SCRS Talks
SCRS Talks, hosted by the Society for Clinical Research Sites (SCRS), is a platform for clinical research industry professionals to hear about valuable information shaping the research industry today. These short interviews will provide new perspectives and insights on pressing topics, current events, and the research community.
SCRS Talks
Improving Patient Adherence in Clinical Trials
Megan Gross, Associate Director of Clinical Site Services at AiCure, shares how innovative strategies and AI-driven solutions are shaping the future of patient-centric clinical research. We explore common barriers to medication compliance, the role of trust and engagement, and how AI-powered technology can enhance adherence. Hear practical interventions that sites can implement to support participant adherence, engagement and retention.
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 Megan Gross, the Associate Director of Clinical Site Services with AiCure, and Megan's here to talk a little bit more with us about patient adherence, patient centricity and patient trust in clinical trials. A very important and timely topic and one that we constantly circle back on. So Megan, before we jump into our discussion, I'd love to learn a little bit more about you and your background as well as what AiCure does.
Megan Gross:Yeah. Hi, thank you so much for having me. I'm really excited to be here. So as you mentioned, I'm the associate director of clinical site services at AiCure. And to understand what that entails I'll tell you first a little bit about AiCure. So it's a clinical trial technology company that uses artificial intelligence and computer vision for medication adherence and digital biomarkers. The technology is deployed on a participant's smartphone and supports a decentralized environment. And for medication adherence, what that looks like is the participant takes a video selfie of themselves dosing with the study medication, then that video is reviewed by our proprietary AI for confirmation of ingestion and adherence captured in this way with AiCure is unique in that it's predictive and early adherence captured with AiCure is predictive of both overall study adherence and early withdrawal. So it can be really powerful data And so what I do is I developed and now lead our central monitoring function called Clinical Site Services, where we monitor study data that's collected through the platform against key performance metrics and drive improved outcomes in adherence, behavior, compliance, and engagement and retention. And in return, you get more in your study and can even reduce cost through retention or decentralization efforts and I additionally support our scientific research endeavors. Prior to AiCure I've spent over 10 years in both the academic and industry sides of clinical research and worked on studies funded by the NIH, pharmaceutical sponsors, several reputable foundations, and institutions and I have two graduate degrees in clinical research both my master's and a postgraduate certificate in clinical research as well.
Jimmy Bechtel:Great. Thanks Megan. And really excited to talk about this subject with you because I know obviously AiCure sits in this space and we know how important it is for the perpetuity of and the good science of the clinical trials that we're doing. And we're here really to talk about the interventions for improving patient medication adherence. So let's start off with learning from you about what are some of the common reasons that we see participants struggle with medication adherence in their clinical trials and maybe include, you know, some of the factors we know affect this things like financial compensation or concepts like provider bias that influence patient behavior and how that kind of goes to affect again their adherence.
Megan Gross:Yeah, so non adherence in a clinical trial can be intentional or non intentional. So, non intentional medication adherence, meaning the participant is forgetting every once in a while to take their medication or struggling with making daily dosing with the new medication habit in their daily lives. Whereas intentional non adherence, meaning the participant knows that they're supposed to take their medication, yet they actively choose not to and there's factors contributing to both of these things, and it kind of comes in a range. So some basic factors could be just that they need support in simply building that daily dosing habit and working that into their daily routine. Of course, like you mentioned, financial compensation can be a motivator for, you know, focus on this in their routine. But especially, we found that rapid reward compensation in which the participant immediately sees the benefit is much more powerful and impactful than a lump sum kind of at the end of the study. So we've built in micro reimbursements, usually of like a dollar after every dose that accumulates over the study. Yet, Sometimes these things are not enough, and there are other influences, like you mentioned, such as provider bias in and wanting to not admit to the provider that a participant themselves was not 100 percent adherence and we can see this intentional non adherence as evidenced by our video capture method where a participant actually reported to the site that they took the pill. And the pill count shows that they took their pill. But the video actually demonstrates that they didn't take it and they didn't actually ingest the medication. And motivations behind this type of non adherence are really complex. It could be bias, they could be experiencing a side effect or an adverse event that they feel embarrassed about or don't want to admit, or it could even be social or personal. So it's really a range of you know reasons why participants struggle and it can be very simple up to a really complex case.
Jimmy Bechtel:Yeah. It's interesting, Megan, because we know like you said, it is complex. It doesn't ever seem to just be one reason or even for the same patient. One reason could arise, we alleviate or resolve that reason and then something else happens, right? With those patients. They're people too. And then we add the complexity of clinical trial medication adherence, right? It's oftentimes not just simply taking a pill in the morning, right? With breakfast, it becomes very complicated and very confusing. And sometimes we overcomplicate things and it just ends up being confusing for the patients. And I know we're going to talk a little bit about how we can work to improve that, but I appreciate the reasons. And I do like that idea, you know, one of the examples you gave where that lump sum isn't helpful, right? It's not all the time. Some patients, need that reimbursement in a more immediate fashion to be able to cover their expenses that they incur as a result of participating in the clinical trial. We talk about transportation and we don't need to get down that road today, but it is a really interesting concept as we approach, you know, what types of compensation models again, a conversation for a different time help perpetuate and enforce adherence without being coercive or biased. Right. I think that's a really important point that you made. So based on recent research, Megan, what are some of the key factors that are then essential for establishing really effective interventions to improve that inherent, you know, we talk about things like trust and engagement and rewards. Some of those things that you had mentioned and in the environment itself as being some of those examples. But maybe you can dive into some of those and share what you guys have seen.
Megan Gross:Yeah, yeah, absolutely. So good news is that clinical site driven intervention or follow up with non adherent participants to remind them to take their study medication can be an effective way to alter a participant's behavior and even restore adherence. And what we know is that intervention is a spectrum. A simple routine, schedule, or an alarm might be enough for some people to maintain that good adherence throughout the period of time of the clinical trial. However, some people may need some additional support, and that could be like a text message, a phone call, an in person discussion from their site to stay adherent. And research has shown that participants need established trust, continuous engagement, and have fast reward and and be in a non accusatory environment in order to even be open to modifying their behavior to restore adherence. And similarly, the research has shown that these needs also support reduced early discontinuation rates or early termination rates in clinical trials. And most importantly, one of the key drivers for maintaining adherence or restoring non adherence is response time from the site. So in order to have effective interventions for adherence restoration, it's critical that the sites are able to even see when non adherence occurs and be able to intervene in a timely manner. And you know, all those other things that we just mentioned, having that trusting open environment as well.
Jimmy Bechtel:Thanks, Megan. Yeah it's really interesting. The concept of this constant touch point and it's something that we have to build in and you have to, you kind of have to put work into and reinforce, we know that to your point, because when patients don't feel appreciated or rewarded or however you want to, however you want to frame it for this participation on an ongoing and regular basis, I can imagine that the rest of it is really hard to establish and perpetuate, right? That trust is challenging. The comfortability of the environment can become challenging. So even if it's not necessarily a reward that's tied to that, but just the appreciation and that check in and that I guess it really is that keyword that you mentioned, right? Engagement on a continuous basis can really set us up for success with the rest of the things that we can do to improve medication adherence.
Megan Gross:Yep. Absolutely.
Jimmy Bechtel:Can you also then kind of continuing this thread, share some examples of successful interventions, it's simple things, right? Like reminders to even up to complex things that we've seen or you've seen that can improve medication adherence.
Megan Gross:Yeah, definitely. So what we're alluding to is that a successful intervention can look different for two participants in the same trial, and even two participants in the same trial at the same site. And when we're thinking about what a successful intervention looks like, it's helpful to think about the different patient profiles based off of adherence patterns to really hone in on what you need to do as a site. So I'll give three examples. For some participants, just having simple reminders in the app or the actual act of taking a video selfie every day and like that visual action is enough for them to build and maintain that habit. And our research shows that it takes about 14 days to create this new habit. So if you do it well in the first 14 days, likely the participant is going to continue for the rest of the trial. And this participant's medication adherence rate will often be really high. It's like 90%, even 100%. And as you just mentioned, the site should really focus on positive reinforcement. So when you have those visits or phone calls, even about other things, just say, Hey, way to go, good job on your compliance or good job on your medication adherence. And just acknowledging that it's really important. It's really impactful. So for another example, there are patients who need a little bit of more engagement from the site. So like a check in every once in a while or a quick follow up for that occasional missed dose, always the site should be providing encouragement, acknowledgement, praise you know, just like you mentioned, it can be really challenging to be in a clinical trial and participants want their efforts recognized and they don't just want attention when they miss that one dose and that can feel really, really, really isolating almost so this type of participants adherence rate might be 70 percent or 80 percent with occasional missed doses. They're not often missing consecutive doses back to back, and they need that little push, but they're generally meeting the requirements of the protocol. And then finally, of course, we'll always have those participants who need that extra high touch support, so that could be multiple phone calls from the site to the participant, sometimes in person discussions or multiple in person discussions to really understand what is impeding adherence and really having the site work with the patient as their partner to guide them to an adherent dosing schedule and meet them where they are. This participant's adherence rate will be low. So I've seen zero to 60 percent and wide range and there's different patterns in there but you'll see things such as consecutive missed doses, inconsistent dosing times, disqualified or the AI flagged doses for non adherence even pending data with with our app, with AI Care, that means that the participant hasn't connected their device to the internet or even turned on their phone in the while, in a while which means they're just disengaged and not reporting their data. So thinking about a successful intervention as a whole, it's kind of overwhelming sometimes, but if you break it down to what is this participant doing and what does their adherence trends look like, then it makes it really simple to understand, like, okay, this could be a good next step for this participant based off of their data.
Jimmy Bechtel:Thanks, Megan. Really cool examples. And I think really important lessons from each one of those. And one of the things that I took away was, we've kind of said previously, and one of the things I'm taking away from this conversation overall is just that appreciation. Just saying thank you or good job or we noticed that you did what you were supposed to do. It's a concept that we can perpetuate into our general lives, but it applies here to like, don't get so caught up in the checking of the boxes and the doing of the thing and the pill counting and this, that, and the other that you forget that there's a human on the other end of that, who is potentially scared, potentially nervous, not sure if what they're doing is correct. They're in a new environment. They might have a new condition, a new disease that they're fighting that can be extremely terrifying. So these little acts of appreciation and humanizing that process, I think it sounds like you've seen evidence that those things go a long way.
Megan Gross:Yeah, for sure. And that's that maintaining that adherence and maintaining that compliance. That's, you know, really, really impactful.
Jimmy Bechtel:Yeah, exactly, Megan. And so let's talk about that, right? How does then, how have you seen that continuous engagement, that concept of continuous engagement contribute to improve retention? And how can we really, as we wrap up our conversation, how can we ensure that follow ups are again supportive rather than overwhelming.
Megan Gross:Yeah, yeah, so just along the lines of what we've been saying and interesting what we've seen in our research as well as in the literature is that site behavior and site compliance also contributes to participant non adherence. So tools such as AiCure for capturing adherence render it feasible to see non adherence. But the site staff must still use the tool and engage with participants in a timely manner for it to be effective in achieving and maintaining the adherence in the trial overall. And questions from the site like, Are you taking your medication is not enough patients need open support, a trusted environment, and targeted open ended questions about specific days medication was missed and that quick follow up is needed. So in terms of continuous engagement, it's so important building that trust with the patient before non adherence occurs. And when that adherence needs to be restored, a patient is much more likely to respond to someone they know than, you know, a random notification in the app or random text message. And this is especially important in intentional non adherence. So the site can go to the patient and help them get on track in a friendly, open, and supportive manner. So I think establishing a mechanism for that continuous engagement throughout the trial is really key so that when things do become non adherent or non compliant you're more effective in in your intervention.
Jimmy Bechtel:Exactly. And you're more likely to get back on track with things, right? Having established a process along the way and being proactive and not being reactive, another classic, a cliche that we can implement to our discussion here. That is really, really important and really, really applicable is building these systems in and it's great to know that that's such a focus for AiCure, building these systems in at the start at the beginning of the trial and perpetuating them through it sounds like a way that we can ensure that continuous and ongoing follow up, which is awesome. So another, another great lesson and a little tidbit for our listeners to take away from today.
Megan Gross:Yes, absolutely.
Jimmy Bechtel:Well, Megan, it's been great. It's really been an interesting conversation. This is a topic that I'm sure there are countless conversations about and the summit topics and conference discussions. We could spend hours talking about this, but there's been a lot to absorb in this 15 minutes that we've been together. So thank you for your time. Thank you to AiCure for the work that I know you're doing in this space to use technology to enhance our ability to do this. And thank you of course, for the conversation today.
Megan Gross:Thank you so much. It was great to be here. I'm really excited to continue this work and continuing to work with SCRS.
Jimmy Bechtel:Absolutely us as well. And I hope that our listeners come away with some new learnings and perspectives to advance their work. 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 site community on our website, myscrs. org. This would also include opportunities like our site solutions summits, and other podcasts and publications made available throughout the year. Thanks again for listening and tuning in and until next time.
