out outperformed the sites who didn't receive our support. The results being that 72% increase in screening rates for sites we supported and a 45% increase in randomization rates. We see these results in pretty much all of our studies that the sites who we support do much better. It's there because we're there to keep motivating them, keep giving them ideas, topping them up maybe when they're feeling a little bit demotivated. Really working with'em to understand the challenges and then put solutions in place. We're really proud of those results actually, and it showed that the CMs are doing a fantastic job and understanding each site's requirements on their recruitment efforts.

Jimmy Bechtel: 7:23

That's really awesome because that's such a lacking space in the recruitment place. We don't see it all the time. We try and we talk about taking patient cultural differences and we'll use the blanket term of cultural'cause I'm sure this could apply to a lot of other recruitment unique aspects of patients when it pertains to recruitment that aren't just cultural, but it's such an important thing that we seem to gloss over. Taking a specific approach to that and tailoring that, taking those 10 things into consideration just kind of adds to the value of an approach like this. And like you said, enhance the capability of sites.

Kate Shaw: 8:01

Yeah, it really does. It's using the experience of people who really enjoy working with sites. Most of the people actually do this work, are really senior. They've been doing this 15, 17 years plus, and what's kind of brought them back is they like working with sites. They might have held like really senior jobs in other pharmaceutical companies, but the bit that still really motivates'em is working with the sites and supporting the sites. It's kind of the best of both really for everyone. We've got these great experienced people who want to do this job and the sites benefit as well from their experience. Plus they're the close experience as well. In some ways it's a bit of a match made in heaven that. People enjoy what they do and they enjoy the results. We're actually seeing the sites achieve as well. It's a nice job to do. And like I said, we do get some really great feedback from the sites who actually appreciate what the CMs are doing and what they're bringing to the table, rather than sites being kinda left on their own and just hoping that they will recruit. Recruitment's a lot of work and the more support people can get, the better they're gonna be.

Jimmy Bechtel: 8:59

I couldn't agree more, Kate. It's such a critical aspect of what we're trying to do with patient recruitment, but another critical point that we talk about a lot and haven't really cracked the code on. I'm interested to hear your approach to this. Can you talk a little bit about how your patient support center humanizes the trial experience for patients because, for so long, we talk about how this is scary for patients. It's intimidating, it's robotic, it's standardized, the patient doesn't feel important. Can you talk a little bit about how what you're doing in this space.

Kate Shaw: 9:36

We set up a service called patient support. We have patient navigators again who are global. They live in country, they speak local language. They understand clinical research and what they're there for is to support the patients through their journey. Obviously they're getting support from the site, which is great, but having a neutral party who's there? Who understands clinical research. And it's really there for their emotional support. We're not medics or for the standard service we offer, we're not medics, but it's people who understand clinical research. If you put yourself in the patient's shoes, most patients, it's the first time they've ever been on a trial. It's a scary experience. They don't know the language we use. They dunno what's gonna happen. They've got a supportive person who's there who will ring them on a regular basis, or they can ring and they can ask anything they want to ask, if they've got concerns. For example, they might not understand what the word placebo means and they don't want to ask the PI or the study coordinator on the study in case they come across or they feel silly for asking. We've got people there who can answer any question they might have on the trial and also offer them that emotional support as well. We've got a study that's likely to get going for Alzheimer's. And we're looking to bring on the navigators for both early to moderate Alzheimer's and as it starts, but we know it's highly likely, and sadly patients progress. And so we know kind of towards the end of this trial, it's likely to be the caregiver actually needs the emotional support rather than the patient themselves. So the support is there for both the caregivers there for the patients. And so they can really ask what questions they want to, and sometimes if they just need some support or the study's really hard, we don't understand why we have to do this. We can explain why they need to do the procedures, why it's important that they come back for the visits. They're really the neutral capacity to come and support them. The same person will be calling the patient over the period and so they're building up trust. Instead of me having to explain 50 times what I've got and the conditions I have and how I feel, and I don't have to do that because it's gonna be the same person that rings me. We drive engagement and there's driving a relationship with the patient navigator and the patient or the caregiver. The end of the study they've been supported, they've been absolutely treated with respect and shown the superheroes that they are for being in clinical research and volunteering their time and, their trust. The patient support is so important. The sites do a really good job of supporting the patients. We're not taking that away, but we're helping the sites as well, just so that we can give them all the time that the patient needs. We do this for recruitment as well. We had one study for PTSD. The patient had so many questions. They were on the phone for like 45 minutes asking about the trial and what would happen and stuff. That's a huge amount of time for the site to give to one patient. But we're able to do that. We're able to be there for them to make sure that by the time they finish that call, they feel confident to make their decision and their decision. To go in the trial. It is their decision. If they decide not to go in the trial, that's their decision too. We've given them all the information they need to make that informed decision. And that's kind of how we see our job. For recruitment, for retention, it's really the same. It's just to support the patients. We had a early asthma study and we thought we actually wouldn't get many calls because we thought the patients pretty well. It's a decentralized trial. They probably won't need the support. What we found on that one was that the patients actually really needed support on the electronic diaries. They struggled with the diaries. They didn't know what to do, they didn't know how to work them. We went back to sponsor and said, look, if you can train us on the e diary, we can then train the patients and anybody else who happens to ring. We ended up taking up a bit of tech support for the study too, to make sure that the patients understood the e diary.'cause we had so many of the patients actually threatened to withdraw from the study because they were so frustrated with the diary. By giving them the tech support, helping them out, it kind of took away their frustration. And ultimately they stayed on the trial, so which was better for them and obviously better for the trial too. It's quite a varied service again with bespoke we kind of adapt it as to what that patient needs and also what the study needs as well. It's definitely a growing service and it's nice to be able to give kind the patients the support that they deserve

Jimmy Bechtel: 13:49

It's really cool, Kate, because it's so personalized, it's so individualized, and yet it's for the clinical trial. Do you know what I mean? There's this juxtaposition here of how important it is that we provide this care that is appropriate for the needs of the sites and the patients as individuals. Yet you're working across all these different trials and all of these different sites. It's this concierge level service, this bespoke, as you described it, level service that really does put the patient at the center of this effort that I think probably makes a huge difference for what we see with outcomes for these trials.

Kate Shaw: 14:25

Yeah, absolutely. We are there from the beginning to end and ultimately building on friendships that people are kind of appreciating the fact that someone's calling and checking in on them and you've got everything you need and the visits next week, it's three hours long so make sure you take your book and all those kind of very simple things, but very important things that people might forget. But we are there to kind of ensure that the clinical trials experience is as nice as it possibly be. We can't obviously predict whether the trial's actually gonna work or not, but we can really help to make sure the experience is as nice as it possibly can be. And they come away at the end of the study saying, I was treated with respect. I felt appreciated and ultimately, I enjoyed being part of the trial'cause that's what we want, isn't it? We want people to have had a nice experience rather than feeling that they weren't treated with the respect they should be. That's really what we're trying to do in the whole service.

Jimmy Bechtel: 15:16

And it's important too, as an aside, that we treat those patients with respect from the beginning, as you've emphasized through your explanation. Because even if they don't qualify for that trial, they might qualify for one in the future or for another trial. We want to make sure that that experience, from start to finish, they depart that experience, they leave that site with their dignity intact, their respect intact, so that if in the event we or another research site or another institution, another fortunate or unfortunate opportunity presents itself to them for a clinical trial that they don't even hesitate. They say, my experience was so good last time because I had all this support from the site and from Innovative Trials that I am not even gonna bat an eye and I'm absolutely gonna explore participation.

Kate Shaw: 16:03

Absolutely. That's what we want. And we're not taking away what the site's doing. The site's doing an absolutely fantastic job. We're there to kind of top up what they're doing. We a hundred percent appreciate all the effort that sites go to as well, to do this and keep the patients informed. They're just so busy. Right. So it's nice that we're able to offer this as well.

Jimmy Bechtel: 16:22

I wanna ta talk about this as we begin to close our conversation here. The aspect of early human connection. How do early human connections impact that retention throughout the trial? And what types of warning signs do you watch for as you're navigating this journey for and with the patients?

Kate Shaw: 16:41

Yeah, the early connections absolutely is all about generating trust and reducing the barriers and increasing engagement. What we spoke about earlier the more connection we can have, the better. We can understand, what motivates the patient, what they're finding difficult. But warning signs do happen and we do know that patients withdraw from clinical research. And so warning signs that we see is decreased communication. We're noticing the patients kind of aren't maybe as engaged as they were. They're not able to take the call when we ring them. Potentially signs of frustration as well. Like I mentioned in the asthma trial, the patients were frustrated about the e diary but also some patients weren't getting paid and it was a decentralized trial. They expect to receive their reimbursement Things like that can start making a huge difference. The more we can solve those problems. People missing calls, they're showing signs of frustration and maybe getting a few little complaints, or this is too much for me. It starts becoming more obvious, then our job is to understand and to see what else we can do to help them. In the case of the e diary, we were able to sort that issue out in the issue of patients not being paid. Again, we were able to work with the vendor who was providing the payments to actually ensure they got paid, and in some ways, in decreased communication. It's just really talking to the patient. What's happening, why are you feeling like you do? And the more relationship we have, the more likely they're to share with us. It might be absolutely nothing to do with the trial and something else that's going on in their life that's causing challenges. But more that we're there for them, we're more able to understand the challenges they're facing and maybe work then with the site teams if there's anything else that can be done for the patient. It is back to communication, really, trust empathy and being there for the patients.

Jimmy Bechtel: 18:24

Well, Kate, I think that's a really great place for us to conclude our conversation. Leaving it on that note of doing what's best for the patient and really focusing on them building the process, the system and the support that you all provide around what's best for the patient and how you can support the site, right? Like you had mentioned to best, continue that support for the patient as well. Thank you for your time today. Thank you for the conversation and the insights into some really interesting things that are being done in the recruitment space and again. Thank you for being with us.

Kate Shaw: 18:58

Thanks Jimmy. And thank you for what SCRS do. You do some great work, it's great to be involved. Thanks for your time too.

Jimmy Bechtel: 19:04

For those listening, I wanna make sure to bring your attention to other site focused resources made available on our website, my scrs.org. Like other publications, other episodes of SCRS talks, and our Site Solutions Summit, where you'd have opportunities to engage with our partners and others across the industry. For now, thank you for listening, for tuning in, and until next time.