S4E20: Clinical Trial Trailblazing (ft. Brian Helfand, Endeavor Health)

Jordan Cooper   2:20
Got it. So let's go with a concrete use case, if you wouldn't mind. Walking us through. Now, I don't want to put you on the spot, so I'll give you a choice. Either patient Jayne has some kind of condition and the only treatment available for this maybe orphan disease is through a clinical trial being offered through Endeavor Health.That might be a good place to start. Or starting in the story of how Endeavor Health is leveraging clinical trials to improve access and maintain market share. Leave it in your hands.

Brian Helfand   2:54
Yeah, I think both, we can talk about both of those because I think they're both very relevant. You know, I do think, you know, we have 10,000 providers. Most of us are fellowship trained, really top of the game, have believed that the best care is constantly evolving.And as you start really pushing that envelope, you know, you move quickly into that clinical trial space, because that's really going to test and offer the latest cares. Sometimes, as you brought up, as compassionate care in certain oncology cases, which I'll give you an example of,to give access to treatments that, you know, patients would not otherwise have access to. And so, you know, even in a real world example, and certainly trials that I have either witnessed or have been part of, cancer trials are the lowest hanging fruit there because they're the most common.common because of that space is always pushing to hopefully stomp out cancer one day. But also, whether I'm talking about cancer trials or I'm talking about other even benign conditions,ranging from psychiatry to ophthalmology to urology. There are so many clinical trials in that space. But if you're going to use a concrete example, and specifically, you know, you have a patient, he's a 74 year old gentleman,who has a advanced prostate cancer. And, you know, he has gone through for many, many years a lot of the traditional therapies that have involved testosterone, wiping agents out. And once you go through so many differentyou know, treatments, you kind of come to an end. There's not a lot of new things that you can offer. And as an example, he was offered a clinical trial to look at several different things. Number one, he was able to get the most advanced imaging. So that is on trial to say, hey,

Jordan Cooper   4:57
Mhm.

Brian Helfand   5:12
we can locate that tumor with the latest, greatest, you know, kind of radio tracers in that field and really localize that cancer. And because it's a new radiotherapy or imaging technology, you can really leverage that to really localize that where the disease is and hopefully come up with treatments based on that.And then he was so happy with that result. And based on that radio tracer, he was actually able to enroll in a different trial that tagged a radiation therapy to that imaging agent. So that would target and localize that treatment that much better. And so that's the kind of thing that we're reallyaiming for is to say that, hey, these are not standard of care, but all of the trials that we enroll patients in have that ability to offer benefits to that patient, even though that they're not widely used or certainly in guidelines at that point.But it, but it improves the.patient care and access, and certainly the quality of care that patients get.

Jordan Cooper   6:27
So other than joining podcasts like this one, you mentioned that clinical trial of the kind you just described help increase patient enrollment. How is Endeavor leveraging its abilities to identify the appropriate clinical trials forfor eligible populations in order to increase patient enrollment and general market share. Of course, I guess the market share would be primarily for the target sick populations, but if there's any kind of tertiary benefits to well populations, that might also be worth mentioning.

Brian Helfand   7:05
Yeah, so I mean, I, we...Endeavor Health has changed names throughout time, but historically was Evanston Healthcare, a much smaller operation back over 20 years ago. But it was one of the first systems to employ an electronic health record system or EHR system. In fact,

Jordan Cooper   7:22
Mhm.

Brian Helfand   7:30
We were the beta testing site for the most common thing known as Epic. And so Epic has evolved and certainly we have data on, you know, millions of patients for over 20 years. And as that has evolved, we have been forward thinking to say, hey, we want to be able to overlay different electronic

Jordan Cooper   7:44
Mm.

Brian Helfand   7:54
programs so that we can quickly search patients for eligibility in clinical trials and to enhance and identify those patients who would qualify. So we have that ability to look at one of the largesthealthcare systems in the country and really quickly identify patients. And that's pertinent because a lot of trials can benefit the masses, but there are certain trials that are really designed for rare conditions.And so one of those issues has been that we haven't been able to identify those patients historically, but with these type of technologies, we're identifying those patients with the rare conditions and getting them in trials or offering them.

Jordan Cooper   8:32
Mm.Just to jump in for one second, Brian, because I want to clarify so our listeners understand. You're saying that maybe there's only 50,000 Americans with condition Y, and maybe they're not all in Chicago, maybe some are in Texas or Maine or Florida, and it just so happens that the biotherapeuticintervention that would treat condition Y is being offered through Endeavor and nowhere else, how do you find these patients that are not Endeavor patients but are across the country and bring them in to enroll them? Because in order to get approval by the FDA, you need a certainkind of amount of participation and you're needing to identify these patients. Is that what you're talking about?

Brian Helfand   9:31
Yeah, I mean, it goes both ways. It goes locally, right? Because we have 4.1 million patients to now in our data set to query on an annual basis and look for people who would qualify for, you know, rare conditions and common conditions. But we also have partnered through many different organizations, networks,but they're all electronically linked to a help identify patients, you know, kind of quicker. And a lot of this is really when you start looking.Um...in this type of space is in the oncology realm, the neuroscience realm, where a lot of the conditions and treatments may be more rare. So it again, has the ability to look nationwide to look for eligible patients. But you know, a lot of this is also posted

Jordan Cooper   10:16
Mhm.

Brian Helfand   10:22
on trial sites and government sites to make people aware and practitioners aware. But really, especially internally, when certain conditions are being met, there will be flags that pop up that can help identify those patients and make them

Jordan Cooper   10:35
Mhm.

Brian Helfand   10:41
provider, the current person who's taking care of that patient aware, so that they can, you know, refer to that trial or at least get that patient more information.

Jordan Cooper   10:46
Mmh.So obviously, Epic Care Everywhere is one way to try to access different instances of Epic across the country. Does Endeavor leverage connectivity to national networks in order to try to identify patients with certain diagnoses codes that might be eligible for this sort of trial?

Brian Helfand   11:14
A lot is in motion. So nationally becomes a little bit more of a problem, if you will, just because of HIPAA and things like that. But really through the connectivity, whether that's through Epic, whether that's through, you know, kind of organizations, whether that'sthe American Cancer Society, the NIH, all of that, we are part of all of those, you know, kind of trials. And certainly the awareness of that is made possible through that. You know, I think we have a much higher success rate because when you control the dialogue in the system,

Jordan Cooper   11:47
Mmh.Mhm.

Brian Helfand   11:55
It makes people more aware. And so while nationally, there's a huge presence, and certainly we have patients coming in all the time from other parts of the country for clinical trials, certainly the identification, if just being frank, is currently still emphasized within our own expanded network throughout the Chicagoland area.

Jordan Cooper   12:18
So, it's my understanding, Brian, that in 2025, Endeavor Health had 550 active trials across multiple specialties and 2300 clinical trial patients that were enrolled in those trials last year. Given the complexity and the vast volume ofpatients and trials and details, I imagine that there's a lot of data to orchestrate. Are there any data challenges? I'm asking this, of course, because this is Healthy Data podcast. Are there any data challenges associated with managing such a vast array of differing data sources andProblems you're trying to address.

Brian Helfand   13:01
Yeah, so, you know, the amount of data, these are big data, you know, issues. And that's awesome because what you're really reflecting on is that we have the ability, whether we're talking about genetic data, whether we're talking about large population data, and all of the imaging and all the lab work and all the patient demographics that go into that,This is big data there. For every patient in a trial, we estimate that there's over a million data points that we are constantly collecting. And that may even be a small, you know, data, you know, clinical trial. So, you know, that requires a lot ofbackup of data, and that requires a lot of secure servers, especially in today's era, where we're always concerned about information and protection at all points. And so we have, you know, certainly huge servers that are all, you know, kind of constantly monitored. And IDon't know the details of it, because I joke that our system is very much like Fort Knox. It's very hard to, you know, kind of compromise that system. But certainly all of the necessary systems are in place, the clouds, to really gather that.

Jordan Cooper   14:23
Mhm.

Brian Helfand   14:25
Data.

Jordan Cooper   14:26
Right. You know, it's another topic, and I guess leveraging the last few minutes of this podcast, I know that one of your goals is to increase access to clinical trials outside of major cities. So outside of Chicago, you're trying to look to get a larger catchment area. You're looking to reduce barriers to care withtransportation or hotels or food and expand the footprint of Endeavor beyond the immediate Chicago area. Can you elaborate on what you're trying to do and how data may, kind of what new data sources or what new data challenges arerelated to those initiatives.

Brian Helfand   15:10
So in a classic model, and something that we initially had to overcome, is that if you have a clinical trial, you have that patient come into your clinic, they often have to come in multiple times throughout the study. You have to have labs drawn, evaluated, et cetera.And so that for a lot of patients was a barrier because that just travel time alone, people didn't want to, you know, sign up for trials because it was considered a burden. And so, you know, certainly locally into the 4.1 million lives that we serve, that we've overcome that because we have so many different

Jordan Cooper   15:46
Okay.

Brian Helfand   15:50
you know, locations throughout a large system where patients can enroll. So even if you live in X part of Chicago, there's likely a clinical trial center part of Endeavor Health that, you know, you can go to to get your labs or to get you be seen evaluated, et cetera. And certainly,

Jordan Cooper   16:01
Mm.And.

Brian Helfand   16:09
Most of the trials will be offered, you know, throughout, you know, the entire system. So again, that improves access just based on location, et cetera. But then we're also forward thinking. And as you said, is that our goal is that it's not only just serving the lives that we see immediately in the Chicagoland area, but it's how do we serve a greater good throughout the

Jordan Cooper   16:19
Yeah.

Brian Helfand   16:31
the country as well. And so if patients are, you know, identified and you're on the East Coast, so in Maryland or in New York, and they want to be part of a trial here, is that possible? And the answer is yes, because in the era of telemedicine, in the era of so much virtual healthcare,that a lot of things that we can do can be done as certainly as a follow-up or, you know, at great distances away. Now, the exception for that would be if you're getting a drug delivered or something that actually requires multiple interventions and stuff like that.A lot of times, you have to come in town for that, and there's no way to overcome that part. But certainly, if it's a national trial, we'll help identify a center that may be, you know, closer that can give you that in that setting, trial center.

Jordan Cooper   17:20
Mmh.So if you were in a patient in New York and you were identified and needed to participate in an Endeavor trial in Chicago, would it be possible for that patient in New York to have labs or imaging done remotely and then have those samples shippedto Chicago.

Brian Helfand   17:53
So it's not a uniform yes, because certain clinical trials depends on the sponsor or the type of trial you're doing, may not permit it. But for the most part, that scenario that you described is very possible and frequently done at Endeavor Health.

Jordan Cooper   18:01
Mhm.

Brian Helfand   18:12
So again, our goal is to provide that care no matter where you are and that top quality. So if it's easier and you so happen to be in New York, you can certainly get local imaging, local labs done, send over that and overcome that for most trials. And again, some of this is just dependent on that.

Jordan Cooper   18:16
Mhm.Tong.How much of an outlier is Endeavor compared to other health systems across the country is becoming a, it sounds like Endeavor is positioning itself to at least try to become a national destination center for clinical trial excellence. Is this kind of common or uncommon as you try to gain market sharefar beyond the immediate kind of geographic area of your health system.

Brian Helfand   18:58
So, I think it is an uncommon goal. I mean, I think a lot of places in the country, you know, are really just...They're not as interested in, you know, providing cutting edge care. They're kind of happy with the standard and they will adopt practices as they become more routine. I think our positioning is we really want to offer really the cutting edge, outstanding, you know, care on top of the, you know, on top of the great care that people alreadyreceive here. And so I think that as a primary motivation, it distinguishes us. I think our nimbleness, and one of the things I didn't really talk about was, you know, what things are we doing to facilitate the process? One of the things that we do

Jordan Cooper   19:50
Mhm.

Brian Helfand   19:52
in research, no matter where you are, is we kind of hurt ourselves because you want a trial. Let's say I'm at, you know, the classic academic center. It usually takes over a year to get a clinical trial approved at your institution. And that's, you know, through the institutional review board, the study reviews.before that's actually up and going. And by that time, a lot of people have already passed you up. And a lot of times you've already missed a lot of patients that could have benefited from that. So as an example, our goal is that by the time you, a physician investigator says, hey, I want to start a study,We want to have that up and rolling within 30 days. It is, it's an aggressive goal. I think if we want to become really the leading trial and, you know, translational sciencedestination in the country. That's what we're going to really have to do to be looked at and viewed as a preferred partner.

Jordan Cooper   20:57
So, Brian, we are approaching the end of this podcast episode. I'd like to ask you a kind of broad concluding question. Endeavor wants to, you know, start a clinical trial and have it up and rolling within 30 days. You potentially have an entire nation full of possible future clinical trialparticipants who may be getting lab specimens or imaging drawn or done remotely across the United States from non-endeavor health providers. You're having lots of different data sources and a very ambitious timeline to reconcile all this dataFrom a data perspective, you know, what advice do you give to other health systems or perhaps to yourself a few years ago to overcome some of the technical challenges or technological challenges that are involved in getting to where Endeavor Health wants to be?

Brian Helfand   21:57
I think it's partnering with several things. I think that having an internal partnership with your IT department, right? All of this is going to be ultimately based on getting that data in an efficient manner. I think parallel processing. So we're so used togoing from A to B to C, but we want ABC to be happening all simultaneously, becoming efficient in how we look at trials and getting them up and rolling. The IRB should be working with the compliance, which should be working. So it all has to happen simultaneously.and most places are, you know, still sequential. I think when it comes to data, again, a lot of this is going to depend on the type of study, but as you're alluding to, we just have that complexity to get images in, et cetera. So establishing those secure sites to protect patient information,

Jordan Cooper   22:41
Mmh.

Brian Helfand   22:57
to get that information in a reliable way that you can trust and that can be then included in the studies is also important. And that sounds simple, right? I mean, these concepts are like, you got data, you want it, and we've got to bring that in. But there's a lot of workthat has to go on behind the scenes and foundation to make that happen. But again, because clinical trials, we don't want to increase risk to patient and we want to limit that risk as much as we possibly can. And so one of those risks cannot bethat we leak that information outside or that it was compromised in some fashion. So having those necessary guardrails in place is also.

Jordan Cooper   23:47
Brian, thank you so much for joining us today. I really appreciate your participation.

Brian Helfand   23:51
Thank you, thank you.

Jordan Cooper   23:52
And for our listeners, this has been Brian Helfand at Endeavor Health, the Associate Chief Scientific Officer.