Building Trust and Transparency in Clinical Trials

Mike Stratton, President of CSSi, an Elixia company, discusses best practices for building trust and transparency with clinical trial participants. Mike shares the impact of trust-building initiatives and patient-centric communication on retention, medication adherence, and overall trial success. Tune in to hear how CSSi is reshaping patient engagement—ensuring participants feel valued, informed, and supported every step of the way.

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 Vice President of Site Engagement with the Society, and today I'm joined by Mike Stratton, the President of CSSI, which is an Elixia company, here to share some of the work that they're doing and their perspectives on building trust and transparency with the clinical trial participant community. Mike, it's great to have you really excited to hear CSSI's perspective and some of the work you're doing on this topic. But before we jump in to that, I'd love to learn a little bit more about you and of course CSSI.

Mike Stratton 0:43

Thanks, Jimmy. It's a pleasure to be here. Mike Stratton, president here at CSSI. A little bit of background about myself. I've been in the patient recruitment space for about 15 years now. And that experience spans from startup patient recruitment companies back in 2011, 2012. Through some public acquisitions and bolt ons at one of the major CROs, transitioned into an IRO, an integrated research organization in the decentralized space spent some time over access product in, in the patient engagement CRM world, which is really relevant to what we're talking about today, and ultimately led me here to the leadership position at CSSI. A little bit about CSSI. We are a full service patient recruitment solution or partner. We focus on full funnel responsibility and engagement from a patient perspective and really help orchestrate that patient journey from start to finish. Some of the differentiators that CSSI specializes in, in the last 20 years is really optimizing and, and engaging with patients through that middle part of the funnel process. You know, most patient recruitment providers direct to patient acquisition at the top of the funnel and hand those patients off and burden the sites where we really come in and harmonize the processes. Our team of local enrollment specialists that really build a relationship and nurture that relationship with patients in the middle of the funnel while providing some site augmentation support and alleviating that burden on sites to ensure that patients aren't falling through the cracks and their experience is a positive one. And then lastly, we can get involved through retention and take that patient the last mile. That seems to be, you know, a major milestone and hurdle for us to jump over as an industry as well.

Jimmy Bechtel 2:24

That's excellent. Mike, excited to talk about this. I know you all are uniquely positioned to share to use the word again, a unique perspective on trial participant transparency and building trust. And that's really what we're here to talk about today. So I'd like to start us off with hearing from you. Maybe some of the best practices for ensuring clear and effective communication with participants throughout the trial. We know how important this is, we talk about it a lot. And not everyone does this really well. So I'd love to hear about some of the work again that CSSI is doing in this space.

Mike Stratton 2:54

I think it starts with empathy and accessibility, right? You know, the importance of building a nurturing relationship with your patient community or participant community with patient centric language. That resonates with them and avoid super technical medical jargon. I think it's important to use multiple communication channels in that process. Email, phone, text, in person and really meet the participants where they are. And then, making sure that we're effectively communicating where they're taking the trial. How do we provide them regular updates of, how the trial's progressing and what major milestones are we meeting, and sharing with them in newsletters or frequent communications or even, blasts or alerts that they're a part of something that's going to impact the world from a positive perspective with bringing life changing therapies to market. And even if there's not any information to share, right? We have to share that there's no information or there's no progress and make sure that that relationship stays positively engaged so that we keep them on track, up to date, and involved from a mental state of what they're taking part in to make sure that we continue to solve those gaps that we see continue to burden our industry from patient dropout and things like that.

Jimmy Bechtel 4:10

Yeah, I couldn't agree more, Mike. It's putting yourselves in the position of the patient, honing in on empathy, I think is really, really important and making sure that we come at this from their perspective, understanding that their In a vulnerable position and we're asking them to do something that might be scary to them with a clinical trial participation, given all the stigma and inaccurate information that exists out there. So I think that's a really important place to start as an industry.

Mike Stratton 4:35

It can. You're right. It can be scary, right? And I think to touch on that. How do we provide clear expectations of what the trial process looks like? So, even though we're communicating in patient centric language and we're meeting them where they were from a communication perspective, are we being clear about what the process looks like? What the expectations are of them? What are the potential risks and benefits from the beginning of our relationship with them? And in order to do that. The space is leveraging all the amazing technology at our fingertips, right? There's mobile applications, there's patient portals and it's getting easier for us to leverage that technology to do these things. It's just, it seems to be less and less of something that we pay attention to as an industry. And something that we really double down and focus to, like, how do we train ourselves to be active listeners to the participants and make sure that we're ensuring that they feel valued. It's the scariness right is removed from participating. And providing feedback mechanisms at the end of it. So how do we ensure that we are not only hearing them along the way, but hearing them after it so we can continuously improve what our best practices are on a go forward strategy to.

Jimmy Bechtel 5:43

It's a great point, Mike. And it leads me to my next question because we know that inclusion exclusion criteria becomes very scientific. It becomes very methodical. Sometimes, I would even venture to say most of the time, doesn't really factor into the reality of the patients that are facing these conditions, right? From a scientific standpoint, of course it does. But when we look at whether or not that's going to work for that patient and how it's going to preclude them from that clinical trial, we run into a lot of barriers in this. So, can you talk a little bit about how we as an industry and maybe CSSI's role in this optimize that inclusion exclusion criteria while still ensuring that transparency with the trial participant?

Mike Stratton 6:29

It's a great question. I think it comes down to like three major things. You know, balancing precision and fairness, transparency and building that trust that we talked about initially. When we balance precision and fairness, like we have to fairly define the inclusion exclusion criteria and make sure that we're ensuring the scientific validity but also avoid the unnecessary restrictions that you just talked about. I think using real world data, tapping into the predictive analytics tools that we have to refine the criteria will help make those trials more inclusive without compromising the safety of them.From a transparency perspective, right? Like, explain why the certain criteria is necessary and do it in terms as we talked about originally, in manner that they can understand that we're talking in the context of participant safety and we're keeping research goals in mind as we share this information. And then in our pre screening tools, where we guide the participants on eligibility make sure we make that the most streamlined and efficient process as we can to avoid any delays or disconnections that we leave things open for interpretation to them, right? So the more clear we are and streamlined we are in that process can help. And then from a trust factor we just have to be up front about the challenges of meeting the criteria. You know, not everybody's going to qualify and provide resources for those who aren't eligible to help really explain and drill down into A, why and B, take the opportunity to potentially provide information about other trials or support groups where they might find help that are outside of the particular engagement that we brought them in for in the first place.

Jimmy Bechtel 8:01

That's great, Mike, I I couldn't agree more. It's, again, circling back to that same thing there, it's being attuned to the needs of the patients and listening to them and stop doing this work in a silo and pretending that we're not, maybe I shouldn't go as far as say this, but it seems that it comes across this way. It's like pretending that we're not dealing with actual patients here, actual human beings that we're trying to meld the science and the needs of that clinical trial with the needs and what's realistic for those patients is exactly how we get things forward. And when we separate those things too much, which we tend to do as an industry, we run into problems like mismatched inclusion criteria and trials that patients can't get into.

Mike Stratton 8:40

Yeah. I mean we have to ensure that we take the transactionality out of it. I as an industry, we're looking at units in an agreement or in a requirement of how many people we need to enroll and obviously there's metrics that reverse engineer back up to the start and with a pool of participants that we're trying to search for, but if we nurture them and treat them like patients or participants and not transactional metrics that we need to meet a common goal, right? I think we as an industry should see a better throughput and ultimately better outcomes in our trials because we're treating them like human beings versus mechanisms to meet units in a contract, right?

Jimmy Bechtel 9:17

Exactly, Mike. I couldn't agree more. That's the point that we're trying to make here, which is an excellent one and really important to the future of our clinical trials. So, speaking to recruitment channels that would have had as in your vision or what you've seen. Have had the most impact on including a minority or diverse patient populations in trials. And how have those different channels gone to accomplish building trust amongst those current and potential participants?

Mike Stratton 9:46

I think community organizations, healthcare providers that are connected to the underrepresented populations that we're trying to target. We can get hyper focused on digital advertising. With the social media search engines, targeted campaigns that are aimed at those diverse demographics, informational sessions in the communities, churches, local clinics, awareness events that help build trust inside that community. And with those effective channels, we have to take into account a number of things that we take for granted as society these days. Not every underserved population has internet access to have digital advertising reach them. So meeting the patients where they are is critical to the success of whatever channel that you pick. I think strategies on building trust in those channels like testimonials of people that they trust and know. Understanding the multi language or bilingual needs in those communities from materials, to call center agents, to site staff. You know, whatever it may be, make sure that we make them feel as close to their native environment as we possibly can. Make sure that the materials reflect images and likeness and languages that represent them. So that it's not like this formally hard coded translated thing that may speak in an official language, but not the local language. Right? And then measure the impact that those things are having to make sure that we're not going down a rabbit hole of a recruitment strategy that's going to, A, misrepresent them, B, put us behind from a recruitment perspective and a timeline perspective and not really give them access to the success in a diversified trial.

Jimmy Bechtel (2) 11:21

Great points, Mike. Several really, really great points there. And it's that representation that we know is so important in the clinical trial, speaking their language, helping them feel comfortable and not that they're another number in the cog. And then just kind of we're turning them through what we're trying to do there. And you make a great point. It's hard for us to recognize in this remote world that we work in in clinical trials that Internet is a challenge. But like you said, for a lot of underserved populations and a lot of parts of the world the Internet is not a thing. And it really isn't something that they have access to readily, especially not readily enough to conduct even something as bandwidth intensive as a virtual visit. Maybe you having in home care is not the most viable option for them so we need to bring them somewhere else. But they then in turn, they can't afford to take time off work or get away, right? There's 1000 different things. And you mentioned some great examples, but it's meeting the patient where they are and trying to bring them that clinical trial is to your point where we see a lot of hopefully success going forward. So, Mike, I want to begin to wrap us up here a little bit, but can you tell us how you and your colleagues utilize partnerships within patient advocacy groups, which we know are a strong avenue of community engagement to build upon and bridge the gap between clinical research community and patient populations. And with that, how can that collaboration with those groups enhance that trust and transparency that we started our conversation with today?

Mike Stratton 12:47

Yeah, they're so important. In most things that we do, right? You know, we look at advocacy groups as a bridge builder. How do we build a bridge between us and the community that we're trying to reach? In building those bridges, we help communicate to the patients, how partnerships with advocacy groups really help us identify barriers to participation. And when we are understanding those barriers, it's such a granular level of a community like that we get to create more custom tailored enrollment solutions. That really helps solve the challenges that we probably will not know from an arm's length transaction. Enhancing trust is the 2nd part. So they are trusted intermediaries. They are viewed as a safe haven place for people to get vetted information from people that have either been through the situation that these potential participants are going through. But it really vouches and brings that integrity on benefits of clinical research and trials into the population that we're looking for. They can talk and collaborate with other people that, they can ask and be open with questions that, are they're going to get firsthand experience advice and information back. You know, Co creation of those strategies with them, right? How do we partner with them and not just listen to them and learn in that bridging scenario I gave, but also co create a strategy with them to make sure that we're both involved. They have a great audience. They are. For lack of a better term, the SME when it comes to specific things that we need to know. So, you know, why wouldn't we make sure it's a joint effort to increase that transparency to build that trust? And, and really, work through those group patient led sometimes advisory boards to really come out with that most custom tailored approach for, for a trial. And, I think from a best practices perspective, when we think about advocacy groups, right. It's engaged them early in the design. Sometimes maybe when we get involved, it's, it's, later in the game because we're bringing being brought on in a rescue scenario or,, we're a line item in a budget. But, when our sponsors or CRS are designing the trials, get their feedback earlier on to help them help design right? What that trial looks like with their input. And, I think it just brings a level of mutual respect between recruitment solution partners like us and, and, and those groups to really change the game and the dynamics of how we think about the patient engagement.

Jimmy Bechtel 15:08

Thanks, Mike. It really good points. And, you know, it's, it's a perspective that we don't take as an industry. All the time, at least I don't, and I would venture to guess based on conversations I've had that many of our colleagues don't is, you know, we look at patient advocacy groups and we talk about patient advocacy groups as a way to connect to those patients. But there's also another benefit that you called out that I want to highlight as well. And that is. Talking just to the patient advocacy group themselves. How can we better design our clinical trials and how can we more effectively reach those patients, patients, right? Using them as a partner in this relationship, as opposed to a means to an end is what I'm trying to say and, and what we're trying to do here. So I think that's a really, really important perspective is that they can serve and help. Their constituency group in ways in multiple ways, not only bringing clinical trials to them, but also helping us understand how we again can design clinical trials to meet those needs of those patient populations a little bit better. I think that's a really great place. I think that's a really great place for us to end our conversation on.

Mike Stratton 16:08

Well, it's been a pleasure. Thank you so much for giving me this opportunity. I really enjoyed the conversation.

Jimmy Bechtel 16:14

Yeah, I as well, Mike. Thank you so much. And thank you for your perspectives and the work that CSSI is doing in this space. It's all great, great stuff. And I hope that some of our listeners can come away with some new learnings and some new perspectives on what we're trying to do here to advance the work that needs to be done for current and potential clinical trial participants. I'd also like to add that for everyone listening to make sure that they don't forget to explore other site focused resources made available to the entire community on our website, myscrs. org. This includes our other publications and our summits made available throughout the year. Thanks again for listening and tuning in and until next time.