Ethan Seville, Manager of Customer Engagement and Strategic Solutions at Slope,
sheds light on the formidable challenges clinical research sites encounter with sample management. Tune in as we discuss the importance of proactive advocacy, crafting effective SOPs, and fostering inter-site collaboration. Ethan also explores evolving trends and changes in sample management and the exciting potential for future innovations in the field.
Ethan Seville, Manager of Customer Engagement and Strategic Solutions at Slope,
sheds light on the formidable challenges clinical research sites encounter with sample management. Tune in as we discuss the importance of proactive advocacy, crafting effective SOPs, and fostering inter-site collaboration. Ethan also explores evolving trends and changes in sample management and the exciting potential for future innovations in the field.
Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks allows our partners and those that we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, and to learn overall more about our community. Today we have Ethan Seville, the manager of customer engagement and strategic solutions with Slope here to talk with us about the state of sample management and how clinical research sites are managing their samples and some of the solutions that Slope might be able to bring To this space. Ethan. It's great to have you with us here today. We'd love to learn a little bit more about you, your current role and a little bit more about Slope.
Ethan Seville:Sure. Thanks for having me. Jimmy. My name is Ethan and actually my background is exclusively in clinical research. I started as a research coordinator fresh out of college and like most people fell into the industry. I think that's the most common thread you hear from anyone in research. I was a research coordinator because that's the first job I found outside of college with a science degree and started actually an ophthalmology doing clinical trials, doing everything from drawing blood to processing samples to negotiating budgets and being a regulatory coordinator, travel coordinator and all the complexity that comes with the job of a research coordinator. From there, I moved into the rare disease world. So a bit of a level up in terms of complexity of studies, more samples, more protocols more chaos to go with it. I was at that time actually heard of Slope. I met the founders at an ACRP conference actually and became a Slope user. So for a couple of years, I used the platform extensively and got really familiar with it. And I, I really did fall in love with the fact that it was a platform that worked for sites enough to join the team in 2020. I've been with the company since, and I've gotten to, to grow with it as a Slope has grown, helping sites and helping our sponsors and CROs, all of our partners, tackle this, this really big issue of sample management. So, coming from the other side of the world, I, I, painfully familiar with the chaos that comes with the status quo of sample management. It's really exciting to be able to give back and give teams a tool that actually works and actually fixes problems like it did for me to our teams today.
Jimmy Bechtel:Well, I love that, Ethan. I think it's so important in our industry for us to experience from that side, exactly some of the things that you had mentioned. I share a similar background to you. I went into research right out of college, so I was able to bring some of those first hand experiences to the work that I've done previously in my career as well as, of course, most importantly, what I'm doing now with SCRS. So I think that goes a long way for the development of solutions like this and, you know, getting into that topic a little bit. Sample management is really one of the core components to clinical trial expertise. Execution. We can't do a whole lot without our samples, and they obviously have a huge effect on the data that we're collecting as part of that trial. So talk a little bit about the other components of execution that might play into that sample management, and how does that management then impact Some of those downstream trial operations.
Ethan Seville:Yeah, absolutely. And I like to look at sample management as kind of the meat of the execution sandwich. It's that middle meatiest part that usually has the most complexity and the most Places that things can go wrong, but you have to look at both sides of that sandwich. From the start I really like to think of inventory management as the first step in sample management. Without good inventory management of your lab kits and their components, you can't have actual sample management. One of the ways that I, I think about that is that if you have a sample down the line that you're trying to analyze and you're curious about why something's different about it, Maybe one of the questions you should be asking is what tube did this sample come out of? Was it aliquoted? What was the expiry of that tube? Was there a sterility issue with that lot of of tigertop tubes? If you don't know what inventory you used for that sample, Well, your sample management is kind of open ended, and that goes back to even preparing our sites to even execute a sample collection by having adequate inventory, while not overburdening them with too many lab kits, which is a whole other topic for a whole other day. But that's kind of the start of it, right? The upstream of sample management. But then you go to the other side of that sandwich, the downstream, you have all effects of that, right? Study planning. A lot of our sponsor partners talk about having to understand what volumes of PKs they've actually drawn so they can schedule their dose escalation meetings or schedule critical analyses and time points for that. If they don't understand what's been happening at the site or what's already at the lab or all that information is scattered, Well, then you don't have proper operation management because you're lacking that critical middle point.
Jimmy Bechtel:Those are really great examples Ethan. And just a few i'm sure right? We could probably talk all day about what various components of clinical trials are affected ultimately By sample management and what goes into play when, when doing that. But thanks for highlighting some of that. It really helps to give some background to the importance then of solutions that can help in this space. So let's talk about some of those challenges then. What are some of the more common sample related challenges that you've seen at the sites, both from your personal experience, but also then being on this side of the fence as well.
Ethan Seville:Yeah, great question. One of my favorite parts of my job is talking to our sites and I always ask them what if I had a magic wand and I could wave it and fix one problem with your sample management, what would it be? And one of the most common things I hear from research coordinators is lamenting the complexity of current sample collection schedules and this skews based on the types of studies we're working with. We're very involved with early phase oncology studies, rare disease studies, so we skew towards greater complexity. Of course, this applies to simple studies to where complexity comes more in the volume of samples to be managed. But when it comes to the modern visit, where we have more outcomes than ever before, more visits than ever before, more sub studies than ever before. Coordinators are just so burdened with the level of complexity for each visit and the tools that they're given, the things that they complain about the most that the tools that they're given are simply insufficient. They'll get a lab manual with maybe a nice flow chart, but that flow chart might be out of date, or it might be version one of three, and they're now on version three, but version three wasn't printed out and put in the lab or someone took it with them to another room and they don't have that flowchart available to them or the flowcharts inaccurate, which we hear more often than not the wrong color tubes in that picture. And it says orange top here and purple top here, or 4 aliquots here and 2 aliquots here and coordinators just can't keep up. The complexity has scaled past their ability to handle it. I will say that was my experience too. Back at site, we would get these novel length lab manuals and be expected to interpret them and execute on them perfectly every time. But it wasn't just one study we were running. We were running 10 at a time and each coordinator was responsible for knowing them to a T every single time. And we're on the clock, you know, you've got 15 minutes to spin down that tube to keep it within protocol. And if you're spending 15 minutes trying to find the page that tells you how to do it, well, that's a deviation right there. And that's happening day by day by day. And we're just expected to handle it. And I think that's a remarkable testament to the ability of our coordinators that they're able to at least keep it up so far, but they're struggling there. They're really bearing that burden of the chaos of increasingly complex clinical trials and sample sample management.
Jimmy Bechtel:Again, ethan, really great examples of some of the challenges that the sites are facing in not only modern times, but some of those challenges I remember experiencing at the site level back when I was at a site, and it really is that juggling of different trials and different sample management requirements and techniques and. And just making sure that you have things straight because oftentimes it's one or two people that are helping in the lab process those lab samples for for, you know, the smaller to medium sized sites and that act of keeping things straight so that we're not screwing things up, making sure that timing is appropriate for when various steps for processing that sample need to be done are all Very critical. And then you add on top of that, right? Layers of complexity that I'm sure we're experiencing in today's modern trials, especially specific disease states and various tissue samples and things along those lines. So those are some really great examples. What changes or trends have you seen speaking to some of the modernization of clinical trials around the way that samples are handled today? And what's causing some of these changes?
Ethan Seville:Yeah, honestly, like I was mentioning a little earlier, seeing the increase in complexity is probably the number one thing we've heard from our sites, what, what we've been able to observe. There are more exploratory outcomes than ever before. I know there's a big trend towards specificity in outcomes. There's also a trend that comes from the natural world of clinical trials, where once one drug gets approved by using certain outcomes or biomarkers. We really start to see other sponsors add those on maybe as an exploratory outcome right. But it adds to more samples being processed or more sub studies, right? That might be optional for a site to enroll a patient under. But then you, you've now added a new trend, right? An extra consent to handle for that patient for extra long sample storage. Even recently, we've seen a big chatter on tokenization of patients, which has caused a bit of controversy in the site world, where now we're trying to collect additional information about our patients to on the surface level, prevent duplicative data across patients enrolling, but that's now adding additional burden of data tracking to those samples. You know, what happens if they're giving consent for long term sample storage? How are we adequately tying that consent to the sample as it's being carried from lab to biorepository to specialty lab back to a biorepository in perpetuity, like that level of complexity because of the nature of the industry where we're getting more informations from our biomarkers is just becoming more and more critical for our coordinators to get that data in the right place and talk to the patients in the right way, I think, as we look for more outcomes, better science, we're getting more and more specific with the data we need to be tied to those samples, and that trend is only going to continue, right? As the science advances, we're going to get more specific with our sample management. So, what, what impact that has for our sites, of course, is, is pretty obvious. They're going to need to be able to keep up with that. They're going to need to be able to collect that data properly and have the tools they need to manage it. You know, if you think about the process of consenting a patient today, it's supposed to be ongoing and continuous as the study goes on. But The patient is not going to really think about the fact that if they gave consent for a sample to be stored in perpetuity, and now that test has been changed, or they're looking for an additional outcome, maybe they've finished dosing in that study a long time ago. Well, now we have an additional layer of communication that's required from that site to get back in touch with that patient. Hopefully they've not been lost to follow up. To to have that layer of communication is going to be key. That that again, another burden, another job that's being put on our sites. Our sponsors are ultimately going to be accountable for that to making sure that they're keeping up with their end of the deal. But it's just another layer of complexity that comes by advancing science. I
Jimmy Bechtel:couldn't agree more, Ethan. It's is really interesting. And if I was to summarize what you said, it's a it's a complexity, right? So we're talking about the pipes of samples that are being acquired from patients as well as their scientific questions that we're using those to answer, but also a quantity, right? Because you start to look at the standard sort of like you've mentioned trial related sample collections and then optional sub study related sampling. I remember back at the site we were doing a C diff trial where we, you know, gathered the patients post vaccination samples but also there was. That's an additional component that the patients could opt into that required some extraneous same processing and additional draws for those samples, and we kept them in the freezer forever and we shipped them out in batches. So it was like this added like you had highlighted layer of complexity is just one example, and I know that's one of several different kinds of forms that that can take, but again, also thank you for sharing the impact on the site because you're, you're 100 percent right. It affects their ability to execute that trial and it affects the amount of resources that is required of them. And ultimately then is something the sites have to consider, when it comes to their financial management as an organization.
Ethan Seville:No, exactly. And those are the exact type of scenarios where we see problems tend to pile up for sites because it's not part of the day to day task. You mentioned batch samples shipping, especially for a sub study. That's likely not going to be in the monitoring plan for an every monitor visit checkup, right? That'll be a Hey, once we get to that point, we'll handle it. And those are the places where our sites bring up the most red flags because they're saying, Hey, Hey, Well, we don't have time to handle it on a day to day. But if we don't address those issues early on, they're going to pile up. And now we have 50, 100, 150 samples in that freezer with very little accountability around them. You know, how many sites have sample storage plans and SOPs? Really few unless they're at a really large hospital or academic institution. Their freezer storage is, is really just what's in the freezer. Now is what we have. And when we need to find it, we'll open that freezer door and look through it. It's a really, really big challenge for sites. And when it's not. Part of the main study when it becomes optional, that means it's going to fall in the back burner. There are too many other urgent things for sites to handle. So it's a really, really big place where sites are even opening themselves up to risk and regulatory risk simply because it's not an urgent problem. It'll become urgent down the line only after time has passed. It's a really challenging thing.
Jimmy Bechtel:Absolutely. It's such an interesting I don't know if paradox is the right word, but interesting paradox for these sites. It's one of those things that falls into that category of you kind of don't know what you don't know when it comes to SOP and policy development. Related to that, you can do your best to have policies and S O P s in place based on that specific protocol and what would be required of you for that. And then, of course, based on the regulations. But until something happens, unfortunately, a lot of sites don't really think. In preemptiveness around those challenges that they might face. So getting getting your policies in place because a lot of what we look at in clinical trials is far outside of what one would consider as normal clinical sample collection and sample management. So even someone who's worked in a lab for 10 years would very likely encounter some really unique. nuance as it pertains to clinical trial sample management and things like you know, PK samples and some, some of the ways we handle our tissue samples and even the, just the way we process and store you know, fluid samples is, is just so unique in clinical research. So there's a lot to it. But I think the key takeaway right from your, one of your explanations there. Ethan is review, spend time reviewing and make sure that you have your policies and S. O. P. S. in place that would pertain to the management of those samples in that clinical trial.
Ethan Seville:Yeah, absolutely. I think sites. I think sites. Live and die by their SOPs, of course. SOPs are typically seen as instructions and things to train But if I could give advice to sites, it would really be to take control of your SOPs Don't make SOPs reactionary It's just the thing that you had to do because you had a CAPA issue and you had to write a new SOP Not that that's ever happened to our sites, but To be proactive and look to see how you can take control. You know your site best, you know your coordinators best, you know your patients best, you know your sphere. Take control of that. Write sOPs that empower you as a site to do your job best. So if that's an SOP with regards to sample management. Perhaps you've invested in a system to, to, to manage your samples, or you've made use of other tools. Obviously, I'm familiar with Slope sample management tools, which we do have available for sites used specifically for that reason. But whatever you're doing, write an SOP that says at our site, when we collect samples, this is what we're documenting. This is how we document it. This is the process that we follow to ensure samples go to the right place. So when you have labs that. Live manuals that come in. And your sponsors give you these lab manuals that don't have good enough information. Don't have good enough instruction. You have something to go back to and say, Hey, listen, here are our approved SOPs that have led us to be a successful site with a 0 percent sample missing rate or, you know, 0 percent delivery issue. Here's how we've done it, sponsor. This is what we need from our labs and your labs because the thing that sponsors don't hear often enough is feedback from sites on these lab manuals. Typically, what happens is sites would complain to their C. R. A. or they'll get stuck in these help desk loops from the labs that don't get that feedback to where it needs to go, which is Protocol designers and cleanups managers and the people who can actually influence the way that the study is being managed. At the very beginning, sites need to be advocating for themselves using their SOPs as that backbone to say, listen, We know how to manage samples at our site. Here's what we need to be successful. Here's what we've learned how to be successful. Let us do our job sponsors. And obviously it's very reductive for me to say, just write an S. O. P. And everything will be better. The point is that If sites advocate for themselves and use documentation like their SOPs as the foundation for that conversation, we can actually make some headway in the industry of streamlining sample processing and leveraging technology that harmonizes inventory management into sample management, into sample logistics, and puts power back to the users and keeps that chaos at bay.
Jimmy Bechtel:Ethan, I think those are really great examples of things that sites should consider when they're, they're faced with some of these challenges, again, you gave some good examples there, but did you have any other advice for sites who might be grappling with some of the challenges that you've mentioned?
Ethan Seville:Yeah, in addition to just being your own advocate, talk to other sites. you know, we Have an advantage at Slope of, of having a large site network. But one of my favorite things is to hear how sites have told each other like, Hey, here's how, what we did. We, you know, we're working on these studies and this indication, and this is what we found to be really helpful for us. Let, let us share with you that because sites aren't really competitive with each other. We, we work in a collaborative industry. So that's sort of site to site help. is really a big thing that I can't stress enough, that for me as a coordinator, getting in touch with fellow sites that were running the same studies, if we were having problems executing on a certain thing, or problems with, you know, biopsy processing that was really, really complex and we couldn't quite nail down the logistics of it, talking to another coordinator at another site was more helpful than a lot of the training we received from the lab because they were the ones that were dealing with the same problems. So talk to your other sites, find out what tools, what resources that they're using to help them and Go from there, share what works for you. We're all going to do better when we work together.
Jimmy Bechtel:It's a great piece of advice, Ethan, and one that I think we cannot remind our community about enough is that there's other sites here, there's communities within SCRS as a good example or within, as you had mentioned those that are using that a specific piece of technology or a solution and user groups along those lines as well. So I think those are really great examples. Thanks for sharing those. Ethan, we're getting to the end of our conversation here. It's been really great. Thanks for the insights around what, what we've talked about here with sample management, but can you maybe share in closing where you think the industry is heading in terms of sample management and just maybe a little bit about anything that might excite you about the future of that sample management?
Ethan Seville:Yeah, absolutely. Obviously, the science isn't going to slow down. It's only going to continue to accelerate and. Optimistically, we would have the tools to handle that complexity. Realistically, I think it's going to take some time, and we're going to have some growing pains. We've heard from more sites than ever that they've had critical issues because of that complexity. Lost samples, missing samples, samples going to the wrong labs. Our labs tell us the same thing, and our sponsors are kind of left holding their hands up saying, Well, what's going on? How can we fix this? The, the good news is we're hearing from more sponsors than ever that they have end-to-end sample management teams and initiatives to get to the root cause of the issue. We're hearing about these large scale, multi-year efforts to solve these problems and really get the key stakeholders all at the table. By stakeholders, I mean our research coordinators, our lab coordinators, our logistics coordinators make their voices be heard. And that really does excite me because the more we're able to interstakeholder collaborate, the better the solutions we're going to work with are going to be. And, and hopefully that, that trend continues in the next few years. So we can not just handle the complexity, but come up with solutions that are future proof, even as the science continues to grow.
Jimmy Bechtel:Ethan, it's great to have you involved in an organization with that mindset, because I think that's not as common as I think the sites would hope. So more power to you all. Thank you. And thank you to the Slope team for advancing this important work and having a solution in this space that is built for sites. It's it's really refreshing to hear and great to hear someone with your background and knowledge on the team That's helping develop this. So also thank you for being here with us today. Thank you for sharing your knowledge It was great to have you, great discussion with you on sample management Absolutely, make sure that you register for upcoming summits being held throughout the year by visiting our summit page on our website my SCRS.org While you're on our website, be sure to also check out other SCRS publications and resources built for our community in the publications and member benefits section of that same website. We appreciate your participation in today's program and look forward to having you join us for more great content coming soon. Thanks for listening.