De-Risking Clinical Trials with Flexible Site Models

Jimmy Bechtel talks with Darcy Forman, COO of Lightship, about how hybrid site models can reduce operational risk in clinical trials. They discuss matching visit types to the right setting (clinic, home, or mobile), lessons learned from the pandemic's rapid shift to decentralized trials, and how to maintain strong investigator oversight across different delivery models. Darcy shares practical insights on what it takes to implement flexible approaches successfully, including the importance of investigator buy-in, standardized processes, and building trust-based relationships between sites, sponsors, and CROs. 

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Jimmy Bechtel 0:01

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest trends, insights, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Chief Site Success Officer with SCRS. I'm joined today by Darcy Foreman, the Chief Operating Officer at Lightship, here to talk about how we de-risk clinical trials with expanded access models. Darcy, it's great to have you with us today, excited to talk about this topic that doesn't get enough attention, So if you wouldn't mind first though, we'd love to learn a little bit more about you and Lightship.

Darcy Forman 0:36

Awesome. Thanks Jimmy. Thanks for having me today. as you mentioned, I'm the Chief Operating Officer at Lightship. I've been here about nine months, but I've been in the industry, upwards to 30 years. spent my time, started at Pfizer, spent time in in CROs, but about 10 years ago is when I really. fell in love with this idea of clinical trials being done a different way. I spent time at Firma, which was my first foray and understanding that we could deliver clinical trial visits in patient's home. After my stint at Firma, I was at Science 37, where I was a chief delivery officer there for four and a half years, and that really kind of opened the aperture in my eyes in regards to expanding access and providing. Enrollment and clinical trial opportunities to patients that are typically forgotten about and not necessarily given opportunities. After my time at Science 37, I took a little bit of a break, which, as a side note, I highly recommend for anybody that has the ability to kind of decompress and revisit what, what you're doing in your life. But I knew I wasn't done with my mission. And so again, very fortunate to be here at Lightship where, you know. Really focused on expanding access, through this organization. And we're doing it in a slightly different way, but I hope, and I truly believe that it is a fundamental way in which we can solve problems for sponsors, CROs, but more importantly patients, in regards to being able to participate in trials in a less burdensome way. So thank you for having me, and I'm excited to dive into this topic with you.

Jimmy Bechtel 2:11

I again, am as well. And the topic is such an important one. again, that doesn't necessarily get enough attention, but I wanna start us off, Darcy, talking about that expanded access site model and what might distinguish it from a more traditional approach, and how does matching visit type to the setting in which that budget occurs, help reduce some of that operational risk.

Darcy Forman 2:38

Excellent. So yes, at Lightship we are a site organization. We have brick and mortar sites in our network. But what it distinguishes us is that we also have investigators, that can deliver trials through telemedicine. We also have 50 state licensure with our mobile research team. So by combining all of those elements, we're able to match. Visit type, not just studies, but actual visits with the best approach. That's gonna, work for the study itself, the protocol, the assessments within that study visit, as well as patient burden, et cetera. So kind of to double click on that. If you envision a study, the patient can choose if they want to do it in the clinic. 'cause we know some people want to come in and see a doctor in a clinic. But if it gets to be too much to participate, that patient can stay home. We can. Follow that patient on a vacation and be able to service visits, while they're outta town. but also, from an innovation perspective, we know that not everything can be done in the home. That's a big lesson that we've learned. And so we are meeting sponsors and protocol assessments on the innovation curve where they are. So it really kind of takes no off the table, we can match. The visits based on the quality and the efficacy and the places that it needs to be done. But if the study allows, we can allow patients to stay at home and, do things on the weekends and after hours, et cetera, so that we can increase that participation.

Jimmy Bechtel 4:14

That's great, Darcy, and it's really exciting to hear about all these novel approaches to clinical trials and that combo approach, I think is a really valuable opportunity because it's within the same. System. Right? The same ecosystem, the same environment potentially. But it also, like you said, is built on the enablement for what's best for the patient. And if it's in person, great. If it's, virtual or in their home also. Awesome. But that, I think allowing that choice and that ability is, like you said, it really goes to how we. Set up the patient for success, but also de-risk the operational execution of that clinical trial.

Darcy Forman 4:55

Yes.

Jimmy Bechtel 4:56

And I know the pandemic really pushed this decentralized method really quickly into, this model of, either partial hybrid approaches, so what lessons from that period. Should shape a more measured and flexible approach today. what kinds of things did we learn being a company that has enabled this as part of its core offering, that we should continue to bring forward?

Darcy Forman 5:23

Yeah, there's so many, we could probably spend the entire podcast talking about lessons learned from the pandemic. but it really comes down to it doesn't have to be all or nothing. So, from that lessons perspective, we know that investigators don't necessarily want to delegate and or let go of. Oversight, not that, they can't of activities in the home by using nurses that they don't know. And we also know that not every assessment can be done in the home, et cetera. So again, at Lightship it's really about kind of de-risking and. Picking the fit that makes sense. Without pushing everything to feel like it's innovative or scary. Because as the pandemic, came to an end, the world started to revert back to the old ways and realized that some of the stuff that we had to do during the pandemic, it's the stuff that we did and we definitely pushed. Pushed things forward, but there are still question marks on is it the right way? Is it showing? Equivalency by doing something in the home versus in the clinic. And, so again, at Lightship we're not saying we don't wanna be innovative. We do. If we can think of a way to do it, to make something easy, we're gonna push ourselves on it. But it doesn't always have to be innovative. We're gonna focus on the highest level of quality because that's, at the end of the day, what matters. We're gonna focus on patient-centric approaches so that we can increase our enrollment potential in particular studies, but we're not gonna necessarily always have to push to do something that. Maybe makes somebody uncomfortable or maybe makes the regulators a little uncomfortable and not ready for. But at the end of the day, patient care cannot be completely. Disengaged from human interaction and all of those things. And there's, again, as I've mentioned, there's assessments that are always going to have to be done in the home. And so by having this three pillar approach of brick and mortar, fully virtual, and then those hybrid at home visits, I think really kind of. Again, takes no off the table for sponsors and patients to be able to participate in trials, but not always feel like we're doing something that people aren't ready for or that is making them uneasy.

Jimmy Bechtel 7:55

Thanks, Darcy. It's such an interesting, perspective because we approach new and innovation and whatever term you want to use, approaches on clinical trials in a lot of different ways. you know, sometimes We start with the patient or we start with the site and we work backwards from there. But other times, I think kind of alluding to the point you're making, which is not the right way and not the way that you're iterating. We start with the dollar and we work back from there like, what's gonna be the cheapest or most cost effective way. And we don't always take into consideration the site and the patient, but it's great to hear that, you know. Light shift's focus and the work that you all do starts with, what is gonna work for the patient and let's make that as efficient and effective as possible to meet their needs instead of working with something that we deem quote unquote efficient or effective. Because we were able to. Demonstrate obvious cost savings or dollar reduction or whatever. But that all becomes very theoretical until we apply that to the site of the patient. we don't really know how that's gonna work in a real world application. So then we have to go backwards. The sites get mad, the patients get frustrated, they drop out. So starting, like you said, focusing on what's best for the patient and for the situation for them, and working back from there to make that process as. efficient and effective as possible is, a really valuable approach.

Darcy Forman 9:21

Yeah, no, absolutely. We hear it time and time again, right. Patients, participants, they. There, there's a trust issue, Right. And they don't want to be Guinea pigs. They want to, participate. They want the opportunity to understand and to advance and potentially have clinical trial as a care option. There's so many reasons why people want to participate in trials, but there's this huge hurdle of. Feeling disintegrated, right? Like that they're not truly a part or they're not a part of the journey and they don't understand and they're just, I hate to say the word Guinea pig, but there's still this element there patient journey. Patient satisfaction. Patient awareness and kind of how. To bring the clinical trial into their normal life where they feel a part of it, and easier to participate is a hundred percent what we're always trying to do.

Jimmy Bechtel 10:15

It's a great point, and I do want to take it kind of back to the site portion of things. So talk to me, Darcy, this is the kind of a question that we always know is a little awkward and no one really knows the right answer from the site perspective, but how do these integrated teams and these mobile research units. All the elements that go into this concept of decentralization in whatever capacity. How do you maintain that strong investigator oversight when we're operating and executing across these different settings?

Darcy Forman 10:46

Yeah. No, it's so important and I mean, I will tell you at Lightship we are. We are gonna be really transparent, right? We have eight sites in our network. It's not a massive amount of sites. we have the 50 state licensure for investigators and our nursing team. But you know, we're not the biggest organization out there. But what matters to us and the reason why we are disciplined in the size that we are and what we say we can accomplish is because it comes down to the three things in which you're talking about in regards to that investigator piece. It is investigator engagement. Meaning that all of the investigators that we have at our brick and mortar locations, as well as through our virtual network, a hundred percent believe in the mission and the vision that we have in regards to delivering trials, right? They are bought into the ability to do things through telemedicine. To delegate to mobile nurses and that they know that everything is done with the utmost quality and safety and that patient kind of. Peace in mind. So number one is investigator engagement. They're bought in. Second is process. So again, all of those sites and all of our staff, both like the CRCs, our mobile nurses and that site staff, same SOPs, same working procedures, a visit done in the clinic, a visit done in the home is gonna feel the same. It's gonna be conducted the same. It's just the different location that it's done. And all of the processes are the same across all of the three places that we deliver trials. And then the third piece that strings it all together is technology, right? So again, visits in the home, visits in the clinic, centralized technology with our eSource, our e-consent doesn't, it has the same feel, the same ability for the investigator to know what's happening when a visit. Is happening in the clinic or if the nurse is in the home and there's just a connectivity through that whole thing. But it comes into, and again, the one that I said first is engagement and buy-in. And if you don't have the investigators believing that the model is the right way to deliver trials, it just doesn't. It's not gonna work. we're pretty disciplined. We're pretty picky about who's in our network and how we do things because at the end of the day, that matters the most in regards to making it successful.

Jimmy Bechtel 13:13

Thanks, Darcy. it's interesting and I think that's a really critical piece of it from what I heard, this concept of holistic, cultural onboarding of these investigators to bring them into. An environment where they know that is built upon this concept of de-risking and, management of all the different aspects. So I think it's unique to the work that you do in that you run the end-to-end operations of it in most, if not all cases, or you're going to assure that anything that might be third party is going to be appropriately vetted. Right. you talked about the quality that you all bring in there. Maintaining that I think is really an interesting piece. An important piece that we don't always see outside of that, right? A traditional site model might have an investigator who's, going down this path of decentralization and we get a third party. to help come in and execute, said service for the clinical trial again, where the investigator's oversight can sometimes be a question mark. So, thanks for sharing, because it's your environment and because, you kind of run the end to end of that You've built systems and processes. Around this model, it allows you guys to be a little bit more nimble and effective, in assuring the oversight that a lot of investigators are worried about in traditional models.

Darcy Forman 14:32

Absolutely, yeah. I mean, again, I think just to be very. Clear. it is all of us, right? Like it is the Lightship team that is delivering our trials as a site in all of the approaches that we take. So same processes where the delegation of certain visit or a certain activity is happening to a LIGHTSHIP nurse or coordinator from an LIGHTSHIP investigator. So again, it's it, we've taken that one piece of, do we. Do we, I hate to say, do we trust, do we believe that a third party vendor is doing the right thing? We took that kind of ambiguity off the table. There's a lot of great things happening with third party vendors. we took it all in-house, right? So we took that question mark off the table, and it gives us a hundred percent buy-in on the execution model.

Jimmy Bechtel 15:22

It's really an interesting and I think, effective approach to that. I wanna round us out, Darcy, with our final question here, but I want to make sure we touch on, sponsors and CROs. So drawing from your experience then, and when the work that you're doing, what steps can our sponsors, and potentially our sites, take to. Collaborate effectively when adopting these flexible and hybrid models. How can we make sure that when we're embarking down these paths, in this relationship dynamic with our sponsors and CROs and our sites, and make sure that these are implemented in a way that's going to produce success?

Darcy Forman 15:58

Yeah, I think this is the one that's still the long pole in the tent, but it really I mean, it seems so simple, but it comes down to collaboration. You know, we are very transparent in regards to saying what we've done, what we can envision doing. Like I said, We're not gonna recreate the wheel on every single study 'cause that just, doesn't feel good to anybody. But we will be innovative and talk through, like, Hey, we can see a path where we can do X, Y, and Z to deliver this study in the home or on a mobile research unit, et cetera. But it's gonna require us to do this, right? Like we, we can provide those kind of scenarios. But it comes back to sponsors being willing to say what makes them uncomfortable, and us having very open conversations of, okay, this is how we've done it in the past. This is the success that we've had. This is where, you know, oh, we haven't done this in the past. Can we partner to try? And if it doesn't work, we go a different direction. And so it's just kind of providing a safe space. Right. And I think, I've been in this industry a really long time. You have, we have some sponsors that are so collaborative, so willing to provide that safe space where we can talk about what we do, know what we don't know, be really honest with each other. And when that happens. Like the magic happens, right? Like there's just trust. It's a shared goal. It's an ability to talk about what's going right, what's going wrong without the fear of, a tongue lashing. And then you have the other side of it, where there's still this very sponsor vendor relationship going on It really detracts from the ability to move the needle on innovation and move the needle on really solving the problems of clinical trials when there's just this kind of fear or uneasiness of the conversation always being somewhat tense and not. Necessarily being in a place where we can just be honest and work together to work through the stuff that doesn't go right, because I can't even count how many trials I've been a part of. It's been a lot and there's never been a perfect trial. And I would argue to anybody out there that there's never a trial that doesn't have something. Happen where we're stubbing our toe and we gotta fix it. and again, we try to de-risk and everybody tries to de-risk everything that you can, but there's always gonna be something. And so being able to have that kind of safe environment where, you know, this is what happened, this is what we did about it, this is how we're preventing it from happening again. But by doing this, we are able to allow patients that normally don't participate in trials. An ability to be in a trial, I think at the end of the day, that's worth it. So it's getting to kind of a relationship. it comes down to relationships and trust between the sites, ourselves as the sites and the delivery of the trials with the sponsors and the CROs.

Jimmy Bechtel 18:57

Well, Darcy, I think that's a really excellent sentiment for us to end our conversation on because I couldn't agree more. What, what's really important in the execution of clinical trials, we've come to learn, through conversations and data and, and what have you. One of the lessons, big lessons is that you hit right on the head. Every single clinical trial is going to have, its challenges. Nothing is going to go perfect 100% of the time. And what really matters is the quality of the sites that you choose. And their ability to execute on that clinical trial and maintain an effective relationship with the patients, which I would argue is kind of a no brainer for them. they do this really, really well. That's what they're in it for. Where we do start to see the struggle then is how we. Manage those challenges, trials, tribulations at the sponsor, CRO and site level. thank you for highlighting that, building that baseline level of trust and ability to communicate effectively. In that relationship is going to allow us to nimbly act in the event of some sort of challenge, and it's about how we identify, address, and move past those challenges that really make the difference in the end for not only the trial, but also for the patients that ultimately there to serve. So thank you for your time today. And, for being here with us and, sharing a little bit more about the work that you do and some great insights into the work Lightship does.

Darcy Forman 20:23

Thank you so much, Jimmy. You know, we're proud impact partners for the SCRS, and we love the mission that you guys are doing to continue to elevate the site's voice. And, you know, lightship being a site itself with the network and the way that we deliver trials, we consider ourselves a site. So we're proud to be a part of SCRS and thank you for having me today.

Jimmy Bechtel 20:45

Thank you for being here, Darcy, and thank you to Lightship for your partnership, and I hope that everyone listening checks out our other site focused resources made available to our entire community on our website, my scrs.org. Including other podcasts, webcasts and opportunities become evolved with partners like Lightship in the future. Thanks for tuning in and until next time.