The Rise of Rescue Sites: Clinical Trials in Times of Change
Attached to every clinical trial is a line of hope for a patient seeking a cure or better way to live with a rare, chronic, or limiting condition. Unfortunately, global events have disrupted the clinical trial landscape significantly in the past 2 years impacting the hope and lives of millions of people. Although rescue sites are most commonly thought of as an alternative to trials failing for more common reasons like lack of enrollment, Medical Affairs teams should be re-evaluating their overall strategy to make sure that even in the face of uncertainty, there is a path forward for clinical design. Rescue sites can provide that path forward.
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Garth Sundem 00:00
Welcome to this episode of the Medical Affairs Professional Society podcast series: “Elevate”. I’m your host, Garth Sundem, Communications Director at MAPS. And today we’re speaking about Clinical Trial Rescue Sites with Ariel Katz CEO of H1. This episode is sponsored by H1, whose platform helps life sciences companies, hospitals, academic medical centers and health systems, connect with providers find clinical research, locate industry experts, and benchmark their organizations. So area we have chatted before and I am excited to chat about rescue sites, which we have not chatted about before. And I was hoping maybe you could get us started. You know, it seems like with targeted treatments for smaller patient populations, everybody struggles, most people struggle with credit clinical trial enrollment. What is the traditional role of rescue sites?
Ariel Katz 00:59
Yeah. Good to be here, again, excited to be here. So the first question is, why are we talking about this with Medical Affairs? Right. And I’ll start with that, and I’ll get into the role of rescue sites. So what we’re seeing today most life science organization, pharma companies, biotechs, is Medical Affairs and MSLs are getting more and more involved in the selection of sites and principal investigators to run a clinical trial, not trauma. Phase four, I’m talking about like phase two phase three clinical operations team wants to find a site. And they’re starting to go and tap on the MSL shoulder for some companies that happen forever. For certain companies. It’s new. And what the way it’s being phrased and what I’m hearing is they’re marrying the qualitative with the quantitative. So the quad the quantitative is easy. CRO, who has statistics about where they were unsuccessful trials, you might look at some tools or databases and be like this is where patients are based off claims data. Qualitative is the good stuff. It’s the MSL, who literally was there last week talking to the nurse practitioner and the physician and said, the here’s the patients that are here, here’s where I’m struggling, here’s therapies that can be useful. Here’s the types of patients that I see. And you can’t get that from statistics. That’s a qualitative and so we’re seeing that marrying of qualitative, quantitative and qualitative, which is medical fire Medical Affairs in this context.
Garth Sundem 02:21
Oh, that’s interesting. I thought maybe we were going to be talking more about Medical Affairs running these clinical trials at rescue sites. And you’re saying that maybe in addition to that, we’re talking about Medical Affairs as an early collaborator in development?
Ariel Katz 02:33
Yes, yeah. Yeah. And we’re seeing more and more and more of that, specifically, MSL is basically stuck in the sites of trust, we run out. And being a really loud voice at the table, I spoke a lot about how Medical Affairs is no longer navigating the seat at the table ever knows the seat. And this is one of the contributions that we’re not at all companies. But the trend that we’re seeing is definitely them having a louder voice from happening at the top 10 pharma companies, and met with like three out of the top 10, last week, SVP of Medical Affairs who’s talking about these things, they’re talking about how their voice is getting more important in site selection and working with their clinical teams, and biotechs to like, earlier stage companies.
Garth Sundem 03:15
Okay, so site selection. And you know, usually you would like to find a site that Autumn automatically or immediately has high enrollment and strong clean data. And that doesn’t always happen. And when that doesn’t happen, where do we go from there?
Ariel Katz 03:34
So when we talk about a rescue site, that means you pick the site that didn’t work, you got to pick a new site so that you can get your enrollment numbers your trial complete, sometimes, like bring your therapy to market. What is the role in Medical Affairs and specifically MSLs. And doing so they know where the patients are? They are in the field every single day. They’re talking to investigators, potential investigators. The other key thing that it relates to the trend happening in Medical Affairs and the trends happening clinical operations. 10 years ago, Medical Affairs teams would talk to a key opinion leaders, academic medical centers, people, today, it’s changing. They’re talking to community leaders, regional leaders, like God, people in the community, people using treatment, all these different different types of thought leaders, different types of stakeholders that Medical Affairs have on the clinical side that used to run their clinical trial at MD Anderson. And all they want to do now is move to the community. Because the patient’s exists there and they don’t know how to tap them. Medical Affairs is going through that same transition and they know where those patients are, and they know who the physicians are, that can become investigators that have not been investigators. So we’re trying to spin up a new site and a rescue site in this context. The role of Medical Affairs is actually super important. And having that voice and saying, Here’s where the patient population is, here are the individuals to speak to. And so that’s the role that we’re seeing Medical Affairs start to play around rescue sites.
Garth Sundem 05:00
That’s interesting, it almost seems like Medical Affairs could help expand the clinical trial site offerings. You know, even outside the context of rescue sites, if we’re moving more to the community anyway, and the MSLs know the community. Are we only talking about rescue sites here? Or are we talking about the MSLs, bringing treatments, you know, clinical trial treatments where they’re needed?
Ariel Katz 05:23
It’s definitely the latter. And that’s the qualitative. It’s even it’s like, the blind versus the qualitative, a lot of teams, I’ve never ran trials in the community. And all they talk about is I need to call it by gum, native, not naive, naive sites. And so there’s a lot of naive sites, sites that have never ran a trial. But I’m the facility, the patients and they invest in the physician and the care team to be able to run a trial. And the Medical Affairs team is aware of those locations to be able to do that. And so rescue sites is like, I have to do it really quickly. Yeah. And I’m gonna go call my MSL and be like, where should I do it? And so it’s even more pertinent, where they could just make the phone call, instead of needing to depend on the CRO and get the survey and get the feasibility questionnaire and, and do all these things. They can just call up the Medical Affairs team who will answer the phone and they have the relationships and they know where those sites can be.
Garth Sundem 06:13
Or CROs catching up in terms of data at all, meaning that does it just happen that right now we’re a little behind in being able to capture community sites or naive sites with data, but the CROs are going to catch up? And this won’t be a role for Medical Affairs in the future? Or do you see this being a future role as well?
Ariel Katz 06:32
The CROs, they have no idea. Like I had dinner with
Garth Sundem 06:36
In the nicest way possible.
Ariel Katz 06:39
But they hear things they know they have no idea and they want to help. I didn’t mean that. That’s funny. No, they want to help. They want the data they want to know, like they want the input. They want their sponsors in this instance, to share what sites that they’re aware of. Larger sponsors have more resources and larger Medical Affairs teams and have more insights into this smaller companies don’t and they rely more on the CRO. But the ideal is a marry between what the sponsor does and what the CRO knows, because they will have they all have their unique experiences. CRO has experiences from working with other sponsors working on more sites experience and certain sites and how that’s worked. Their sponsor has a Medical Affairs team in the field every single day, they have their own data. And so the combination is what works best.
Garth Sundem 07:20
All right, well, let’s talk COVID for a sec, because clinical trials changed a little bit in the last couple of years. And you know what, like you said, we used to run all our trials at MD Anderson and the big cancer centers and where have you? What changes have you seen in terms of COVID for clinical trials? And I’m wondering if it’s just harder to run a trial these days?
Ariel Katz 07:44
Yeah. Yes. To the second. The impact has been amazingly large. From the delays that we’ve seen around clinical trials, patients are coming to participate. It’s been it’s staggering what those numbers look like. That’s one of the biggest changes the other biggest changes. The two years ago, no one was talking about decentralized trials. Now, the only thing you hear is decentralized trials and doing trials outside of the hospital setting during COVID. Patients were literally not going to hospital settings unless they had COVID. And so that you’ve seen accelerations and a pull forward of what the future looks like, which is like remote patient monitoring, decentralized clinical clinical trials. And the delays, it’s hard to see the delays impact immediately. But you’re gonna see the impact of trials will take longer, and the therapist will come to market as quick because of what COVID did. And
Garth Sundem 08:39
What I’m wondering is if they’re just more need for rescue, is there more need for rescue? Or some trials needing to I don’t know, pivot or adjust?
Ariel Katz 08:50
Depends where now it’s more like what did the war in Ukraine do around the rescue sites? And the answer is a lot of sites in Russia and Ukraine need. I feel like COVID is chapter two. And now we’re on chapter three of why clinical trials can be delayed in 2020. Yeah, so the first chapter was COVID second chapter would be geopolitical changes happening in Europe and Russia. And so, yeah, I think rescue is people are now going more and more to hospital setting, there’s less fear that I’m gonna get COVID If I go to hospital, but there were some disruptions to trials. That happened. It’s happening because of the Russia Ukraine conflict.
Garth Sundem 09:31
Well, it’s like Medical Affairs. You know, it’s almost like we’ve talked about MAPS recently. In terms of a personal competency. People are saying learning agility, learning, agility, learning agility, and it’s almost like Medical Affairs is the agility function for Pharma. Is it that because MSLs are in these communities, they can just help farmer pivot wherever it’s needed. And that might be rescue sites.
Ariel Katz 09:59
Yeah. But it’s like who before a drug launches has the relationship with a physician from afar representing a pharma company? Yeah. MSL to Medical Affairs and nobody else does. They’re like the umbilical cord to the community. And if you’re trying to find a site really quickly, I would definitely want to tap on that more than anything else. And we’re seeing that happen.
Garth Sundem 10:21
Well, so how do we capture this? We’ve talked about the context. Now let’s talk a little bit about the how to and you know, it seems like one mechanism is the CRO reaching out to metaphors and saying Help, where should I go? Is there also a role for insights here? Or how are you? How do you capture what MSL is know about, you know, community sites as a whole or other sites or non traditional sites or decentralized sites? How do you capture that?
Ariel Katz 10:48
So what we’re starting to say with, say, a couple dozen companies that we partner with is the partnership between their clinical team and their medical team becoming a lot tighter sharing of information, there’s no firewall, it’s not like commercial, thick firewall can’t trip over it. Clinical, you want handshakes, you want to hug. It’s a very different relationship. And so the sharing of information between those two teams, the sharing of databases, the sharing of who MSL is or engaging with? Well, you also see as like, a clinical team wants to tap on this potential investigator and they don’t realize MSL is talking to them on a Tuesday. And so the sharing literally happens where someone and Global’s meeting them at ASCO. And so the sharing of information between Medical Affairs organization and clinical operations, visibility teams is critical to enabling this and it will lead to more successful sites because the MSL and Medical Affairs team knows qualitative clinical team does not.
Garth Sundem 11:42
So it’s not only one hand knowing what the other one’s doing, but an actual handshake between the two, you know, and then are the MSLs. What I’m wondering is, I mean, how do you capture this? You talked about database sharing, we’re not just talking about, you know, your your, your, you know, your customer? Database, right, but but how do you, how do you capture this information,
Ariel Katz 12:06
I could just share from our personal experiences. We profile healthcare professionals, having a central source to be able to view that this healthcare professional is being engaged with an MSL is also working on these three different trials. And the clinical team is able to look in one place to know who medicals engaging with new clinical is trying to engage with, has really built that bridge that didn’t exist before medicals role in clinical development, or clinical operations was smaller, but it was still hard to exist. And now we’re seeing a lot of taps on the shoulder between colleagues, better collaboration, especially at these large, top 20 pharma companies where it’s like the right hand, probably not talking to a left hand most of the day.
Garth Sundem 12:50
All right, well, so we’re involving Medical Affairs earlier, we’re getting in with research and development. We’re looking to decentralize trials, some of which might be rescued due to the pandemic or geopolitical issues in Europe, and or other more targeted, it’s just harder to find patients. So it’ll be interesting to see how much clinical can lean on medical for this expertise in finding non-traditional trust that it’s going into the future. So, let’s leave it at that for today. Thanks, Ariel for joining us. To learn more about how your organization can partner with H1, visit H1.co. MAPS members don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series: “Elevate”.