Patient-first Approaches in Clinical Trials with Megan Liles

December 27, 2023 00:43:13
Patient-first Approaches in Clinical Trials with Megan Liles
Power to the Patients
Patient-first Approaches in Clinical Trials with Megan Liles

Dec 27 2023 | 00:43:13

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Show Notes

Explore the world of clinical trials with our guest, Megan Liles. Drawing from her 25+ years of experience, Megan offers a practical perspective on the importance of prioritizing patients in clinical trials. She discusses the role of patient advisory boards, improving access to clinical trials, and understanding the real-life impact on patients. Megan emphasizes the significance of incorporating patient-centric approaches into clinical trial design.

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Megan Liles

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Episode Transcript

[00:00:03] Speaker A: Welcome to power to the Patients, a LinkedIn live and podcast series hosted by Power, where clinical research leaders across sponsors sites, CROs, and patient advocacy groups discuss patient centricity in clinical trials. We explore the bottlenecks in today's system, challenge the status quo, and talk about future opportunities for innovation. Let's dive in. [00:00:31] Speaker B: Well, hey, this is power to the patients. I'm Brandon, your host. We're joined here today by a good friend of ours, Megan Lyles, who's currently the VP of clinical operations over at Prokidney. Megan's been a strong advocate for patient centricity and innovation in the clinical operations space, and we thought, well, what better guest for us to have on board here and have a conversation about the kinds of innovations that's happening on the front lines? So, Megan, welcome to the show, and maybe I'll just give you an opportunity to kind of take us through your journey for how you got here and how this became a core part of what you do. [00:01:05] Speaker C: Yeah, sure. Love to. And thanks, Brandon, again, for inviting me to talk with you today, because I do, as you mentioned, always love going down the rabbit holes that we tend to find ourselves in. So I've been in the industry for a long time. I've been doing this for over 26 years now. Started off as a research coordinator in downtown Detroit, working with patients living with HIV and AIDS and enrolling them into NIH and sponsored trials. And so that kind of kicked off my clinical research journey and got a little too tired of the cold up in Detroit, so moved down to North Carolina because that's where I knew the CROs were and became a manager, and then have worked my way through being both on CRO and pharma side, really working through the CRA project management path, project director, oversight director, operational strategy, and then to where my current position is here at Prokidney as vice president of clinical operations. Really with that. It was, interestingly enough, during the early months of 2020 and the pandemic, when I was doing a presentation about making patient stakeholders, and it really resulted in preparing for that, resulted in me and reflecting just kind of the background that I've had and just some of the things that we did with our patient population in Detroit in the late 90s that we really lost touch with. And that was using having patient advisory boards, which is a huge buz thing now is everyone, we need to talk to the patients. And that's what we did. We did that back in Detroit. We had regular meetings with a group of patients, and they would tell us about the protocols, what's working well, what's not working well. And we were able to use that feedback and help drive protocol design for subsequent studies. So there's a lot of those nuances that we did early that we really have lost focus in being able to help the patients find clinical trials so that they can participate in them, because I saw firsthand how participating in a clinical trial really positively impacted these patients who back in the late 90s, when you got a diagnosis of being hiv positive, that was almost nearly a death sentence for that individual. So that's where I started turning more into what we can do to improve things for patients and making clinical trials more of a care option for. And because that's, again, what we were doing back in Detroit, is making sure that they had these options available to them. So that has been really what I've been focused on the past several years. And then here, interestingly enough, I had been focused in oncology for quite a number of years, and then coming into where I am now working with chronic kidney disease. It's an interesting population because there is a high prevalence of chronic kidney disease, but again, there's not a large amount of clinical trials going on with this patient population, so they don't have the awareness of clinical trials that are available to them. And so it's how do we do this and how do we make patient stakeholders in clinical trials? So that's kind of in a long way how we kind of arrived to where I am today, and really why I'm kind of looking back to my earlier experience to be able to help inform what we're doing today and how we can truly make patient stakeholders in our clinical trials. [00:04:53] Speaker B: Yeah, absolutely. So I want to learn more about that. Actually. When you say make patient stakeholders, what are all the things that go into that? [00:05:00] Speaker C: Well, making them a part of the process and making sure that the protocol that the studies are designed. Keeping in mind, is this going to work for this particular patient population? Does it align with the visits that they're already having for whatever therapeutic area that this is in? And what do we need to do? What accommodations do we need to make in order to allow patients to participate? The clinical trials are taking us a significant amount of time even to go to the doctor's office these days. It's a couple of hours just to sit in the waiting room and then wait to be seen and then anything else that needs to be done subsequent to that. Clinical trials are requiring a lot more procedures in terms of imaging that all need to be done at separate facilities. And trying to figure out the logistics of scheduling that with the patient schedule. Because the thing that's interesting to me is that we somehow forget that the patients work, that they have jobs and that they're having to take time off from jobs in order to participate. And there's almost this, like they're just sitting there ready for us to waiting for this to happen, but we're not taking into consideration their lives. And that really resonated with me when I was working on a study a few years back in an indication that was predominantly in females and they were already stable on their medication and then asking them to take an investigational product. And so I just thought about myself and I was like, well, if I were that person, I would say, well, I don't have time to do this, I'm busy, I feel fine. Why would I want to take something else that might impact what is already, if I'm already stable and I don't have time to go to doctors visits, I'm busy, I have to work, I have to go to take the kids here, there, everywhere. And so it's trying to take that consideration into mind of being considerate of the patient and what they have available. But then also the one area that I feel like we really do a disservice is that as an industry, and the most fascinating thing to me is that we talk about patient centricity, we talk about making patient stakeholders, but we make clinical trials next to impossible for them to find. I did see recently that clinicaltrials gov that they've reorganized and they've tried to put maps and give more information and make it a little bit easier. But at the same time, it's still a very confusing platform to navigate through, especially if you're, and it's not something that the normal person is just going to pop onto clinicaltrials gov and try to find a clinical trial unless they're particularly motivated. So it's almost like we don't want them to participate because we're putting all of these barriers in place to prevent people from participating in clinical trials. [00:07:56] Speaker B: We're going to quote that one. [00:07:59] Speaker C: That's great. [00:08:00] Speaker B: That's going in the marketing for sure. [00:08:03] Speaker C: Well, it is that we make informed consents too complicated. You need almost an advanced degree or medical degree sometimes to decipher even what is going on. Therapies have become increasingly complex in terms of how they work or what their requirements are. With our company, we're a cell therapy developer and there's other cell therapy developers. There's a lot more gene therapies. And all of these have very nuanced requirements that are not going to be familiar to the general population. So it's an interesting thing to be in that we make it difficult for patients to participate in clinical trials. [00:08:47] Speaker B: A lot of what you just said makes sense. I don't think that anybody who's listening is thinking, oh, Megan is totally going off in the wrong direction here. Why hasn't it happened? It feels like everybody is aligned to this vision, at least most people that I speak with. So why do you think it hasn't happened? [00:09:03] Speaker C: I don't know why it hasn't happened. We've been talking about it. Econsent became available. I mean, gosh, I was talking about econsent back, gosh, probably 1012 years ago when we started talking about econsent, and it's still not adopted, and we still don't do that. And we still give patients a 25 page document and say, here, read this, and then let us know if you want to sign up. And a lot of the sites, the investigative sites, have processes around the informed consent process. At the end of the day, we're still giving a very technical document to a patient, and it's not broken down in a manner that they can understand. And I don't know if it's because of cost. I don't know if it's because of logistics of econsent. And that's just one of the examples. And we're increasingly hearing, too, that scheduling has become problematic for our studies. We require imaging. So does every other oncology trials and so many others. And so there's a limitation on the number of facilities available to be able to do those types of procedures. So the complexity of the trials and the requirements of what we need in order to make sure that the product is safe and effective, that it doesn't align with just the normal. We're going to imaging centers that are also seeing patients that need to have scans for other reasons, not just clinical trials. So I don't have a good reason why. Other than that we laugh that the pandemic has forced us to embrace decentralized trials. And there was a lot of talk about as soon as it happened, can we maintain this momentum where we're doing things more virtually, that are more patient friendly, relying more on mobile health, cutting down the number of visits, cutting down the number of procedures. And I think there was optimism for about a year or so, and then we've really started to see it swing back the other way, where the protocols are, again, very stuffed with procedures and labs and everything in between. And then also, I've heard there's more of a movement away from moving to doing mobile health visits and meeting the patients where it might be convenient for them. So it almost seems like we swung one direction and thought we could maintain the momentum, but now we're kind of coming back to the way we are. The only thing I can tell you is that for all of the innovation that's going on in every other field, for whatever reason, clinical research is one of those industries that has been very slow to really embrace innovation. I mean, you can even say that about electronic data capture, which that's been around for 20 years, I think, at this point in time. And I think I did a paper trial, definitely within the last five years, we had to do a paper CRF trial. [00:12:06] Speaker B: Sure. [00:12:07] Speaker C: Yeah. And it was still an option, too, to do paper versus EDC. Several of the CROs that I worked, they. They still offered the paper option to clients if that's what they wanted. And it's only know recently that we've even fully made the switch over to EDC. So, yeah, we're just, I think just by nature, a very cautious industry, which, understandably so, given the background of the reason why we do the things that we do, or because of things that happened in the past that we weren't a part of. But at the same time, we do need to make sure that we're cautious in how we move forward with drug development. [00:12:44] Speaker B: Sure. Somebody was telling me recently that b two b technology is ten years behind consumer technology, and healthcare technology is ten years behind b to b. And I just sat there thinking, my God, I think that clinical trials are behind healthcare, probably. So. [00:13:03] Speaker C: I was just talking about this with someone earlier. And so there's a lot of different EH platforms, software platforms that are embedded at the site level in terms of helping the sites find patients. And this is for. It's been largely for oncology trials, although there's some other providers out there, too. But the sites have to sign up to be a part of this network, and then they get the software embedded behind their firewalls, and it allows them to more effectively screen their EHR for potential candidates. And so the thought was being, and certainly this was something that explored at other companies where I worked at previously, prior to joining Prokidney at precision for medicine, there was a group that was doing EHR queries, and we were looking at how in the major EHR systems and either providing detailed instructions to sites or providing the little SQL statement that could be popped into the EHR browser and hit run. But even with that, what I learned is that it's good at being able to identify patients who meet your major criteria. So it may whittle your list down from 50 potential patients down to ten potential patients. But you still have to go into each of those ten potential patients and do a thorough chart review. And that's largely because of the unstructured data and being able to look through that. And so that's where there seems to be limitations and where things are, I don't want to say hiding, but that's where in reading the progress notes, all of a sudden you realize that, oh, you know what? The patient's actually not eligible for the trial because they had this happen. But because it's in progress notes, it's not being filtered, it's not able to be caught during that query process. So I think those platforms still are really good at being able to help refine the list so that they're not having to search for everybody with, in our case, with type two diabetes plus chronic kidney disease. It can help narrow that list, but still, it's requiring a tremendous effort from the site to be able to go through that list and vet it. So, I mean, it's one of those things that the technology is just literally like, moments before I joined this, I was talking with somebody in the office and he's like, well, maybe AI will help with that. I'm like, it could. I am by no means a technology expert, but at the same time, I guess with that, what I've learned is that even though somebody can say we can do this, there's still limitations to it. And it's really trying to pick and see what those limitations are that really are impact, that could potentially impact. I don't know why we're so far behind. [00:15:55] Speaker B: There's no silver bullets in research. Right. If there was a silver bullet, if it was one thing, it would have been solved. Right. It's a complex system, and as a result, it's going to require a lot of very specific individual solutions that stack on top of each other. Now, I want to a little bit about sites. Sites are kind of like the gateway to the patients. How do you see sites as a part of this idea of making patients a real stakeholder and even the design of. [00:16:23] Speaker C: So I've been very blessed to be able to work with a lot of individuals who really are at the kind of the forefront of site centricity. Right. Let's do right by the sites. Let's make their lives easier. And I'm a big proponent of that, too. Not just because I worked at a research site and knowing what it's like to get charts and having someone pull charts and say, here, you need to review all of these to see if any of them are eligible for a study, it's a huge amount of time. That huge amount of time takes to go through all of mean. This is going back to my Detroit days, where there was one patient in particular. I remember getting his chart, and he had. So these were paper charts, so his chart was like this, and there were two volumes of it. And so I was going through, and I was going through, and I was like, it looks like he's eligible. I haven't found anything. And then literally, after I finally finished the review and it took a couple of hours to review it, I found the one thing that disqualified them for the trial. It's that type of thing. It takes a lot of time to do that. And then also what I want to be sensitive about, too, is that just because we think that as sponsors or as CROs, that we think that something's a really nifty solution for a site doesn't mean necessarily that it's a great solution for that site. Or maybe the site has something else. So being understanding of the technology that the sites are employing themselves, because during COVID a lot of sites started to implement their own technology platforms because they had more and more people working remotely, they had to figure out workflows to allow work to continue as best as it could. And so being mindful of that and trying to make sure that the solutions that we're offering make sense for that site, because I want to be careful that we're not adding more work to the site at this point in time. The studies are complex enough. We don't need to be adding more requirements to them at this point. So if we can help support the site and help give them what they need in order to find patients, in order to, if they need to have someone else contact the patient or help schedule travel for that person to come into the site, just something to help offload some of that work so that way they can see more patients. That's what I've heard from a lot of study coordinators and from research managers, is that they want to be able to spend more time with the patients. They definitely do not like all this administrative paperwork and everything else that we have them do. So more time that they can see spending with the patients. To me, that just kind of translates into better recruitment and better data quality for our clinical trials. [00:19:11] Speaker B: Yeah. One thing that we hear often is that when sponsors start their study, there's a forecast of all these patients that are already established at the site. And oh my God, it's going to be so easy because there are all these patients that are here, and inevitably it's never the case. Right. But then there are these patients who are not yet at the site that somehow need to find their way to the site. And even that there tends to be kind of like a breakdown in communications and an ability to kind of really connect the dots. I'd love to hear you talk about what you found to be successful in bringing those patients that are not yet at the site into the site that are doing the research and making sure that they're successfully able to show up and spend the time with the researchers that those researchers seemingly want. [00:19:54] Speaker C: Do you mean like patients who are not maybe part of that practice and then that know that's something? Brandon that to me has continued to be a challenge, is managing those referrals. And I keep reading different thoughts about the success of referrals from other physicians. Some will say that they are seeing these referrals happen, others, there's concerns about referrals and that type of thing. Generally, I'm not seeing, and the exception to this is what I saw with oncology trials, where there's a subset of patients that are very motivated and there's not any distinguishing features about these. There's patients who are very motivated and will actively seek out clinical trials based off of a biomarker or whatever else. But generally, I haven't seen that patients are even looking at clinical trials and saying, oh, yeah, this looks like something I want to do. And then trying to find the nearest site to them and going there. They usually want to talk about it with their physicians. And again, the greatest paradox that we've run across is that patients think that their physicians should tell them about clinical trials that are available to them, and then the physicians just, there's so many clinical trials going on. It's not first in their mind, and so either they don't know of the clinical trial or they haven't heard of the clinical trial that the patient is referring about. I think we lose a lot of patients at that level. And so it's not even patient awareness. It's also awareness from other healthcare providers that are seeing these patients on a regular basis. And those are family practitioners, general medicine, those physicians who are seeing them just for normal health care reasons, the family doctors and how can we better educate them so that they can then be able to refer patients in for clinical trials so that they have a familiarity with it? So that's something that, honestly, I have not seen much success with. I mean, even going back to when I worked at a pharmaceutical company, we were taking prescriber data, and we were trying to use that and saying, hey, we see you're prescribing our drug a lot, and we have a clinical trial that is doing this, and it's close to you, that generated, I would say, no results whatsoever. And so that's a tough nut to crack, is how we do that. And so my thought has always been, if we at least let patients know that a clinical trial is available, then at least we have a better chance of getting them in a clinical trial if they at least know that something's available. But I think there's still some hesitancy to discuss clinical trials with providers. I have a family member with type one diabetes, and I can tell you that there are a lot of interesting developments being made with type one diabetes, especially with cell therapies, for something that he would be a great candidate for. But when it comes time to go to the doctor, he doesn't ask about clinical trials and they don't tell him about clinical trials. So it's only probably by virtue of me being in the industry and getting updates through various newsletters that I even know that this is going on. [00:23:26] Speaker B: Yeah, I mean, I think that there was research published by toughest earlier this year specifically on this physician referral situation. And I think they said that something like zero, if physician referral is at something like 0.2%, it's just, frankly, really hard to get it going. And I don't know about you, but I'm not seeing anything that would indicate that we should believe that it should be ten times higher next year and another ten times higher the year after that. [00:23:53] Speaker C: Well, what's interesting, too, is that for a long time, people were talking about how it was, and this was my belief as well, that there's this hesitancy to refer a patient to another provider for fear of losing that patient to that provider. There was some study that I read come out, and they said, no, that's absolutely not the reason why they're not being referred. But I don't know why they're not being referred to. Why they're not being referred, then, because just to me, based off of the way our healthcare system is set up in the. It's. You have different networks, and here, where I'm at in, and, you know, we have Duke and Unc and wake med, and so with them, it's very rare that you have crossovers with patients, seeing providers in different systems. So I don't know why the referrals are such a problem and what could be helping with that. [00:24:51] Speaker B: I think you hit on it in the very beginning, which is, I think there's just so many trials that are out there that it's impossible, really, to expect a physician who's not engaged in a trial to be aware of it. And they just see so many patients, and each patient has their own set of considerations. So it's a big end to end matching problem that I think is, frankly, impossible for anybody to keep in their head. [00:25:13] Speaker C: And through all this, too, and this is going back to something earlier said about clinical trials in general, is somebody I work with, he always says, he goes, they're messy. Clinical trials are messy, and they are, things happen. And because through all of this, this sounds really harsh, a controlled experiment. We have the human element to factor in, and there's inherent unpredictability just in that, in terms of we don't know what is going on in someone's life, that suddenly they're not able to participate in a clinical trial anymore. They need to withdraw. And so there's things that happen in people's lives that impact all of this. And so clinical trials are messy, and things happen out of window. Visits happen, sometimes can't get a good blood draw from a patient, and so we're not able to collect those results. That's one of the reasons why I think it's why we are. And where we are is because we're working in an industry where we're heavily reliant on people who have normal lives. It's not like phase one studies where you sequester them in a clinic for 48 hours and where they're in one place, and we're at the mercy of everyone's lives. [00:26:30] Speaker B: And that's not going to change. [00:26:31] Speaker C: No, that's not going to change. [00:26:33] Speaker B: That's not going to change. That's just the reality of the kind of work that we're doing here. [00:26:36] Speaker C: It is, and that's why we do the best that we can with it, and we try to accommodate as best as we can with. And that's probably why we're also where we are in terms of not seeing the innovations in there, because it's difficult to apply one concept and think it's going to match all the patients and that this will work for all the patients, because it won't. You have to account for variability and you have to account for the unexpected. I mean, any project manager will tell you that they start their day thinking they're going to know ABC, and then at the end of the day, ABC are still on the to do list because they had, I think our unofficial model is expecting unexpected because we never know what situation is going to come up that is basically going to derail the day. And you're going to have to figure out how best to respond to this while keeping in mind the first and most important thing is patient safety, making sure that what we're doing, that the patient is still safe, and then also making sure that the data that we're collecting are high quality. So we have to make sure that what we're doing is best by the patients at all times. [00:27:46] Speaker B: Yeah. Megan, I want to change tags a little bit here. What do you think everybody's getting wrong. [00:27:51] Speaker C: Today that we don't think that patients have, but I think that in terms of just, there is too much variability. There's too many factors that we can't control. And so we have to go with the accept what you can control and look at what you can control and also build programs that account for that. Things are going to happen during your clinical trial, and you need to be prepared to be able to move and be flexible and be able to adapt quickly. So that's where I think some of it is that something that we're kind of missing the mark in is adaptability and flexibility. We all say that we're like, oh, yes, we're flexible and we're adaptive, but at the end of the day, when push comes to shove, when you're trying to implement new solutions or whatever, all of a sudden you're not seeing that it's as adaptive as what you think it is. We're right now mired in process, and we're mired in a lot of procedures that have been formulated due to inspections by regulatory authorities. And so it's a very CyA mentality. And this comes a lot from our vendors. They have these very onerous processes that often make it difficult to be flexible and adaptable and be able to turn on a dime. So that's where I think this is solely my opinion, that there is sometimes an over interpretation of GCPs to the point of being so restrictive that it makes it difficult to act quickly or to pivot. [00:29:45] Speaker B: Are we saying no more GCP? [00:29:47] Speaker C: Is that no, no, because GCP is inherently meant to be flexible and subject to interpretation. And so it's doing its job and saying, this is how you need to do things. It's the interpretation by various companies that sometimes get in the way. And in doing so, they make it too restrictive and too difficult to get work done and accomplished faster. There's lots of opportunities within our industry to do things better and I think we're just starting to scratch the surface with it. There's a lot of niche vendors that are coming out that are doing a tremendous job of doing some of the things. And because they're focused on one task, they're doing a tremendous job of delivering on that and providing us with meaningful feedback. We work with a group called Innovative Trials and they're tremendous in terms of what they're doing to help support recruitment and not necessarily the bespoke recruitment strategies, but really spending time and engaging with the study coordinators and talking with them and saying what's working, what's not working, what do you need in order to be successful? And they're spending that time talking with them and then providing us with that feedback, which they've really provided some meaningful feedback to us. In terms of, well, this site says that they need patient facing materials in their waiting room, translated into Spanish, and this site just says that they need a brochure holder. Just things like that, though. [00:31:26] Speaker B: If that's. [00:31:26] Speaker C: Going to be meaningful for the site, then those are things that we can certainly readily accommodate. But unless we hear it, we don't know. Again, I think there's also one of the things that I really have been enjoying seeing, and Brandon, I know you've been a part of this as well, is just the collaboration that's going on with different vendors and reaching out and finding the willingness to share information and figure out if there's a way to work together, to come together and put those pieces together, because up until this point, there hasn't been a lot of collaboration with the vendors. Everybody's just kind of stuck to their own thing. But that has been incredible to see, especially over the last year, is when I've really seen it, is more and more vendors are partnering together and saying, let's do this. Let's figure this out together. [00:32:22] Speaker B: Yeah, absolutely. I did want to circle back to the patient perspective here. One thing that I've been hearing a lot is that we need to improve awareness of clinical trials with patients. Curious, what have you seen to be productive in the space of improving awareness, improving access, making sure that more patients know that they should even be considering research? [00:32:45] Speaker C: There's two different streams of thoughts here because I always talk about casting the net. Let's cast the net wide and see what we can. If they know about it, then that's a good first step because again, I think a lot of people don't realize that clinical trials are available and that there is something. I remember opening the newspaper here back when I think there were newspapers, right. Some of our local clinical research organizations, they would run ads on Sunday and it was do you have, and it would list probably like twelve different conditions. If you have any of these, call us. And that was actually a pretty effective way because it was just starting off at a very high level of being able to do that. So I think that's been tried to be replicated in different formats, primarily through Internet searches, Facebook ads, those types of things. But when it comes to clinical trial awareness, I think there's something to be said for that aspect of it. In terms of where we've seen most interest come from is based off of search engine and those types of as a person is googling or you develop a Persona of what the participant looks in terms of their Internet habits, their shopping habits, that type of thing, so that it's more directed to the patient. We have seen some success with that type of methodology in terms of actually getting patients to go to a study landing page, click on the prescreen questionnaire, fill that out and then have someone follow up with them to see if they're eligible. Where we've seen less is with cold calling. If we were to use using a help desk or help doing those types of activities. Because I'm just as guilty, right? If I see a number that I don't recognize on my phone, I'm not answering that. There's that. And then also email campaigns don't seem to work particularly well either because I think they probably get redirected into a spam folder. Interestingly enough, we did see some return on mailers with direct mail, but those take time for those too. And I didn't realize this at the time, that you have to account for not only the time that it's sent out, but from the time it's sent out to when you might actually see people respond to it is several weeks and so you're not going to see those. So if you send them out at beginning of March, it won't be until probably April or so where you start to see any feedback. And that's just doing QR codes. So I think there's an opportunity more for keeping healthcare providers, keeping all healthcare providers informed about clinical trial options for their patients and accessibility there. But then also, I don't think there's anything wrong with letting patients know that there are clinical trials available for them as well. What I have heard from some vendors that we've worked with is that they have found Facebook to be the most productive in terms of that. And then trying to find those communities within Facebook has also been helpful. And then also I've heard a lot more about reaching out through to advocacy groups. But with that, the flip side of that is that I've also been hearing that the advocacy groups are so inundated now with everyone looking, it's getting a little much for them, too, and so they're having to be more selective. [00:36:27] Speaker B: Yeah, I want to talk a little bit about the email thing for a second. One of the things that at least at power we're increasingly starting to talk about is that it's not about your database that you're emailing, it's not about how big a database is, because at the end of the day, if somebody signed up with a database a year ago, they're no longer interested anymore. They filled out a form two weeks ago, they're probably not interested anymore. So it's not about the size of a database that you can email. It's really about the flow of current patients, the flow of currently interested participants. And the thing that we're trying to kind of emphasize now is just that sponsors should be thinking about who has the best patient flow in an indication, not who has the biggest database or registry or anything like this. It's who is going to see the most patients each week and get your study out in front of the most patients each week, each month. To the folks who are currently in the market, so to speak, for research, anything beyond flow is probably not going to produce results. And if you think about Facebook. Right. Why does Facebook kind of work? Well, it's an active flow of patients. They've just clicked an ad. They're in an active flow of, you know, there's an argument to be made that those Facebook patients probably aren't as engaged or aren't as interested as a patient who maybe went out looking for themselves and they're probably going to lose interest faster. So the time is really of the essence. But at the end of the day, it comes down to flow because Facebook is just another way to get unique patient. [00:37:59] Speaker C: I mean, that's it exactly. So it's something that there's certainly a lot of providers who are providing access to claims data that do that type of thing and kind of show you that you can track the referral pathways, you can look at who is seeing a larger volume of patients and maybe track that over the last six months, and then who is not seeing as many patients, so maybe they're closer to retirement, something along those lines. And so you are able to do that and checking that. But that would be an important aspect of that as well, is the patient flow, and I don't think anybody has a really good handle on that. Just my opinion, again, is really what that patient journey looks like, because the patient journey, again, is variable. It's not a bespoke pathway for every single person is following a to b to c. It's through different providers. That's something else. I think we need to really spend more time is understand what the patient's journey. [00:39:06] Speaker B: Absolutely. [00:39:07] Speaker C: Where we can intervene and say, hey, we have a clinical trial for you that may benefit you, and that goes. [00:39:16] Speaker B: Back to what you started with. Right. Which is, hey, patients have real lives, and clinical trials have to fit into those patients lives. I've had a few conversations over the last week with patient centricity experts, and they're all like, at some of these larger pharma groups, and they're all saying that the first thing they do is try to map out the patient's real life and understand what's happening in the real world for those patients. And as a result of the real life mapping, how does a protocol have to be designed for it to be feasible for that patient in the first place? [00:39:46] Speaker C: Exactly. Parkinson's patients are a very good example of that, because they take medication, and then depending on when they take their medication, they have a window of time where their symptoms are stable enough that they can function. So you have to take that into consideration as well. But that's one group. There's lots of other groups that are like that, too, that they have to take a medication, and then they have to wait for the medication to work before they can be able to be engaged or be able to get to a visit, that type of thing. So I think that's a wonderful first step, and I think that's something that we all need to do, is sometimes we're so hurry, and we're trying to hurry, hurry, hurry and get things done, that we need to take a pause and really think about the patient and think about their lives and what their daily life is like. [00:40:41] Speaker B: Sure. Yeah, absolutely. Well, Megan, I'm looking at the time and I'm realizing. [00:40:49] Speaker C: As always, Brandon. [00:40:51] Speaker B: Yeah. [00:40:52] Speaker C: It's always dangerous when you and I get on the phone because it goes by so quickly. [00:40:57] Speaker B: Yeah, this is going to be part, one of many parts in a series, I'm sure. Megan, any closing thoughts, any last thoughts on patient centricity, ways that you think the industry needs to change? Before we wrap here, I keep an. [00:41:12] Speaker C: Eye on things that are happening and wanting to see things. And to me, it's a lot of the things that I saw that looked very promising during the earlier days of the pandemic that I thought we were moving forward with have been disappointed to see those not work out as well as intended. I think there's a lot that could be done in terms of maybe keeping those thoughts alive or learning how to do, figuring out how to do these things better. The example I always give is that if I have to do imaging, why do I have to go to a main campus? Why can't I just go to an imaging that's five minutes from my house? Why do I need to go onto the main campus to do the imaging? So figuring out those types of logistics, I think, would be important. But we're an industry where we have to deliver results, and we deliver results quickly as possible. And in doing so, sometimes we don't have the luxury of really thinking through things carefully and realizing that by doing this homework ahead of time that it could help us in the long run in terms of our patient recruitment and then also ultimately engagement as well. So I still think there's a lot of work to do and we're headed in a good direction. We're definitely headed in a good direction. We just got to keep the momentum and keep it moving forward. [00:42:32] Speaker B: Yeah, absolutely. There's always more to do. And if we subscribe to the idea that healthcare is behind software and clinical trials are behind healthcare, then we've got at least 30 more years of program. [00:42:43] Speaker C: Yeah, probably 30 years time. We'll have this all figured out. [00:42:47] Speaker B: That's right. [00:42:49] Speaker C: Anyway, well, thanks again, so appreciate you. [00:42:52] Speaker B: Taking the time to have this. [00:42:54] Speaker C: Always my pleasure. And thanks again, Brandon. Really do appreciate it. [00:42:59] Speaker A: Thank you for tuning in. If you haven't already, please follow power on LinkedIn. Sign up for our live events and engage with us in the conversation. [00:43:09] Speaker B: We hope to have you join us. [00:43:10] Speaker A: Next time on power to the patients. [00:43:12] Speaker B: Take care.

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