PODCAST: Planning Around a Respiratory Season That Won’t Hold Still

Emily Friedland: I'm Emily Friedland, VP of Clinical Research at DCN Dx, and this is the Expert Insights podcast. Today we're talking about respiratory studies and how to plan for a season that no longer looks the way it used to. At DCN Dx, we run these studies as a CRO, which means we spend our days identifying and managing sites. But the person who sees what a protocol does once it reaches the front door is the site. So I've asked David LaMarche of ERA Health Research to join me. David, welcome, and please tell our listeners what ERA does.

David Lamarche: Thanks, Emily. It's a delight to be here. So ERA Health Research is a clinical trial network. We have sites in the Washington state area and in West Texas, and we have been running, in addition to IVD trials, many other trials for the last seven years or so. We are seeing a lot of changes in the respiratory trial space, and so I'm excited for us to be able to talk about that today. My responsibilities at ERA are for strategy and growth, and so I spend a lot of time talking to CROs and sponsors as we look forward to how we're going to work.

Emily: We always enjoy talking to you about that. David, I wanted you on this particular podcast because respiratory is where we are really seeing the gap between a good plan and a bad one, and you see it really close up in a way that sponsors don't always. So I'd like for us to talk a little bit more about it. Like when we've talked before, you described how much harder respiratory season is to predict than it was a few years ago, especially earlier in the pandemic and prior to COVID, when flu was very regimented in season. From where you sit, watching patients come in, what's changed about when and how people show up?

David: Yeah. It's a really good observation. So ERA being located in Washington state, we were kind of at Ground Zero. The hospital that we were connected with at the time, and where some of the providers that our PIs and our organization work was the hospital where the early kind of crisis hit, the first 25 or so people who passed from COVID were at that hospital. So I think the experience we had in the community around the franticness for can I get tested? Can I get vaccinated? Am I sick? Worrying about, you know. Remember the bubbles we had that we spent time together. And so the testing scenario was preeminent in everybody's mind. And I think we've all seen the evolution of that. You can go to any drugstore now and get 14 different over-the-counter on the shelf type of tests for COVID, flu, RSV, a bunch of different things. And so I think, you know, the transition from that space has really impacted the way we perform trials. We could have screened thousands of people early on in COVID. And now it's really, really difficult because when you ask, how do they show up? A lot of times they just don't. They're like, yeah, I went to work. I think I have COVID, but it's it's like when somebody has a runny nose. It's just changed so much in that space. So I think that's the biggest scenario or the biggest starting point of challenges and clinical trials with. We've seen a shift in the way that patients behave. And we also know that flu and RSV show up still in the wintertime. Still standard, still shows up on when the kids go back to school. We get RSV, October hits. We start seeing flu sometimes a little bit later, sometimes a little bit earlier. But COVID isn't necessarily keeping to the winter calendar anymore. Maybe it's outsmarted us a little bit.

Emily: The CDC's surveillance data shows that COVID is peaking now twice a year, once in the late summer and once in the winter. From your side, from the site side, do you see that second wave, and what does it do to a study that's built around just the winter season?

David: So I think the challenge, it is evolving. Last year, so 2025, we saw a huge spike in the kind of the June-July period. Initially, we were all kind of caught off guard. We are embedded in a couple of urgent cares, and so we start to see that really quickly when it starts to show up in the community with people coming in sick. The rates of infection in our community from the June-July spike was significantly higher than the winter, you know, December, January or February spike. And so it did create some real differences. And I think we'll talk about this in a little bit about how do you get ready for these types of studies. Nobody was ready. We had a couple of studies that were lingering and were still kind of opened. And all of a sudden, you know, they're making hay on finding people. But other folks who were surprised by the fact that they missed the biggest wave of the entire year.

Emily: With each respiratory season kind of changing a little bit, and COVID coming end of summer, maybe in the winter, what would your recommendations be? Or what is the risk for a sponsor who is building their trial plans and their protocol based on last year's schedule?

David: And I think it's a multifactorial answer. Right. Because, you know, it used to be you had a COVID study, and so you were looking for COVID patients. Now you want a study that has COVID, flu A, flu B, RSV, maybe even rhinovirus, right. And so the complexity of these usually lateral flow tests is just incredible. And so I think trying to figure out from a sponsor standpoint of how much do you need of each type of strain and infection type really becomes a huge challenge. I think the other thing that happens, and we'll talk more about timing later, but if the sponsors are waiting based on wastewater data or community prevalence from, you know, a Department of Health, they're going to miss the ball. And so very often that wave, I always think about this from like a surfing analogy. Right. It's like as the wave hits the shore, they're like, yeah, that's the one we want to be on. And it's like, well, yes. But the problem was you weren't out in the water and ready. And so I think sponsors have to think wildly differently than historically what they've done. It's not a we think it'll show up in October, so let's kind of get ready in August. I think it has to be much more proactive and collaborative.

Emily: Yeah. And even if you do look at those CDC charts, which we do, obviously every year when the sponsor comes to us, I mean, the peaks and valleys don't necessarily overlap from year to year. Right. CDC puts out their past five years data, and you'll see those different spikes of flu and RSV and COVID across the year that really don't have it matched up for years and years. Now with these studies that enroll prospectively, you have to catch fresh positives as they come in. This is especially important for our point of care and over-the-counter studies where it's all comers, whoever enters the door, we need to approach. So there's no way to manufacture good season, or target positive patients from prior tests or anything like that, which we definitely get that question a lot. Like, can't we use their point of care? That's a whole separate issue, right? Studies enroll in the winter, but the work that decides whether it succeeds happens months earlier. Walk me through it. When does the planning need to start for these studies?

David: Yeah, and maybe I could dial the lens out just another click and say, I think the assumption that the sponsor or CRO that's supporting that work essentially picks a date and says, this is when we're going to do this, might not be the most effective way. I think what has to happen is sponsors, CROs and sites have to collaborate together. There has to be a level of mutual trust and belief in each other that they'll do the right thing at the right time. And so I think that you'll probably ask about the length of these studies at some point. But I think if it were me, if I were building this from ground up, I would say, let's get in a room, let's pick a date that we're going to have all of the IP ready to go. We know it's quality checked. We know it's, you know, whatever it might be, and it's at the sites, and essentially the sites who are watching the people walk through the front door and starting to see this slow, you know, it's like, oh, we had no positive codes last week, we had for this week, which was not a lot. But it starts to say when somebody shows up symptomatically, it's time to start testing and we don't have to do 100 that week, but maybe we need to do 5 or 10 with people who seem most relevant, instead of waiting and waiting and waiting and then getting the green light. Because again, some wastewater data at Department of Health data, whatever it might be, has shown enough value to someone to turn it on. I think it turns it on its head a little bit. It says, we're partners in this and we trust you, and you are the ones that are seeing when that's, you know, ready to go and go ahead and get started and start, you know, gently. But let's see if we can start catching the front end of that wave. Because if you do, then it's going to shorten your season because you're going to get your collections and you're going to actually get on the front end of the wave that I think is easiest to identify.

Emily: I think a lot of sponsors are, you know, possibly also in their development phases and are worried about whether they're going to have product ready. Right. But even with that being true, let's make it a little bit more concrete about planning, because there's no harm in planning your clinical trial even if your product is in question. Right. We've done that from the sponsor side. I was the sponsor for many, many years and we're always ready as a clinical team to put a hold on a trial because product isn't ready yet, and that's a risk we should be ready to take. If a sponsor wants sites enrolling by the time flu picks up, what should be happening in the spring or three months ago? What should people have been doing? What should we be doing right now? From your perspective, from a site perspective, and by the time the fall comes around, September comes around, what should we be doing?

David: That's the right model to begin with, right? Historically we've talked about this in July, August, even September to say, hey, we want to start a study in 60 days. It can't work, right? It just doesn't work. So I think in the spring, you're identifying sites that you know are going to deliver. You go for urgent care sites versus primary care. As we've seen the shift away from primary care for people coming in to get assessed, because again, the concern around the disease state itself is so much lower. The infection is so much lower. So I'd say look for urgent care sites that have demonstrated, you know, really strong, robust enrollment over the last couple of years as they've weathered this shift. You need to build an established algorithm by which you work with these folks to say, okay, if we can put IP in place mid to late summer instead of mid fall when you might already be passed away. What is the process that we're going to agree to on when you start studying? If we give you the green light now, which I say we should, we trust you. We're going to monitor. We're going to follow through. You're not going to do a ton of studies and get no positives, right. But understanding that you're going to get the front end of the wave. And so if we give you that, one of the agreed upon kind of processes here, and then I think, you know, September, October, this is when you should be thinking, hey, right. It's not now we're building the budget and now we're trying to get IP shipped, and now we're doing cycle business that's been done months ago. And so now it's just is there enough IP? Is there enough materials out there for you to do this. And then we just continue to monitor right as we see peaks and starts to fall. You know, maybe it wraps up in September or October. A couple of years ago we saw COVID hit really hard late August, September. By mid-October it was gone. If you're trying to roll out in mid October, should just not even ship, you know. So I think that the issue really is build and establish the structure. Trust the site's front. Load the product so that they can be the ones to say, hey, it's happening in my community, right? It's not done in a vacuum. We trust each other, you know? But I would say the earlier you can start, the better if you're trying to hit a particular time period during the calendar.

Emily: Yeah. I agree with you from a CRO perspective. We do see clients, and I totally understand why this happened. You come to us September or October and November with a protocol. And, you know, you might be able to get your enrollment in that time. But the challenges of finding the right sites, making sure sites are available and you're not competing, and making people comfortable with product at those sites is a long process. The study designs for these studies are not overly complex anymore, right? They are pretty standard. Now we know what they should look like. There are definitely products that are more complicated or complex, or we have to take certain things into consideration. But in general, the number of patients you'll need, the number of sites you'll need, the number of positives you'll need are pretty well established. And so I agree with you, from my perspective on the CRO side, I would say in the spring, I'd love to see your study design, even if it's in draft clinical plan. And then you should have your CRO selected in the summer. Really, if you want to get to the head of the pack, that's the ideal time. Obviously, we will entertain people all the way through the season, but there's risk associated with that, right? And there's risk in finding sites like yours that are well qualified, know how to get the population and have experienced doing these types of studies. Speaking of timing, we've talked in the past about timing of product, and you've mentioned IP a few times here. How does the timing of getting the device into the coordinator's hands affect what you see when the first positives come in, and is there a case for putting it in front of real patients before peak seasons?

David: Yeah, 100%. If we rolled this scenario out to anything else. Right. If we decided that, you know, at our favorite coffee shop, we introduced a new espresso machine and we gave it to the barista, the, you know, five minutes before the shop opened. Right. It would be chaos, right? It would be a disaster. You know, half the coffee wouldn't come out right. Whatever it might be, I think that getting an opportunity to get the training up front, it strikes me. And what happens very often is we, you know, we'll get 3 or 4 devices for point of care. We have placement, urgent care. Three of them were great. Kind of. One of them can't get connectivity to the Wi-Fi. We can't get, you know, it'll process one. And then the second one, the machine doesn't result because it's too hot or, you know, it's just there's all these different scenarios in this space where I'd say having somebody understand what the workflow is, getting some like hands on, making sure everything works so that you've done your training, you've run through this. I mean, if you have to do a few extra tests upfront or if you ramp slowly, it's an advantage to everybody. You're going to get better results. Your machines are going to work. And if we're having problems, probably everybody else is having problems too. And so they might miss a lot if they just try to push everything out at one time and just trust that everything will go smoothly.

Emily: Yeah, having a coordinator spend time doing troubleshooting during peak season is definitely not where you want to spend your time and money as a sponsor or as a site, right? We're missing positives or patients that can contribute to their studies. And I think also the advantage, as we've discussed in the past, especially in point of care scenario where we're not allowed to train anybody how to properly use a device, and especially with more complex point of care systems with automation that are a little beyond kind of your standard manual read lateral flow test, even those have nuances as well. Having your coordinator test a bunch of negatives at the beginning. If something gets screwed up or you notice that product isn't working properly, you're not losing the most valuable participants in your study. One of the most expensive things that can happen in a respiratory program is running out of season before you've enrolled, and having to come back for another year. The bar is higher than it looks, because sponsors usually need comparator confirmed positives and not just symptomatic patients. What causes a study to run out of runway in your experience?

David: Well, I think again, just not to rehash everything, but the delayed start, right? So if you get on the back end of the wave, you're diminishing returns right from day one. And I think that's, you know, fewer and fewer coming in. And sometimes it can feel like a cliff. We saw 32 people last week. We saw four this week. And so I think that's at times one of the big challenges for that. So the starting time is obviously key. Delays or pauses in the study, from a site standpoint, there's nothing worse. Quite frankly, I think the other piece is just understanding how difficult the protocol is, not from a study complexity. But, you know, if I want some pediatric patients and dad or mom or, you know, grandparent, caregiver, whomever it is has two other children in tow, and we're saying, hey, we'd love to, you know, do this. How much time is in between the tests? Right. I mean, the study design, the protocol design can make it really hard to enroll people. Sometimes they're like, I've been here a half hour, I'm not staying another 45 minutes with two other kids who, regardless of whether they're sick or not, or whatever the scenario might be. So I think understanding the efficiency of your study protocol can really drive the length of time it takes to enroll the people. I think those are the key pieces. Right? Timing, IP, pause kind of go together. And then the complexity of the protocol from a duration standpoint, more than you have to juggle seven things at one time.

Emily: I'd really like to talk more with you about the start-stop nature of some of these projects, and how that affects how a site functions when enrollment toggles on and off, which we get asked to do a lot. Oh, the positive rate seems to have dropped at the site, we want to put them on hold until we see that the rate comes back, but we're not actually monitoring the rate, we're asking the site to monitor the rate. Right. So it's a little bit of a complicated conversation with the site when we do that, when we're asking you to switch on, switch off as a site, or if we activate you, but then we say we're not going to let you start testing at all until we see positivity rates start picking up. What does that cost you from the site perspective? In practice, in staff, in readiness, and in patients you can't get back?

David: We had a leadership meeting probably three months ago, after this last season, and this last season, the COVID never arrived in our communities. I mean, it really didn't. Saw lots of Flu A, gobs of Flu A. I mean, like we were in the 50s as far as the flu percentages for people who got tested from a standard of care standpoint, 50% plus. It was just crazy. And sick people who were sick for a long time. But, you know, COVID just never showed up. And so there was this pause, start stop, start stop. And you devote staff to this work. And ideally our staff, particularly in the urgent cares, as long as they're hopping and busy or doing six of these a day, because the average is about 45 minutes to an hour with a complete documented work done. And so if you can't do that, then you start to say, okay, what am I doing? And it's a day where there's two or the day there's one. You start to get yourself upside down really quickly in these studies, from a cost and from just a revenue opportunity standpoint. Delegation logs are kind of the tail that wags the dog. How many people can you put on a delegation log? How often do they have to do it. There's so much to remember. There's so many different components that, you know, if I'm going to not use these staff in doing this work, and I have them dedicated when things are really cranking, where else am I having them work? And if I start to pull them that direction, I certainly can't just hop back up to this side. The other piece I think that's really, really difficult is you are constantly notifying we're starting, we're not. Right. So if it's an all comers study where people are coming in, it is what it is. You're kind of with the flow. If it's not an all comers study, we can advertise externally. They come in and we swab them, that start stop, start stop, right. It's like I've got people calling for another week, but we're done or we're paused or we don't know, are we? Maybe next week, who knows. And then you're also communicating with your MAs, your physician staff. So it's brutally difficult. It's like managing a reverse sick call scenario. Right? Where like where do we put everybody, or boy, we need seven more people. So I understand the process from my lens. The slow roll versus the pause is actually beneficial because it keeps the conversation alive. And you probably, in those cases are going to get the most symptomatic people coming in typically. Right. If it's not in an all comers where people are out there and aware, or if your providers are aware and they're like, you know, I know positives make a difference or whatever, it's an all comers, and this person, I could have said, yeah, come on and see us. The other person may not think the conversations around that I think flow much better when it's just kind of always running. But we might say, hey, we'll probably only do a half a dozen versus 25.

Emily: I really appreciate that thought pattern, David, because, you know, we're always trying to kind of explain to sponsors, and I understand the instinct to want to control your budget and manage costs in your study. We absolutely want to do that. And frankly, sites also want to do that because they want to work with you again. And I think sometimes we lose track of the fact that we have people at the clinic site who are caring for patients, and that's their primary purpose, and that the start stop of research is both interrupted to the care of patients, but also can affect quality of your study, can affect interest at the site for participation in the study, because they may feel, especially if you are frequently pausing work, that this is just going to get paused again later. And why put as much effort into this as I can into, frankly, just caring for patients? I do hope that we can all be a little bit more empathetic to how our sites may feel. If on my daily basis, somebody came to me and said, Emily, that project's going great, but today I want you to stop and do something else. And then three weeks later they came back to me and said, Emily, I want you to pick up that project exactly where it was and get going. It's going to take me a little while to get going again, and I may have less vigor for that project, right, and may have to relearn it and make mistakes along the way. And so I think we all would feel off kilter if we were to be stopped and started on projects, and understanding that that can affect the work in a site as well. If the goal is to finish in a single season, what does the sponsor have to get right upfront that makes that realistic?

David: The point of care machines have to work. That's an interesting one. I can't tell you how many times I've had to send back a machine that, for whatever reason, is not functioning, and that it takes some period of time to get another one. You know, the worst case scenario, just like the intended pauses, are the unintentional pauses of, okay, we're down to nine kits. We're going to go through those by 3:00 today or 1:00 today. And then what do I. You know, I've got patients I'm going to see tomorrow. And are we not seeing those patients for this? I mean, like, you know, so I think the steady IP is definitely something that's important. And then again, I think the slow roll versus the pause makes a big difference. The continuity of the individuals who are performing the research, as well as just the general conversation in the clinics or urgent cares. You know, it allows us to be more efficient and to continue to achieve those targets that we've got out there for these numbers, but give the sites the ability to turn on when it's time. And it's a collaborative conversation. We can submit tracking data on a daily basis, whatever it needs to be. Let's work together to build a system that trusts that we're going to do this, and not from some third party that's delayed by some period of time. So start when you should start. Make sure that all the resources flow that we need to flow.

Emily: Let's talk a little bit more in detail about study design. Some study design choices look fine on paper, but make your day really, really hard. And one of those things that I know you feel very strongly about is same day shipping of samples. Explain that one, because I'm not sure that everybody always understands why that can be a challenge.

David: So we have studies that ship with the two organizations that do this, FedEx and UPS. We are in the Seattle area. It's a little different in our West Texas just because it's a much more compressed geography. There are two places UPS you can ship to, but anybody who knows Seattle knows traffic in Seattle is lovely. So we can drive about 45 minutes from our office to a UPS courier place by four. I think we have to be there by 4:45, or even more fun, we could actually drive it to the airport by 5:30. The airport, most days, probably a little bit more than an hour. The other location, 45 minutes to an hour. But here's the problem. If you start rolling that backwards, right, you have to get it packed. You have to get it in the shippers. You have to do all the paperwork. You gotta get everything done right. So let's add another hour. So if I have to be there by 4:30, let's say to cut it clean, that be done by 3:30. I probably need to see my last patient at two at the latest to get it done by three. And that's probably pushing. It's probably 1:30, 2:30, and gives me. So now I am in the first half of the day and maybe one post-lunchtime visit, and then I'm done. And so, you know, we get pressure like, hey, there's lots of volume in the community, let's go, let's go, let's go. And so we either try to run multiple people doing the same study, or we've got this such compressed day that now I've got people who are more concerned about shipping time than anything else. It's the tail that wags the dog. Worst case scenario, UPS tells us we'll be there 3:30, two hour pickup, but then no driver, and then it's 3:45, and now we're like, okay, short straw gets in their car and drives for an hour. Right. And hope to God we make it, because we've got, you know, 19 samples here that we got to ship. Yeah. Study design, if we can ship multiple times a week, if we can, you know, 2 or 3 times a week, once a week, whatever it is. But it doesn't have to be daily. Everybody's happier. Not everybody wants to come in in the morning, right? If you have the flu, if you have COVID, you wake up, you know, and you're like, I'm not doing anything. I don't even want to go get a glass of water, right? Let alone, oh, let me go see my physician. Right. So that afternoon window sometimes is a lot easier to get people into than the morning window. We want to make sure that we're having a broad cross-cut of time to be able to see these folks, and we want to be able to do it in the late afternoon as well. And that same day shipping makes, at least in the Seattle area, almost impossible.

Emily: We also talked about the after-school rush, right?

David: You miss all of those kids. They stayed home from school today because they weren't feeling good in the morning, and it's gotten progressively worse. Now mom and dad have to, you know, kind of rush them home, or they were sent home from school sick. You know, that's just parents' time to take kids places, right. They've got that time already, you know. We miss all of those. I would add Saturday receiving, right? Because then, then I'm stuck on Friday and the same day on Friday. But if you don't receive on Saturdays, there's nobody to catch it.

Emily: Laboratories, you know, they have their own issues with receipt on Saturdays as well. So for that core lab testing, for the comparator testing, you know, we all deal with FedEx and UPS. But frankly, courier service on Saturdays is patchy at best. Even if you pay for a first delivery Saturday, and I have a lab that just consistently for whatever reason, the courier does not make it there on Saturday morning. And then you're losing that sample if you don't have the stability associated with it. Right. And we will be careful here, because we do know that whether you can freeze the sample or refrigerate it for a period of time is an assay-by-assay validation question, not necessarily a choice the clinical team can make. But when an assay does support it and the protocol allows the site to freeze and batch instead of same day shipping, what does that open up to you?

David: Frankly, everything. If you have to ship it same day, you're going to lose probably three hours in the afternoon. You're also probably going to lose Fridays. When we think about when people go to urgent cares, I need to get seen. I don't want to go on a Saturday with everybody else. I'm going to try to go for it. And so I think there's an opportunity there where you get for half days or for 60% windows, and that's it. And so I don't know how much that would really bias your population of samples, but I do think there's something there. It just allows us to be more flexible, you know, allows our staff to be dedicated to that work during the day and be able to do it all day long, versus, okay, you got to stop, and now you got to race around. And there's all this pressure on the staff that's just different too. It's like everybody's looking out the window for the FedEx or UPS guy. Right. And again, they're human too. So she or he may not be able to make it for some reason, and they let us know. Fine. But it's just it creates chaos in the process. And I totally understand some studies that can't support that. But when they can, there's no way I could more strenuously recommend it.

Emily: This isn't an investigational issue. This is an issue for the central lab comparator test. I mean, unless your test that you are swabbing for is a central lab test, right, and that's the IP. But the central lab comparator test issue, knowing the limitations of your comparator test before you develop your protocol and really explaining that to the sites. And sometimes it does come down to we're trying to game the system a little bit by picking a comparator that FDA will accept, but maybe has like better sensitivity or worse sensitivity than another comparator product, and we want to kind of compare our product to something that's going to be advantageous for us. Right. But there are other things to consider in that selection process. As we're discussing, which talking to your sites, talking to your CRO can help you make that determination, you know, and doesn't have to actually be written exactly into your protocol, just an FDA cleared product. Right. You can make that determination as you discuss with your site what the best workflow for the sites is, and then you can kind of make decisions around what that practice will look like then.

David: And I would say from a site standpoint, it's more expensive for us to conduct same day shipping studies. Absolutely. Right. Our revenue window is diminished, and it takes more time and effort to ship every day, so our budgets are more expensive. And if I have just, from a staff sanity standpoint, if I have two similar projects and I'm picking one of them, I'm going to take the one that allows not same day every single time.

Emily: Let's talk about the device in the coordinator's hands. You've said that experience with the device before the positives start coming in changes everything. Why does this early hands on time matter so much for the quality of the data?

David: This is the first question we typically will get. How many untrained operators do you have? And making sure that we have sufficient numbers, always dependent on how many they want. You know, we want to make sure that we're delivering the best results and that we're adhering to the protocol, and that the staff have a clear understanding of how things work. And so over time, it's just like any other point of care device that somebody is using in a clinic setting. You know, the more time they spend with it, the better they are using it and making sure that they're not mis-loading the cartridge, not making, you know, whatever it might be. Having the staff have that opportunity to ramp in slowly, you know, if they're getting some negatives, whatever it might be, early on, when it gets time to start getting, you know, the higher volume where they're pressed for time a little bit more, you're just going to get better results, and it's going to increase their satisfaction. Right. I mean, I think, you know, when it's an untrained operator, right, there is some understanding that here's the manual, you can look at the manual. Right. But, you know, it's kind of a self-taught thing. But I think for all of us, right, we want to do a good job and we want to make sure that we're doing things correctly. And so it's an intended use. Right. And that's why we're using these settings. That's why we're using these operators with these CVs and backgrounds. And so having them be able to use these devices as well, I think is part of that process.

Emily: Say a little bit more about the link between operator experience and result accuracy. From the site side, what's the difference between a coordinator who's comfortable with the device and one learning it on their first real positive?

David: Well, I have not been that person before, so that's a little bit of, uh, look over shoulder, uh, scenario here. But I think, again, you know, it comes back to our key responsibility here, outside of patient safety, and these are, you know, fairly non-invasive tests, although sometimes those swabs feel like they've gotten to the top of the brain. Outside of the safety component, we want to make sure we're delivering the results that make a difference. That when people go and buy these tests from whatever store it is that they buy it from, that they're getting something that's really going to make a difference for them, that they can trust that, hey, if it shows that I don't have COVID, and then I don't have the flu, and I'm going to see my grandmother on Thursday, I can feel confident about that, and not worry about it. So we feel a decided responsibility. One of the lovely things that we get routinely is we get feedback from sponsors that have gotten their 510(k) on devices or whatever it might be, in notifying us, hey, this has hit market, you know, and we sit down and we talk about it as a team and share it with the staff, who are a big part of that. Right? We contributed a chunk of the study results that made a difference. And so you have to bring more folks on, right? You're always training new staff. You're always watching people. We had a year where we had a few people who were, I think, longer term rock stars for us, med school, PA school, nursing school. Right. We love it. But you're bringing new folks on. So helping to train the next rung of staff, I think, is really important. But having operators who, you know, are going to deliver quality results that the sponsors and CROs are dependent on, you got selected for a reason. The test may or may not work, but making sure that you're doing it right and having that experience, I think, is key in everything. And that's why we see sponsors come back time and time again.

Emily: Yeah, and I think this also goes back to our earlier conversation about getting product into the sites' hands ahead of peak season. You know, in advance of even when we're seeing a lot of COVID around. Right. So that they do have to self-train. There will be negatives. You still need negatives in your study. They're not being trained, but they're self-training to a level where they're comfortable with the use of the device. When the clinic picks up and those sick people are coming in, and they're under pressure to both treat and test for research, nobody's quality, either on the treatment side or on the research side, gets compromised. I want to close with you on something you feel strongly about, and I want to get the nuance right. It isn't that a study needs to have a site network attached to it. It's that the sponsor and the CRO must work the season through with their sites, the shipping, the freezing, the device, the windows, all of it. If they haven't done that, they haven't really involved the network. Make that case for a sponsor who thinks of sites as something you line up at the end.

David: You know, it's funny, because as a site network, one of the things we do sell is you're going to get the same results from each site, that we have centralized regulatory, we have centralized oversight, we have accounting and contracting and all of these things. And I think the more and more things are electronic, the more you can have that real time oversight from a centralized location. But at the same time, I think if you look and say everything's going to yield the same, you're going to get pretty frustrated, right? Which is why I think you have to step into that collaborative relationship. I mean, if it's simply transactional, you're going to get transactional results. And then I think if you're frustrated by it, the site's response can be, well, great, pick another site, you don't care about us anyway. You make broadcast decisions, or you don't realize that, you know, when we look at our Washington sites and our Texas sites, those windows of disease burden are dramatically different. Once it hits May, 100 degrees in Texas - we just had a strep study that somebody was like, hey, could you guys do something like in June or July? I'm like, not here. No, there's no strep. Whereas in Washington there's still a little bit floating around. Right. So I think having somebody that can titrate and adjust and see it as a collaborative partnership, but kind of, each significant one has a little bit different interface and a little bit different connection, is going to be key if you want those results. I think if you don't, that transactional thing is going to extend your study time, right. You're going to see that roll over from one season to the next, because you didn't get what you needed, started somebody too late, shut somebody down midstream because you thought they were whatever, and there wasn't a conversation. We want to do well as a site. I want to reach the point with every sponsor and CRO that I work with, when they contemplate a study and they look at us, if it's in our kind of wheelhouse, they would say, gosh, I wouldn't even consider doing this study without them, because I know they're going to deliver the results. So they're going to be collaborative in the sense that if something pops up, we're going to have a conversation about it, right? And if they start to see, we do this with sponsors, we would say, you know, we saw 20 last week, we saw eight this week. We don't know if it's just a trough or whether it's the cliff. And so we'll reach out at the end of the week and tell you where we are. Right. And we will almost self, I self-paused on a couple of the ones this year, where I just called and said, hey, you don't want us to do this anymore. I'm just dumping in negatives, there's nothing here anymore. So I think those are the kind of conversations that are going to allow us to come together, versus just kind of this blanket kind of layer across. Everybody gets treated the same, everything gets kind of done the same.

Emily: When a sponsor and a CRO and a site network are planning together, what are each of us doing, and what's the sponsor's contribution to that?

David: It's earned, but I think the biggest contribution from the sponsor is trust, to say, all right, you guys know the protocol, you know the responsibilities, we have to produce the IP, it has to be working. Right. But outside of that, we trust that CRO and site network or site to work together. And then what does it look like? It looks like conversations like this, but you know, not always through a podcast. Um, but it's the same conversation you and I have had 20 times, right? Which is why we're having it today here. It's saying honestly, hey, these are the things that work, these are the things that are not working, or, hey, we'll take this on, but we need to acknowledge that this is going to be a tough spot, right? The fact that I do swab one half hour, swab two, and then standard of care, we're going to enroll two people, and only because it's cold outside, you know. So I think those conversations that are realistic and work together, each one does their job, right? The CRO presses on the site but advocates for the site. Right. The site, you know, comes back and is truthful and honest about where they are and what's working and what's not. And I think that trust that filters down from the person who's paying the bills says, I've done my vetting, I've picked my right partners, and now go forth.

Emily: For a sponsor planning a respiratory program right now, with the next season closer than it feels, what's the one thing you'd tell them to do this month?

David: You gotta get your CRO picked, right? That should be the easy answer. The ink should be dry on that one. Depending on how directive the sponsor is around which sites to use, that CRO should be neck deep in picking the partners, not sites, partners who they are working with in the coming season. And then I would say, you know, it's all hands on deck. If that's not done already, you know, we don't know whether it's going to be late August, late September, late October, or 2028, the next time we see a decent COVID bump. If you want to be able to do this, you got to invest and trust that you're ready to go, right? Be fully prepared for when it does hit.

Emily: David, thank you so much for this. We definitely wanted to hear the respiratory season, respiratory study conversation, from the site's perspective. For listeners planning a respiratory program, David and the DCN Dx team have put together a respiratory planning timeline, a month by month look at what should be happening across the year, so the work is done before the season arrives. There's a link in the show notes. If you want to walk through your own program, you can reach us at DCNDx.com/contact. Thanks for joining us for this episode of Expert Insights.

David: Thanks for having me.