Unifying Research S2E3 - Research Administration and Participant Caregiver

In the latest episode, I speak with a research expert on the administrative side of running a program at a Cancer Clinical Trials Office. I also speak with a caregiver of someone in a research study.

My research expert guest is Michelle Marcum, the Senior Director of Clinical Trials at the University of Cincinnati Cancer Center. Michelle discusses what it looks like to run a clinical trials program in an academic medical center and cancer center. She also shares how her program is managed through the lens of a mission-driven patient-first model.

My patient guest this episode is unique. I speak with Brian Blackmon, a caregiver for a research participant. Better understanding the role of a caregiver in a research participant's experience is so important, yet there aren't many of these conversations taking place. Brian does a great job of explaining the challenges and opportunities for improvement for this vital role.

Additional resources:

• Connect with Michelle Marcum on LinkedIn
• Connect with Brian Blackmon on LinkedIn
• Learn more about the University of Cincinnati Cancer Center Clinical Trials
• The Caregiver Action - a resource for caregivers of research participants
• Connect with Univo to learn more about our mission and services
   
   
• Learn more about Univo's partners working together to bring the patient's voice to research:
• Clinical Trials For All
• Savvy Cooperative
• Inspire
• Children's Flight of Hope
• The Patient View
• AAHRPP

Transcript

Intro

SPEAKER_01 0:07

Hello and welcome to the second season of Unifying Research, a podcast about bridging the gap between the business side and patient side of the research industry. I'm your host, Justin Osborne. I have the privilege of working with an amazing group of people at Univo IRB, the fastest growing IRB in the industry. At Univo, we believe patients should have a bigger voice so clinical trials are better and more accessible for all. So we're using our network and platform to not only give patients a voice, but also share industry expertise for those of us working to improve research from the inside. Each episode will have two conversations, one with a research professional discussing their area of expertise, and the other conversation on the patient side and experience with research. My hope is that these episodes will spark further conversations, creating opportunities to bridge the gap between patients and research. Quick disclaimer before we dive in: the opinions you hear on this podcast are our own and don't reflect those of our employers, past or present. We could be talking about research, data, regulations, or even laws that affect your organization, but this is not legal advice. My first guest on the research expert side is Michelle Markham. Michelle is currently the Senior Director of Clinical Research at the University of Cincinnati Cancer Center. With over two decades of experience across major academic medical centers, including Mayo Clinic and University of Kentucky, Michelle specializes in clinical research operations, quality oversight, building successful programs, and workforce development. I spoke with Michelle about her role on the administrative side of running a cancer clinical trials program. We talk about the infrastructure needed to support cancer clinical trials and how that infrastructure is guided by the larger, mission-led focus of ensuring more access to trials for patients in their community. It's a fascinating discussion that dives into the quote business side of research, but it's also refreshing to hear Michelle frame her work through the lens of the patient in their experience. It's always fun talking with good leaders, and I hope you enjoyed this conversation as much as I did. So without further ado, here's my discussion with Michelle. I am very excited to have Michelle Markham with me here on the podcast. Michelle, thanks for hopping on.

SPEAKER_00 2:22

Thank you. Happy to join.

SPEAKER_01 2:24

So, Michelle, before we jump into our topic, can you give us uh a background about yourself, how you got into research in the first place, and and uh what you're doing now?

SPEAKER_00 2:34

True. I think, and you may hear this on uh your podcast quite often, but I think like many others, I sort of fell into the idea of clinical research as a career.

SPEAKER_03 2:45

Yes.

SPEAKER_00 2:45

Uh I was enlightened by the potential of it. Whenever I was a senior in my undergrad, I took a research applications course and really enjoyed the class and just the idea of conducting research. It was and it was focused on clinical research and the applications of it. And my professor happened to be someone who had a health and developmental genetics lab. And because the course was interesting to me, I ended up asking him if I could do a work study for a semester in his lab. So I did that and got to, you know, just kind of experience being part of some projects. And then after I graduated, well, well, let me back up a step. I actually changed my major then related to that. It was initially a nursing major when I was in college, and then loved the idea of working in the medical field, but I also really like science. And so I think the piece of the work that was missing a little bit for me from a nursing aspect, I suddenly realized was possible in work when it came to working with research that touched humans and and and our healthcare and and things that we face all the time. So I think that you know that it was really a kind of a pivotal moment for me personally. So after I graduated, I ended up working for that professor. It was just a part-time job, but I stayed there for maybe six or eight months, just again, getting some more experience. And then ultimately I ended up uh starting to look for positions in clinical research. And I ended up becoming a clinical research coordinator. My first role was at Neo Clinic, and I and my first role was in oncology uh clinical research. And that was um, I don't know if I want to use the years here.

SPEAKER_01 4:52

You don't have to.

SPEAKER_00 4:53

Okay. So so after that, so I spent several years working on oncology clinical trials as a coordinator. Uh ultimately ended up specializing just a little bit. I transitioned to more of a program manager type of role. Uh, I started working for one PI who was a cancer epidemiologist. And so he hired me specifically to work with his program. Again, I was still within Mayo there. And then that sort of snowballed work. So essentially, I was a coordinator at Mayo for a total of we can code the years here, 2004, eight years, uh, kind of taking on additional responsibilities in that coordinator role during that time. So kind of moving from just managing the projects to more of understanding some of the contracting aspects. And at the time when I was a coordinator, I also did the regulatory work, budget development. Move on to I was very fortunate to work with PIs who gave me opportunity to participate in publications and meeting presentations and things like that. And after that, I moved into a supervisory role at Mayo. So that kind of started my stint in uh management. And so I managed there for a few years before, again, in the Cancer Clinical Trials office, but I actually had a dual manager role with other coordinators working on more population-based projects like I was. Um, so more translational registry-focused work. And then ultimately I ended up, for personal reasons, relocating to Kentucky and working there for Markey Cancer Center and their quality assurance office. There, I first was in monitoring and auditing, and then in education, those things kind of naturally fit together, of course. Not only the materials for onboarding of new staff, but things you identify for continuing education opportunities. You might see those, you know, when you're monitoring and auditing. So was all part of their quality assurance program. Uh, until finally I came to my role here with University of Cincinnati Cancer Center and uh as the director. And so now I have a role in overseeing really all the the operations of our office, including those quality assurance components and things like that. So it's been really great to have sort of all the background experience and understand a little bit about the roles of the people that I work with on our team every day.

SPEAKER_01 7:37

So yeah. No, that's awesome. Thank you. Thank you for sharing. So, and I I want to just to lay it out for everybody listening, I I want to talk to you about your role specifically as the the director there in the cancer center at UC. I mean, you have sort of the the administrative leadership job running this sort of program there. I want to talk about what that looks like, not just at a uh an independent site, but you are at an academic medical center at a cancer center, right? So I know this is is very sort of uh niche, but you know, obviously there's a lot that goes into the administrative side of research that if you're just not in that world, you just don't have any visibility into it. I I guess I'm curious, hearing how you got into this and started out as a coordinator, did you always have the sort of interest of going into management slash leadership business stuff? Or was it what did that just happen because the opportunities came up?

SPEAKER_00 8:34

I really didn't. I think it happened because the when the opportunities came up. I I would I will say this in in my roles as a coordinator, as they progressed over time, I was often involved in sort of building maybe the infrastructure to execute a larger research study, for example. Okay, or the components that were really going to sort of set this project up for success. And so then I think one of the things that I recognize is that I like being part of building. And, you know, what I really have found rewarding about working in research throughout my career is really that I'm contributing to improving the care of people, right? There is something that about the work that I view it as more an act of service, right? I want to help others. And so I think even though my my role now is a step removed from interacting with our research participants or patients in the healthcare setting every day, I know that if I can build the right framework to successfully and conduct quality research, then I still feel that I have this contribution overall to the next generation.

SPEAKER_01 10:02

Absolutely. I love that. I love that. No, I think I think you you obviously do that as the the job, it sounds like, right? Is to build and and maintain or whatever that that sort of infrastructure, like you said, so that these studies can run there successfully, patients can enroll in them. Like that's that's awesome that you're that A, that you recognize that it is sort of a step removed, but also that you understand the the connecting points, right? Like how your work and that I again, research is so siloed, even within an organization, but especially when you look back at like what uh a pharmaceutical company, a sponsor does versus a CRO versus a site, like everyone does their own thing and they don't really have a lot of visibility into each other's worlds, so yeah, understanding how you connect to the the actual purpose, because honestly, that's why everybody should be doing this in research, right? Like you you have to figure out how you connect back to the patient because you know, I guess why else would you be in this industry? Um but I I do want to so you mentioned the the sort of infrastructure framework. Can you help us understand what that looks like? If you could sort of bucket out, I'm just saying, I'm thinking about a cancer center, right, that does research. There, there's a lot going on. In your role, what does that framework look like? What are the functions? What are the either the operational functions or the the uh tasks that you know people that you're in charge of? Like how does that break down?

SPEAKER_00 11:31

Well, I can just kind of talk through a little bit of about our office structure. I think in a lot of ways we look similar to other cancer clinical trials office, but um, so just touching on some of the elements that fall within our team. We do have, of course, all of the regulatory components. But for for us, I have distinct, I have a distinct team that focuses on uh not only the regulatory pieces of trial activation, but then the regulatory aspects of regular maintenance. So once a study is open to accrual through the time of closure, we have what I would call our clinical research coordinator teams. They're made up of our staff that are interacting with the potential research participants and research participants throughout their time on the study. We have also staff that are focused uh within those teams, staff that are focused on the data entry piece of the work and also participant follow-up. So once someone has completed their active protocol therapy, you know, we may be following them as part of the study. Gosh, if we're following them for survival, it can be upwards of 20 years sometimes that we are just routinely touching base with them. And then we also have a quality assurance component. So we have a QA program as part of our office. They do a lot of work not only with our investigator-initiated studies. So I'll kind of once I talk about roles, maybe skip to kind of the different types of studies that we support and why that's relevant. But yeah, the QA program does a lot to support our investigator-initiated studies, not only from the development side, but also once that study is open, the ongoing monitoring and auditing. So depending on the threshold, if it is a study where we, our physician or PI is the sponsor investigator, then we are conducting maybe monitoring visits at other locations, things like that, much like someone familiar with sponsors or CROs recognize that they're doing. And then in addition to that, as part of QA, we have our own internal auditing mechanisms and our education. So again, back to kind of onboarding and training, and then our continuing ed. So things that either we identify through regulations changes, just ongoing process changes which happen all the time, or as we kind of process improve ourselves, yeah, our workflows, which is definitely something that's ongoing. So I think again, like I said, we look pretty similar to other cancer centers and kind of distinguishing the functions within the office in that way. It enables us to have a lot of cross-coverage. I think one of the components of the studies that we support now is they're not all going to enroll a lot of participants. You know, we're now we're in a time of targeted therapies. And from that perspective, we may have fewer patients that qualify for some of the trials that we run.

unknown 14:58

Right.

SPEAKER_00 14:58

But at the same time, the potential of the treatment offering some benefit to that participant who does qualify, it's important that you have that available to them. Our physicians feel that that's important for their potential care. So with that, we have a multitude of studies that are open at any given time. But again, just recognizing that some of the days of having studies that are going to enroll, let's say, you know, 20 to 30 patients at our site are less likely now. And so with that, we have maybe more protocols, but we also have the ability within our staff and teams and the functions that our team can cross-cover each other so that we don't have one expert on a protocol. We we may have three, you know. Oh, interesting. So it helps to support the ongoing kind of ebb and flow of movement on a given study.

SPEAKER_01 16:01

Interesting. That's interesting. Well, and that that actually, just thinking through what you're talking about, and and I know that this is uh an oncology thing that you're talking about, I guess, that that you're seeing in research that that you're seeing more uh targeted therapies and so less people in each study, maybe more protocols, like you said, but less enrolled participants. Uh how does the and and how do you guys manage um I guess your department budgets with say sponsors for studies, how has that impacted that? Because I feel like, you know, if the traditional model is you enroll as many people, and the more people you enroll, the more money you make, kind of thing, how has that impacted you guys?

SPEAKER_00 16:42

Well, I think interestingly enough, we so a couple of comments about that. One, from an industry perspective, I mean, very often, again, it's not out of the question from a feasibility perspective to be saying, you know, we think we may have five potential participants that can enroll at our institution to this study. And so, you know, maybe overall nationally the trial is targeting 120, but it's five of them potentially could be from our side. And from a feasibility perspective, that's a reasonable expectations from the sponsor side as well, right? Sure. But I think so. I think what ends up happening with that is we are looking more at our portfolio overall than we are at a specific trial and the number of patients. We want to make sure that it's worth the resources to open the study. So we do a review to understand do patients with this diagnosis kind of to the level that we can with that pre-screening waiver review that we or approval that we have in place with IRB to say where we look at feasibility to say, do we have participants available for this study that could be candidates? You know, yes or no. Yeah. But beyond that, we approach that in terms of portfolio balance, like I mentioned. So across cancer types, we are looking to see, okay, for this type of cancer, do we have something available for newly diagnosed participants? Do we have something available for individuals who maybe have have not responded to their first line of therapy? Maybe now they're moving on to their second or onto their third. And then, and so we want to ensure that kind of no matter what phase or situation that that individual is in in terms of their care, that there may be a study that offers some alternative therapy for them to what we would call the standard of care. And so that's how our physicians review the study for portfolios within their programs.

SPEAKER_01 19:05

So what do you sorry, what when you talk about the physicians reviewing studies for the portfolio, what what is that process?

SPEAKER_00 19:14

Yeah, so we actually have what we call disease research group meetings, um, where our faculty, physicians, nurse practitioners, members of our study team uh are present at the meeting, they review studies that are open. And we actually we make what's called a trial tree, but it essentially is just what I mentioned. So, kind of for all of the different clinical scenarios that a patient could be in at that time, do we have some type of study that can address that possible need for someone again, providing that potential alternative route for therapy if they're if they're a candidate? Because at the end of the day, not all participants can qualify for a clinical trial, but also the standard of care, they always be available, right? So if at that unique time the trial is the best option, both from the participants' perspective and the physician's perspective, and they agree they want to move forward with that study, then they may have the standard of care to go to as their next line of treatment if it wasn't effective.

SPEAKER_01 20:31

Yeah, no, thank you. And and I mean this makes sense again, thinking of since in and I mean when you think about all therapeutic areas of research that that could happen, right? Oncology is obviously the closest to clinical care, right? Because it's sort of an extension, right? Research is sort of an extension of their clinical care in your world.

SPEAKER_00 20:48

Yes, it's very intertwined.

SPEAKER_01 20:50

Yeah, yeah, for sure. And I and I think that that's helpful to understand too, because okay, so and and you know, you kind of mentioned the budget stuff a little bit about how you guys see the feasibility and whatnot, and you have to make sure that it makes sense to bring on a trial, of course, financially, because you're paying people and all that stuff. But as a program, you're talking about a portfolio. It sounds like how you measure success is not necessarily revenue, straight revenue coming in from clinical trials, right?

SPEAKER_00 21:19

Yes. So tying all of that kind of back together, and where I was going with kind of at, you know, evaluating things at the program level, yeah. We really do measure success by having those alternatives available for for people. We actually we don't financially benefit from conducting trials. We have we have tools in place as an institution. And one of the reasons why I really enjoy working at an academic medical center is we have, as I mentioned earlier, investigator initiated studies. So studies that have been written by our physicians and faculty members. That you know ultimately re uh develop and operationalize. And some of those do have maybe some financial support because they have an extramural grant or something like that. The other expectation is that we also conduct what I call uh cooperative group studies, but there are studies that are funded through the National Cancer Institute. They are typically larger, maybe late phase two or phase three studies for the most part, where the the budget is really just a very minimal payment to support the enrollment in and of itself. But again, we actually just look for uh a zero balance across all of the elements. So can we support the work that we're doing and the people that we need to do it from a quality perspective?

unknown 22:51

Yeah.

SPEAKER_00 22:51

Um, you know, and a and a compliance perspective. And are we uh do we have adequate resources basically? And then beyond that, we're not necessarily looking to generate revenue above and beyond that in continuing our network.

SPEAKER_01 23:09

No, I think and that again, that makes sense, especially at an academic medical center, like you're saying. I guess, but it still sounds like it would be difficult, even if you're talking about a zero, you know, zeroing out your your your budget, it would be difficult to if you have a portfolio and the the sort of directives are you have to have available studies as much as possible, right? For all of these different indications or different phases of of cancer care and everything for your patients, at some point you might not be able to, I would imagine you wouldn't be able to balance it. You still like you have to have resources for these things. And I imagine even in you talk about cooperative groups and NCI gives some funding, but then the investigator initiated, if they don't have uh, you know, other funding coming in, I imagine there are some that are unfunded, like completely.

SPEAKER_00 24:02

Yeah, I would say the proportion of studies we can afford to do that truly have no funding whatsoever, it's going to be pretty limited. True. We have there are some maybe internal mechanisms for pilot awards. We also have um investigators who have partnered with industry sponsors who maybe are providing drug or drug and some funding in support of their project. Many of them have avenues at which physicians can propose studies to them that they then review and approve, very similar to kind of other grant mechanisms, for example. And so a lot of the IITs that I say IITs, that's investigator-initiated trials, but a lot of the studies that we would manage, they do have some support in that way. And it's really quite necessary. And I think that's one of the biggest hurdles for our physicians. And the other area where I see continued opportunity and and value in this is I want to be able to support our physicians and and their and their ideas for studies. I think because they know what they see and experience in their clinics with their patients every day. And so a lot of times their ideas are sort of born from the things, the challenges that they see while they're administering that care. And I think that you know it's important to help facilitate. And I know that's a big hurdle for them is to find a funding source a lot of times when they do have that idea for a trial. And so we try to support them in one, identifying what those potential opportunities could be. I know through our cancer center now, as we've grown, that we've actually developed kind of regular routine communications to the faculty with the RFAs that are open right now through various external organizations, what our internal funding opportunities might be if there are grant funds. And then from physicians and mentoring each other as in their research careers as they grow, they also will help to introduce them to company contacts and things like that, so that when they do want to learn more about the potential to uh actually operationalize their trial, they have those sources that you know they can go to and and ask, you know.

SPEAKER_01 26:36

Yeah, that's super helpful, I'm sure. And it's it sounds like it's a real sort of partnership with the physicians between your what your uh role and function is as a as a sort of uh you know, research administrative support, uh operation support, uh running the trials. I might I was thinking as you're talking about the physicians and and them bringing studies to you sometimes. What how do you bring in in general? How do you bring in studies besides investigators having their own ideas? What what is the mechanism that you guys use to either attract pharma studies or you know, how does that part work?

SPEAKER_00 27:14

Well, um, so again, kind of depending on the the sponsor of the study, but if it's a pharmaceutical company, we have at this point we have established relationships with CROs and companies. So we are often contacted by them. And it may be a direct contact to a member of our team because they again, we have a a team that's very focused on trial activation. So sponsors or CROs have the their names and contact information, may just be reaching out to them versus reaching out to the physician directly, or sometimes they reach out to the physician and the physician will then send it to us. And then if it's some of those national studies, we're essentially notified at the group level, just well, when a new study is activated. But our team will actually go, there's a central portal for those, and our team will go and essentially look at all new study opportunities within a certain cancer disease area. So let's just pick one and say within lung cancer, and they'll say, okay, well, are do we have any new studies in lung cancer? And then at that disease research group meeting that I was um mentioning, they will discuss the new opportunities, no matter what the sponsor's source is. So it could be a again, a pharmaceutical company, one of those NCI-sponsored studies, um, an internal project, and they're they'll discuss it at that time. And then essentially our teams will decide if yes, we think this is a great fit. We have the patients for this study. We don't have a study that's going to compete with it for enrollment, things like that. Um, so they'll they'll essentially vet all the projects within the group at that time.

SPEAKER_01 29:05

So, okay, so then that that committee you were talking about with the physicians, they all the study, the potential studies go to them, they say what they like, then it gets kicked to you guys to do feasibility, or do you are you doing feasibility before and providing that at that committee meeting?

SPEAKER_00 29:19

Once the physician we ask the physicians to confirm that they indeed want to move forward with it as an opportunity before we do the next step with let's say that full feasibility questionnaire. And then it will once they've essentially voted yes, then you know, we'll move it into the activation pipeline from there and just move it forward.

SPEAKER_01 29:45

So then what uh you had mentioned like there are obviously reasons why they may say no, they're not interested, or they don't, you know, think you could do it. I think you had mentioned uh like competitive enrollment stuff. What what is what does that mean? And just so people understand, like how yeah, how does that happen?

SPEAKER_00 30:02

Yeah, so well, I think I had mentioned therapies being targeted. Sometimes there may be studies that really are they compete with each other because of their eligibility criteria. So maybe it's for newly diagnosed haggers cancer patients with uh with X mutation, something like that. But we do evaluate the eligibility criteria. We'll ask for a synopsis. If it is an externally sponsored study, like say from a pharmaceutical company, we request a synopsis, and that's what the physicians are reviewing. So we can take a more detailed look to again, it's it's that first look at feasibility before doing that more detailed questionnaire submission, for example. But we are evaluating it then. Do we have a study open now that may be complete with the enrollment period by the time this study is open to accrual? If so, you know, there's no no competition. If there are similar therapy for or maybe similar in eligibility in some way, what's the rationale for having more than one study open in that area? And they do exist. Maybe there's something nuanced. Well, this one is for participants who had to have received uh prior treatment with uh plat or something like that. I'm just throwing out examples. So from that, you can get a little bit more nuanced and say, so actually, this won't be an issue of enrollment with the same patient population.

SPEAKER_01 31:34

Yeah. That gosh, I mean, everything that you're talking about, I nuanced is the perfect word because not only are you, I mean, you you have a very mission-driven, you know, setup there, right? Like with the the whole portfolio and the the goals with that, and then you have anytime you're doing feasibility for research, and this is just a blanket statement across the board for any research site, uh trying to identify how many people might we, you know, do we think we might enroll in a study like this, given the protocol, given the limited information you have, all that stuff. And then and then the competitive enrollment adds that other layer, obviously. That's like, where is that line? Like, there's not, there's not gonna be, I probably there's not gonna be many protocols that have the exact same inclusion, exclusion, right? They're not gonna be verbatim necessarily, but to your point, you have somebody has to assess this is either close enough that it doesn't make sense, we don't want to step on our toes to try to enroll in both, versus, like you said, maybe there's something slightly different that, but then at that point, you know, if it's slightly different, then you're still left with the problem of you come across, say, one patient that could be eligible for both. Do you push them into one direction or the other? Do you give them the option? Like that's a just a lot of nuance there.

SPEAKER_00 32:50

There is, and I would say normally they're presented with the option, again, recognizing that each study also has requirements of the participants. How often are you asking them to come in? You know, what are what are sort of the the maybe the extra things that they're going to need to do? So, you know, that at that point they have the they can decide what they might think would be the best fit for them and that they would like to move forward with. And then ultimately in that case, if they for some reason were a screen failure for that maybe first first choice, and then maybe you know, then everyone collectively decides to move to a second. But to your point, I think the other aspect of all of this is not just opening. We we try to be good stewards in opening the right studies, right? So ensuring that you are opening protocols where again you there are there is a need, not only within your portfolio, but that you have the population available, you have the resources available to do it because of whatever the maybe that study's requirements are. But beyond that, once a study is open, we do evaluate each in an ongoing way. So every six months within our office, every study, so both at the beginning and then in an ongoing way. Every study receives a scientific review. But the scientific review committee, the ongoing mission is to evaluate how they're performing from an accrual perspective. So are we meeting our accrual goals for this? If not, is there a specific reason why? Or is this a very rare population where maybe it's just going to take an extended period of time to meet its goals? And the idea of that is just again, are we being good stewards of the resources? So ultimately, if we have a study open that no participant is able to enroll in, well, then we may want to consider closure of that protocol so that we can have the opportunity for something new to come in that is something that is better to have available for participants.

SPEAKER_01 35:03

No, that's actually nice to hear. I think just in general, for people to understand that that's an ongoing um thing that you guys do, right? That you're constantly looking at stuff, because I know that that's obviously a problem in research in general. A lot of sites will open up studies thinking that they can enroll patients, and it and then they they don't end up enrolling and they just keep it open forever. And and that's just obviously you're just you know digging the hole deeper. But again, all of that stuff takes resources, right? Like all of that takes time, energy, people to do that assessment to regularly check back in with the studies. Like that's a lot of so tracking metrics, all of that, yes. Yes, yes. So then I guess from that side of it, what what do you I mean we people talk all the time about the the sort of burden of technology at the site level? I mean, I imagine you guys have quite a few systems, you know, that you're using. And I assume that you have systems that sort of live within your cancer center there for for your research program. Uh what does that look like? What is your what do your technology solutions look like?

SPEAKER_00 36:12

So we do use e-regulatory, that's 21 CFR Part 11 compliant, so we can facilitate electronic signatures, which I think is definitely a very helpful tool. And then uh we also use a clinical trials management system. So from my standpoint, that's just a must-have across hundreds of um studies looking at timelines, enrollments, screening, and and and enrollment information, those kind of things, and being able to pull reports at uh as I mentioned, like I can pull reports to look at a specific program. So let's say I wanted to see all of the studies we had open in breast cancer and for how long they've been open and what the accrual was and those kind of things. I can do that at any point. And I think for me and all of our teams, honestly, just something that's very necessary, not to mention kind of the components that go along with just having a study open. You need to have means of notification. So when studies are amended and there are new requirements or new consent forms and you know, just things. I think having some of these tech tools, as you mentioned, is very critical because we're really able to use them for these purposes, ensuring we're getting the right information to the right people at the right time, that we have a reference for when we activated that amendment from a regulatory standpoint, for example, that we can track who, you know, if there were five participants, that three of the five have reconsented and two are left. And that kind of thing, again, across the whole portfolio. I think the the technology certainly helps with them, the tracking of these unique needs, and then also, like I said, the ongoing metrics of them.

SPEAKER_01 38:07

Yeah, I mean, it sounds like that's absolutely necessary. You wouldn't be able to to do it at scale like you're doing without those tools. And and I guess to to think about your uh world and and everything that you're sort of in in charge of there or leading or whatever, what is or it could be a couple things, what what are the the biggest challenges that you have in terms of making sure that the infrastructure, the resources, and everything else are in place to meet the goals and you know, and be successful as a cancer center?

SPEAKER_00 38:42

I think some of the biggest challenges are actually in operationalizing a study, not so much from our resources. I think you know, you have a great perspective on what you've built within your team, but we mentioned earlier on that our studies are very intertwined with the healthcare system and with patient care. And so it's just we're trying to do something that many times we're maybe asking for extra things as part of study conduct that are just difficult in an environment where clinics, hospitals are busy, and they don't have a lot of extra resources either. And so we want to make it kind of as as insert ourselves into the process without disturbing the process as much as we can, if that makes sense. It does. So we we have to we are there to ensure that these the protocol is followed to the best of our ability, that we're meeting all of the study requirements. And so there's extra communication tools that we have between maybe our coordinators and the infusion suite nurses, for example. And so all those kind of extra things are, but they're just necessary to be able to ensure that we can really address all those study requirements in a way that, like I said, doesn't disrupt necessarily that nurse's day to the best that we can, but we know we need, hey, we have to draw PK samples at 15 minutes, 30 minutes, 45 minutes, three hours, six hours, eight hours, those kind of things. And so a lot of our team's focus not only is on I mentioned process improvement. So we do process improve ourselves, but we actually have some methods within our own office that we do. We have a process improvement committee, and anyone on our staff, we can you can just submit via red cap if you have a need or you think, hey, we should take a look at this workflow that we wrote. Maybe it needs updated, that kind of thing. But we also spend time meeting with the clinical staff because we want to understand what is the best way to communicate with you? Is it within the treatment plan in Epic, or is it something that's going to come to you outside of Epic? Is a physical piece of paper more helpful for you to record this information, or would you rather chart on it like you do your other requirements? So those are all the things that we want to understand from the teams and get their feedback on. Because, like I said, we want to make it as easy for them to help us with the protocol compliance. Yeah, and document everything you need to document for a research study.

SPEAKER_01 41:45

Yes. Well, and and I think that that is a that's such an important topic in general for especially when you're talking about research in a in a clinical setting, and then in the oncology, you add that extra layer. But like incorporating research into the clinical care model is you know what I mean. It's and and I know that that sort of it's not a debate, but some people disagree about how close those should be. Uh, again, oncology is is is unique and different because you're still left with even in oncology, you're left with the situation of making sure that the research participants understand if they're in a research study, it's research. And if they're in clinical care, they're clinical care, right? Like even as, even when research is an extension of, meaning there's no other clinical option, so then it it gets sort of uh you know moved over to research in your world, having that bridge, like I guess the shorter that bridge is between you and clinical, the better for everybody. But then how do you I guess I'm I'm thinking out louder asking you at the same time, how do you make sure that they also understand that research is research? It's not a, you know, it's not something that their doctor says or should necessarily say this is going to work for you, right?

SPEAKER_00 43:02

Yes, that's a really great question. I think a lot of that does go back to the time of consent and then the concept of ongoing consent. I I think we have some pretty, I would say, distinct workflows around actually obtaining the consent and the time that our team members spend in reviewing it with the participants. We ensure the physicians are involved to talk about the treatment aspects of what what the drugs are, for example, and and what the potential side effects of them are and again how they may not benefit that participant. But our team also spends additional time going through when sometimes the consent forms are what 50 pages long. I I mean just reviewing them with the potential. Participants and then using teachback methods throughout the process to ensure that to the best of our ability that there is a level of understanding there that this is a study and that these are the the aspects that are the hypothesis of the study. This is what we don't know, this is what it's testing. Right. Um, this is how this is what's extra for you. Maybe you know they're being asked to complete an extra clinical procedure that they wouldn't have otherwise had. And so explaining what's extra for them. I think one of the most challenging aspects for everyone is when it comes to actually the the financials. So I think studies are very clear in explaining now on consent forms what is paid for by the study and what isn't. But we do get a lot, you know, still questions on those aspects.

SPEAKER_01 44:57

Questions from who?

SPEAKER_00 44:59

The participants. Okay, okay. You know, maybe they were just about the bills that they received from the hospital or something like that after the class. But ultimately, we there's there's always components of this that are, like I said, standard of care. And so kind of all of that is happening at the same time outside of the study. And so it gets a bit confusing and and and I know for the for the patients kind of trying to understand all of that information. So we have again do our best to go over what is paid for by the paid for by the protocol. And a lot of times just the fact that the treatment itself is covered can hopefully be a financial relief. But otherwise, I know that's uh something that's can we'll ultimately refer them over to the patient financial resources just because our research team talk about kind of working in the an environment, but not necessarily being involved or educated around all the components of someone's insurance and how things get built. You know, we're just referring them to the experts to go through the details with them. Yeah, in hopes we can help them resolve and just be available to answer any questions.

SPEAKER_01 46:24

So now and then I assume that I mean you said you meet with the clinical staff. I assume the patient financial services folks have at least some level of awareness and understanding of research, right? To be able to sort of talk to patients about both sides. Because that's you uh it that is that's a very difficult situation because I don't I don't know anybody that understands insurance. I I don't understand it, right? Like when it gets into hospital clinical care, um it feels like it's made up, but uh like understanding that side plus the research side, it is it's two worlds, it's complicated, and again, nuanced to get back to that word, but that'd be tough for the patient.

SPEAKER_00 47:03

They are aware, and and you know, many times because there is a standard of care component involved in our research studies, the studies consent and treatment plan and things like that are actually involved in the pre-certification process, just like maybe they would be for any routine care item. But I mean, our a copy of a signed consent form was provided to that participant's insurance company uh for review and and verification. So yeah.

SPEAKER_01 47:39

Yeah, no, that that that would be a challenge, like you said. And and again, the idea that, like from the onset, you guys are trying again, like you said with that committee, you're trying to have a portfolio that is in in true service to the patient and the patient populations that you have. Um I mean, the biggest, I would imagine it would be the biggest sort of frustration to on the other side of that, once these people are in studies, to have those kind of headaches, right? The the misunderstandings and like how do we make sure that they are fully informed of of how this works and what's going on? Yes, that's that's a lot.

SPEAKER_00 48:16

Yes, it is.

SPEAKER_01 48:17

So uh Michelle, this is this has been fantastic, and I really appreciate you kind of talking through uh your program and how this sort of all works. I think this is again a side of research that a lot of people don't have uh access to, obviously, if you don't work within it yourself. Uh you talked about what it means to be uh successful, right? At the beginning in sort of the portfolio and your mindset, I guess. But how do you how do you know that you are uh successful? Does that make sense?

SPEAKER_00 48:45

Yes. Well, I I would say if if you asked me about it in terms of metrics on paper, I you know, we do evaluate ourselves in an ongoing way based on two things. One, so we know the number of individuals that maybe come to our hospital, our healthcare system that have a cancer diagnosis. And either they've come here and they and were diagnosed with cancer here, or they came here for an you know, maybe a second opinion and then went on to receive some type of therapy here. And so ultimately we know one of the ways we know we are successful is because I can look directly at those numbers and say of the number of individuals that came here, did you know, were we successful in enrolling them to clinical trials? Meaning we had meaningful studies available for them in their care.

SPEAKER_03 49:46

Yeah.

SPEAKER_00 49:47

And so I can really point to those numbers in an ongoing basis and say, okay, did at least 15 to 20 percent of the individuals that came here receive some type of therapy or enroll or participate in a study?

SPEAKER_03 50:03

Yeah, okay.

SPEAKER_00 50:04

And then the the other way we evaluate that is honestly through our community. So individuals that live in our community area, how many of them come to the center, those kinds of things. So we're constantly looking at our ability to do community outreach, education, and engagement because we want people to know that they don't have to travel far to receive good care. They can, yeah, you know, we're right here in their backyard and we have these options available for them, not only from the treatment perspective, but we have studies about cancer screening and prevention. And then once they complete their treatment and they're now in what we would call survivorship, but maybe still experience some effects physically from from having had cancer at some point. And so were we able to reach them with our studies? Do we have are we when we ask them about their needs, are we addressing them through the research that we're doing? And so we have that open dialogue going in the in in an ongoing way, and so I think that's really kind of the the mission for the whole program is not only from the number of people coming in, which like I said, I can look at that on paper, but when we're talking with people in the community, I mean I've I've been to our we have a community advisory board, I've been to meet with them several times and try to keep that conversation ongoing, but just understanding what their specific needs are, what they hear from their neighbors, and you know, do they know that they can come right here to our cancer center to get the care that they need? And you know, that there's actually more than just to that medicine that we can help them with. So yeah.

SPEAKER_01 51:52

Oh, that's fantastic. Well, I love it because again, this is obviously a very mission-driven program that you have, and and talking about your metrics and how you measure success, it sounds like you are a hundred percent targeting the patients and what what they need. I mean, it makes perfect sense, but it's also just nice to hear that spelled out. You know what I mean? Yeah, like this is why this is why these programs should exist, right? And and however they come in from your studies, whether they're investigator initiated or from sponsors or the cooperative groups, like you're focused on on helping the patients in your community get the care or access that they need. Um yeah, that's that that's very very cool. Well, thank you again, Michelle, for taking the time to do this. I feel like this is again, it's so nice to understand that I feel like a lot of the administrative sort of, I'm just administrative is a big umbrella, roles in research. If you're not specifically the PI or the coordinator running the trial or whatever, a lot of roles like yours, I feel like are kind of elusive and like what do they what do they do? And like what does it take to, you know what I mean, to manage a program like that. So thank you for kind of walking through and explaining how how a lot of this stuff works.

SPEAKER_00 53:05

Absolutely. Well, happy to talk. I feel like I uh touched on a a portion of it. Um day, I'm sure. On what you're doing. But certainly, uh yes, definitely uh it takes a big team to do all this. So uh I think I'm pretty fortunate here to work with such amazing colleagues. So but yeah, a lot of a lot of smart and dedicated people are are doing this work. So excited to talk with you about it.

SPEAKER_01 53:36

That's awesome. Well, uh keep it up, right? For for everybody's sake, and and we appreciate it. But uh thanks and and I'm sure we'll talk soon.

SPEAKER_00 53:44

Thanks, Justin.

Brian Blackmon

SPEAKER_01 53:47

I hope you enjoyed that conversation with Michelle. It's encouraging to hear from leaders who are so thoughtful about their role and are always working to improve the systems they're in. And speaking of encouraging, my next guest on the research participant side is Brian Blackman. Brian has an impressive career in clinical research himself, but today we talked about a different side of his experience. Brian is the caretaker for his dad who enrolled in a clinical trial last year. I've talked to several research participants, but we don't always get to hear from the caretakers, who, as you'll hear, play such a necessary and vital role in the research participant experience. Brian not only shares his personal story, but he also shares a little about how his experience as a caretaker, combined with his industry experience, led him to actually create something that solves a real problem in our industry for participants and caretakers. It's a wonderful discussion. So without further ado, I hope you enjoy my conversation with Brian. I am super excited to have Brian Blackman here with me. Brian, thanks so much for being on the podcast. Yeah, thanks a lot, Justin. Thanks for the invite. So I want to talk you. You have a very fascinating and interesting story that you're going to share, I know, about sort of being the on the caretaker side of taking care of somebody that's been in a trial. Before we get into the story, do you mind telling us uh a little bit about yourself and sort of how you came to where you're at now? Sure, yeah.

SPEAKER_02 55:11

So I'm one of these people that kind of got thrown into the world of clinical research by accident. I think a lot of people have this story actually. So I was never like I went to college and said that's what I want to do. But through a series of kind of like trial and error, like doing other jobs after graduating, I found this world and I actually really enjoyed it. So I throughout like, you know, the last 17 years or more, I've done just about everything you can do in like the clinical trial world. Um done study, startup, monitoring, closeouts, statistical reporting, kind of all of it. Was like doing some really cool stuff in like the decentralized clinical trial world before it was even a thing, like you know, traveling to people's homes and actually collecting biospecimens and things like that. It was just really, really fun stuff. Yeah. But like with most people, I kind of at some point you get a little burned out and you're like, this is this is a lot, and there's a lot of it it's a tough job. Uh so I did take a little break and I went and worked on the payer side of the industry for a little bit, which was incredibly interesting. And I kind of feel like I need to say this because I I tell a lot of people this. I think that more people who are doing clinical trials should have that experience. Because from my perspective of like doing this work, yeah, I always kind of thought that the the the whole world is just from drug discovery up to FDA approval. And then it's like everything stops. And what I realized really quickly was these big pharma companies, especially that's not true at all. Like that's when a lot of times they think the work actually begins because they've got to get it to market, they've got to get it to people, they've got to get it on formulary and get people to use it. And yeah, it was a very interesting experience. But after doing that for a little bit, I had the opportunity to come back to where I work now, which is the Duke Clinical Research Institute, to help with their innovation center called iCubed. And so it was a nice change because I'm most definitely still in kind of you know the day-to-day of what the clinical research world needs and areas to make improvements, but it's no longer the kind of grind that it used to be. So that brings me up to what I've done and where I am now.

SPEAKER_01 57:20

Yeah, that's awesome. No, that's a great background. Well, and I think that'll and and you'll I know you'll touch on this in the in your story, but I think that uh your background sort of helps to shape what your experience and and and give a lot of not credibility, but a lot of insight, I think, into what's happened and stuff with your story as a caregiver. So I guess let's jump into it. If you don't mind, sort of let's start at the beginning, kind of tell us how this came about and and what what we're talking about here with the clinical trial.

SPEAKER_02 57:50

Yeah, so um you're right, because it does kind of shape, I think, leading into this maybe differently than other people. Because after doing this for so long, you kind of think like, oh, I'm ready for whatever people are gonna throw at me. And so it all it all became very different when my dad, well, so let's step back, like you said, about eight years ago, he was diagnosed with cancer, multiple myeloma, which is a blood cancer. And it was kind of a a long and difficult diagnosis because the weight usually presents itself is through back pain and things like that. And he's had back problems basically his entire life. So it was disguised in a lot of other things. He eventually he got diagnosed with it. He got put on in a the standard of care for chemo, he had a stem cell transplant and actually responded quite well to those. And the for his specific case, it was never like something where you know he sat down with a doctor that was like, You've got 18 months to live or anything like that. They were like, We think that this is very manageable, we think that we can, you know, we can't cure it, but we can definitely try to treat this for as long as possible. Yeah. So the caregiver side of this was really interesting because this is even before he was ever enrolled in a clinical trial. This is just like, well, now somebody has a cancer that requires weekly chemo infusions. And so, you know, how it and the because it was uh a cancer that resulted in a lot of physical pain, he couldn't drive himself. And so my mom ended up being very involved in this, like, you know, driving him to all of his appointments while she's still working. So that was very difficult. And they managed it for a while, and thankfully, throughout that, since that happened eight years ago, since then my mom is retired and in her wonderful retirement now, like this is what she's doing is taking care of my dad and driving him to and from doctors' visits.

SPEAKER_01 59:41

Yeah, oh my goodness, that is a lot. It's it's a lot, like you said. I mean, for somebody that anybody that kind of has any kind of diagnosis like that, like your the the the caregiver aspect is such an important part of that, right? Like you just can't nobody can manage that on their own, right? Right. That's yeah.

SPEAKER_02 1:00:01

And so my dad enrolled in a clinical trial about a year ago, but before that, he had another opportunity to roll in a clinical trial, and everybody actually was really excited about it. But then we found out that he was not eligible due to the fact that he had already had a stem cell transplant. So, like there was this opportunity where we were like, hey, here's something that you might qualify for, and then we realized, oh, actually you're not. So it's kind of like that roller coaster of emotion, which I hear a lot of people talk about. But then about a year ago, there was another opportunity for a trial, and this was actually a um it's it's kind of like a drug added to standard of care therapy kind of thing. So it makes the scheduling quite difficult. I'll say that. But the interesting piece was my parents know that I work in the clinical trial industry, but they don't really know what I do, and it's like kind of hard to explain it to them. And sometimes when I tell them like really what I do, they just kind of shake their head and they're like, I still don't get it. But um, yes, yes.

SPEAKER_01 1:00:59

I think everybody that works in the research industry right now listening is like, yeah, I've had that conversation with my parents. Yep.

SPEAKER_02 1:01:05

Yeah, my dad's like, you're not a doctor, you're not a nurse, but so anyway, so he calls me up and he's like, Hey, so I have another clinical trial, potentially. I just left talking to the nurse, and I've got like I want to talk to you about it. And I was like, Absolutely, like this is my time to shine, kind of thing, right? Like, I can come in and show you this. And my mom, who has historically been kind of the one to help with this care, she was like, I don't know what any of this stuff means. And I was like, Don't worry, I'll help you out. I got this. So eventually, one of the first problems that I realized with trying to share information about a trial with caregivers is that I was like, just email me over the forms. Because in my line of work, if I I email consent forms to colleagues or to whatever, to sites, and I'm like, here you go, and all this kind of stuff. And he was like, Well, it's sitting on my kitchen counter. How am I supposed to give it to you? And I was like, Oh, of course, right. So there was a time sensitivity to this. He needed to make a decision soon. So I was able to go over there and I sat down and I looked at the consent form, which at that point was pretty much all he was given. And it was dense, it was so dense, it was like 55 pages long. And the nested within that was a schedule of events that had all because it was tied to standard of care, it was just like incredibly confusing. And my parents were just like, we really don't know what to do. And they were basically looking to me for guidance, right? What should we do? The the the the PI, who was also his oncologist, okay, was incredibly helpful, right? He was like, I'm happy to answer any other questions you have. His nurse, who was also acting as the coordinator for the trial, that's not her full-time job. She is also a nurse for his regular oncology care as well. So one of the first things I did was I was like, let me just call her and see if I can get some basic stuff answered. Yeah. And she was like, I have to be honest with you, this is I I don't, I'm probably not the best person to ask this to. This is a fairly new trial. I've got a cheat sheet here that I'm looking at, and I don't really know the answers. You could try calling the PI, but he's not going to be able to take your call for a while. She was like, Why don't you try calling the nurse navigator at the oncology center? And so I was like, Okay, so I called the nurse navigator, and she was so incredibly nice, but she was also on the verge of tears because she was like, I'm one of two nurse navigators for the whole cancer center. And I really don't know. She was like, Do you need an Uber ride or something? And I was like, No, no Uber ride. But yeah, it just, you know, it was incredibly, I guess what I'm trying to say was incredibly eye-opening for me, because in my mind, I'm I've been the on the other side of this. I've been people creating consent forms and creating study documents, and said, sure, anybody would understand this.

SPEAKER_03 1:03:56

Yeah.

SPEAKER_02 1:03:57

And the other piece of this that I really had never considered and always taken for granted is that from my dad and my mom's perspective here, and now my perspective, there seemed to be this urgency to everything. And there wasn't this luxury of being able just to sit around and say, Well, let's think about it, and I don't know, come back to it in a week or two weeks, or it'll try to answer as many questions as we can. Because they were like, He can come in, he needs to come in tomorrow, basically, to start. Yes. Wow. Anyways, long story short, he enrolled. Yeah, okay.

SPEAKER_01 1:04:34

He's uh so you just took, I mean, at that point, you didn't get really any answers. No, I didn't.

SPEAKER_02 1:04:39

I didn't get and and it was the questions that I had were more about kind of the logistics of things. The consent form did a great job of saying, here are the risks, here's kind of what the what this study is trying to accomplish. But I was trying to figure out how many more times is he gonna have to go into his to to see his doctor. Are these gonna be concurrent with his regular visits? Are they gonna happen at different times? And yeah, we found out later, because this wasn't in any of the documents that he received, is that they weren't actually concurrent. It's this totally new visit and all this kind of stuff, but but that wasn't clear just looking at the documents, yeah. Was it wasn't clear, and the his nurse is amazing, like really, really great. But she was also like, I I am not quite sure either.

SPEAKER_01 1:05:26

So yeah, well, that's crazy too, because to your point, you know, uh because of the urgency and because like they wanted to start tomorrow, the logistics that you're talking about, I I'm just it's like asking somebody to to can you commit today to date somebody for the next six months, but I don't know what the commitment level is. Like how many, how many times am I supposed to take them out? How many you know what I mean? Like all of the legit what is the commitment level that I have to say yeah, that I'm saying yes to right now. And if I don't have those answers, I still have to say yeah, that's a that's a tough spot to be in.

SPEAKER_02 1:06:00

That's right. And there's the other piece in all of this is my my dad in particular really, really trusts his his doctor, his oncologist. And so, in fact, so much so that he's one of these people that like the oncologist moved from one hospital to another. My dad followed him, like went said, I'm gonna pick up all my care and I'm gonna go to this new new new place. So I I think what my dad wanted, which the doctor wasn't gonna say, my dad basically wanted him to say, do this or don't do this. Just give him, like, you know, don't don't turn it over to me to say like this is now your decision, because my dad didn't know what the like, you know, to your point, like didn't have all the information, didn't know what was gonna be best for him.

SPEAKER_01 1:06:43

Well, you know what, that brings up a good point, Brian, because you and again, you being in this industry, you know, we talk all the time, as you know, about increasing enrollment. Like, one of the ways that we talk about increasing enrollment is to get the physician more involved, right? If they're a PI, like the if they go to enroll somebody or they explain a study or give a study opportunity to one of their own patients as their clinician, people are much more likely to say yes, for this reason. To your point, your dad uh really trusts his physician, his oncologist. Well, at the same time, if you're used to your oncologist giving you clinical advice, and in the clinical side, they're saying, I think you should do this. In the research side, now they have to take off that hat and say, I can't tell you I think you should do this, I'm just giving you the opportunity. That is it's sort of a an awkward kind of like, Well, I'm looking for this person to just give me the same kind of clinical advice that they've given me in the past, and now they're not. There, it's more vague and like what is going on. So, yeah, that's pretty tough.

SPEAKER_02 1:07:40

Yeah, and I think that that kind of relationship just to what you're pointing out has like already been established, right? Like, there's um it nobody wants to call it like a power dynamic because that's not maybe a fair way to categorize it, but there is this understanding from my parents, and I think it's shared from a lot of people, not just in clinical trials, but uh people who are patients, to say, you are the one who knows more about this than I do. And I'm looking to you for for guidance here.

SPEAKER_01 1:08:09

Right, right. And and when they didn't get that from their oncologist, they came to you, right?

SPEAKER_02 1:08:14

They came to me. Yes. And uh I I think I I probably more than anybody am like the biggest advocate for the good of clinical trials. Like I think that we could clinical trials are great. We don't I actually don't think we hear enough about the positives of clinical trials. I would love to get a panel basically of just like success stories of clinical trials. But even me in that perspective, it was hard for me to just blindly say yes, do it, you know? Right? Yeah, well, I mean, when you don't have all the information, like you said, that's tough. Yeah. So the but but I guess one of the other things that and this is probably the biggest piece, is that we've spent I don't know how much time now just talking about the decision making about like whether or not you actually get into the trial. And I realized that's kind of when the job begins, right? So then you know, my dad's job and my job as like you know, helping him navigate this, his actually the visits that he has are local to me. So he drive he travels for them. Um that's when it all starts. So I show up with him, I sit down with him usually beforehand. He has to do kind of this like an e-diary, basically, to like you know, track how he's feeling, any symptoms and stuff like that. Yeah, if he were left to his own, he would not do any of these things. And I don't think that that is unique to him. He's of a certain age and just overall like use of technology that I think he he would probably before doing any of that, he would write it down in a notebook and hand it over to his nurse in in person. But I think this is very important because in all of the engagement that takes place in his trial, meaning like the reminders to like do your e-diary, like here's when your appointment is, and all of that, there still is this that there's not a clear integration point for caregivers. The the messaging is sent to him, the reminders are sent to him, yeah, and that's kind of where it falls off. And I'm trying to actively push myself into the conversation. And when people realize that, they'll they'll loop me in more. But his phone number's in the database, his email address is in the database, and it's not mine. And so I've realized now that there's this system that's not set up very well for pulling in caregivers.

SPEAKER_01 1:10:32

That's a good point. That's a really good point. Yeah, I think the assumption, again, on the research side is that if you know you you inform them through the the consent process, not just the document, but the process, obviously, tell them what's going on. If they say yes, they want to be in the study, then, you know, they understand they're gonna do all this stuff. And and the the compliance piece of it, I think, is is an assumption that the research side makes is that, yeah, of course, people will fill out their e-diaries and you know, because again, we've built in these processes and it's all process stuff, which is reminders and text messages and my chart notes, and you know, whatever it is. Like, here's just a a reminder of your visit coming up, and so then we just assume of course they're gonna do it, and yeah, that doesn't happen very often.

SPEAKER_02 1:11:19

Yeah, and I do think that there is a a group out there that will do that, right? Like, this is not to say that those things aren't useful across the board, but I mean I can tell you now, from my experience doing this with my dad, and interestingly, because people of his age and whatever, they they they just talk. And so now when I show up with him at a like he knows everybody there, and he knows everybody else basically who's in the trial. And so they talk about this, and uh that I I've confirmed that it's not just an isolated thing, he knows all these people, and they all talk about how you know they're all there with their caregivers. Sometimes it's is sometimes it's a kid, sometimes it's their wife, a lot of times it's like a neighbor or somebody who just drives them because a lot of these people like can't really drive themselves very easily. Sure. My dad still can't drive himself, and so again, when we think about let's get people to stick through the trial, let's get people to be engaged, to show up on time, to remember what they're supposed to do and actually do it. Yeah, I think we've not done a good job of arming everybody around that person with the same information because it's really hard to do all of this alone. And so, you know, I've I've I've thought now long and hard about how can I get as much information about the trial as my dad because I want him to be a successful participant. I don't want him to not do something correctly and cause a protocol deviation or drop out or something like that. Right. Right. But but it's just amazing how much work it takes from others to keep that from to keep that to uh to happen. So absolutely.

SPEAKER_01 1:13:02

Well, and I think uh built into your story, obviously, you you were obviously you said close enough to your parents that you drove over there to review the documents. I mean, most people don't have that, you know what I mean? Like what if they don't have the ability to drive right over that day or the next day to review? How do you get how do you get the information, right?

SPEAKER_02 1:13:23

That's right. And it's I think then what happens is, and I'm learning more about this, people are looking for information. If they can't get it from their doctor, they can't get it from their coordinator, or they don't have somebody to drive over, like you said, they're gonna look to their neighbors or their friends or people who they may know who may not have 20 years of clinical research experience like I do. Right. And I mean, good, good on them for actually trying to get answers, but it's also they should they shouldn't have to work that hard, I think.

SPEAKER_01 1:13:54

Right. No, I agree. I agree. I mean, but yeah, it should not be this hard. We have the technology, you know what I mean? Yeah.

SPEAKER_02 1:14:02

So the other uh interesting thing in all of this is that I did a side experiment in this where I took my dad's trial documents and I uploaded them, basically created a version of this because uh an e-e-binder basically of his documents. And one of the reasons I did this is because his primary care doctor was also really interested in his trial, which was basically because my dad has other comorbidities and he was just like, Oh, you're in a clinical trial. Well, tell me what it's like. And you know, he you know, did really know all the details or whatever. And so I did this, and it was basically like a way, because again, when you think of caregivers, caregivers span a pretty wide swath of people. Primary care doctors are most definitely a very key stakeholder as a caregiver, and it was a success in that my dad was able to share this information with the primary care doctor who logged in, looked at everything, all of his documents that he had, and said, This is really interesting. And he my dad didn't have to fax over documents or wait until his next visit three months from now to hand over a folder of papers and all that kind of stuff. So it was it was pretty cool. And I think that it's just another example of how we've built, I think, technologies for lots of other stakeholders in in running a trial to do this stuff, but we haven't really yet put a lot of resources or effort into making all of this information and decision-making ability in front of participants and caregivers.

SPEAKER_01 1:15:35

Uh that's a that's a fantastic point. I I mean, I'm just thinking in terms of you're talking about like solutions or or you know things that have been developed in the research industry to your point that have been created just to make things either more efficient or make it whatever. If it's efficient or just to improve the process or whatever, there are a million of those products out that help the pharma companies, that help the research sites, right? Like the coordinators, they all I mean, all of them have you know the CTMSs and systems and e-reg binders themselves, right? That that manages all the research stuff. I can't think of anything that is literally just geared towards patients that uh helps them, right? Like, you know what I mean? Like what you're describing is like a a binder essentially that they can own. Like as a research participant, your dad owns that stuff. Like, this is his study, it's his documents, he can share it with his physician, share it with you. Like, that is that's a great concept.

SPEAKER_02 1:16:39

Yeah, it it changes the role of a participant at that point, right? Like they are more, they have more ownership in this, they have more vested interest in this. It's just like now I was actually talking to somebody the other day about how when you buy a house now, or you we're we're not at the point anymore where we hand over like big giant stacks of papers to people after they buy a house. You get documents emailed to you and everything. And so it does seem like we're at a point, like a tipping point where participants, caregivers, and other people have been really kind of left behind for quite a while as it relates to this being pulled into the process, being pulled into the decision making and everything. And I'm not talking about early on, like, you know, let's develop protocols that have patient input and stuff like that. I think we've done a lot of really good work with that. It's sort of like, okay, after somebody's enrolled, they deserve more than just a folder full of papers.

SPEAKER_01 1:17:33

Yes. No, I'm with you because I'm thinking on the clinical, this is the problem, right? Like research, to your point, you've had this experience in your past, you said when you went to the payer side of of understanding how research fits within the larger context of healthcare in general, right? And and that world. In the same way, I feel like clinical care, they've they've already addressed this problem with my chart, right? Or whatever their system is for that. And so now, and and you know this too, but just for for patients on the patient side, I know a lot of systems have tried to utilize my chart for research purposes, but again, all of those bells and whistles benefit the research teams, it benefits the physicians, it benefits the the PIs, whatever, the coordinators. It doesn't help the patient themselves. It doesn't actually, you can't go into my chart if you're in a research trial and understand what your study is and your visits and all that stuff.

SPEAKER_02 1:18:28

So you're talking about something completely separate, sort of like a My Trail, I guess, but for the research side, I yeah, I just never and the other thing that I'll tell you after living this with my dad and being the one who drives him to his his appointments, and the biggest questions that I had were not really things that could be found in the protocol. It was stuff like where do I park? How do I get my my parking pass reimbursed? All of these kinds of things that again, people get that, but they get it in a piece of paper that gets crumbled up and potentially lost and forgotten. And so I think that there's again, I as a participant, as a caregiver, I think that there's a lot of really valuable information. Sometimes it's stuff that's not even in a protocol, it's not in a consent form. It's really these logistics things that help keep people, it gives people, I think, overall a better experience.

SPEAKER_01 1:19:27

I I think that's a great point. And the the wayfinding, like where to park, that question would obviously not gonna be a proto-power consent, but that's something a caregiver typically would need to know, right? Like in a lot of cases, like as in yours, you would be driving your dad to these appointments. He's not necessarily thinking, I don't, I don't know, like he's just in the car and you're driving, so you know where you're going. You know, take me to my appointment. It's like, but I if nobody's told you where to go, especially if you get down to some of these hospitals, man, they're it's like a maze. Yeah, it's on purpose.

SPEAKER_02 1:19:58

That's right. Because then once you once you find the building, the job started, you know. Then it's like, okay, which hallway, which elevator, and they're all like, I'm there literally with a map that's printed out. It's like, look for the purple arrows, and then go down a floor, and then you'll see a green, like smiley face on the wall. Yep, it is it's a literally that's right, yes.

SPEAKER_01 1:20:17

But but I mean, I think to your point about uh a system and and so you said that you've you've sort of created the system on your own.

SPEAKER_02 1:20:24

It was it's you said it started out as sort of a it started out as just kind of a uh like would this even work? Yeah, and it did work, and so I I did as much as I could with my limited technical skills, and then was really fortunate in that a good friend of mine is a real true builder of these things. And so I've worked with him and he's built to together we've put together a what I think is a tremendous resource for participants and for caregivers, and it essentially takes all of these documents that people receive, it puts them in a digital place that you can have access to, you can share it. So, like my dad can or my mom or whoever wants to log in and say, I want Brian to have access to this. Yeah, I can log in and I can see all of his uh everything that he's doing. I can follow up with my dad to say, Hey, by the way, did you know that X, Y, or Z was going to be happening? And just make sure that he's prepared. But it but but another thing that we did that I'll say really quickly, because I think it's one thing just to give people documents that that solves part of the problem. The other really interesting thing is that when you have those, like this was the problem that I had, my dad has, my mom has. Looking at that big stack of papers, you really have three bad options if you have a question. One is you can hopefully find the answer in those. He didn't know which document to look for to get the answer. And then if he did, did you actually understand it? The second thing is you could call your coordinator and ask them. And I will tell you this now. Every single time I go to a visit with my dad, yeah, the nurse who is treating it, her phone is just like buzzing nonstop with, you know, somebody's got a question or somebody's late, or can you reschedule this or you know, whatever? So we don't want to continue to push questions to coordinators, trying to figure out is there a deflection or a support way to do this. The third thing that people do, like I said earlier, is they're going to social media, they're going to ChatGPT or Reddit. Interestingly, I found a Facebook group that was very specific just for my dad's clinical trial. Seriously, is it like just for his trial? Yeah, you had to like request to join. Of course, I requested, I got in. Nobody asked me for any kind of like verification that I was in the trial. It's amazing. But it's people sharing information about the trial. And so again, they people are looking for uh for this information. But what I was gonna say is that just giving them the documents doesn't always solve the the problem. What we do is we now allow people just to ask questions about their study, and they don't have to know which document has the answer or how to interpret it. And what we do is we scan across all the documents that they've been given, we find the answer, and we put it back in front of them in plain language. So if you were given a Fitbit or something and you want to know, do I wear this Fitbit in the shower? Do I wear it when I exercise? When do I need to take it off? These are going to be things that are buried in instructions or manuals or SOPs somewhere else. Yeah. You can just ask that question. It searches across everything you've been given and it gives you the answer back.

SPEAKER_01 1:23:20

That's awesome. That is awesome. And what is the system called? It's called clear trials. Clear trials. Clear trials. I love it. I I think that's that's a fantastic concept and and idea. So then with your and to your point, the fact that there are, and this is what happens with anybody, right? If you don't, if there's not a solution out there, something like clear trials, right? Then people will make their own communities. Because again, uh, you know, clinical care is similar, but research is very much a community-involved activity. You don't just join a trial and independently go in there and do your thing and go home or whatever. You know, this you have caregivers, you have uh friends, family, whatever, support people, no matter what you're doing in a trial. So if that sense of community, like you're saying, like people found it on Facebook because that's an easy way to set it up. I I yeah, I think that that really does show that people are are interested in this level of help and support.

SPEAKER_02 1:24:15

And they that's right. They're searching for it. And even if it's somebody who's not searching on Facebook, it's somebody like my dad who's searching in the waiting room. He's talking to people, and he what it they they want that sense of community. They want to know that they're not doing this alone, that there are other people who are going through the same experiences as them.

SPEAKER_01 1:24:33

Right. Absolutely, absolutely. No, that's awesome. That's awesome. So then, as your dad has gone through, so he's using is your dad using clear trials you sent forward. Yeah, it is his study. Yeah, we set it up just for him. Yep. That's awesome. That's so cool. So is that like what is hit? I know you're speaking for him at this point, but like what has his experience been with that? Is he does he feel more confident or do I mean has he talked about it?

SPEAKER_02 1:24:56

Yeah, in fact, it's almost given him a sense of preparedness, I think might be the word that he didn't have before. Yeah, and also for my mom, I'll say, you know, the between the two of them now, I think what they what they're able to understand is if you remember, I think when we started this conversation, I think one of the things that was really confusing for them and for me was just the schedule. Like what happens next when, and now they have a much better sense of understanding exactly what's gonna take place. At this point, because the trial is kind of like on cycles, and he's in cycle three now, I think literally is what it's called. Okay. And he understands cycle three at this point, but guess what? In I think two in a month and a half or two more months, he's gonna be in cycle four, and cycle four is gonna be different, and there's gonna be a new set of expectations. When he shows up, it's gonna be a different regimen. Yeah, and so now he's able to look ahead to say, okay, this is what's gonna take place next, and not have to just rely on whatever he's fed just in front of him right now.

SPEAKER_01 1:25:56

Yeah, and that's awesome. That's awesome. I love that. Well, and to your point about not trying to not throw every single question to a coordinator, because as you said, you know, they're all managing seven or ten other studies, and in that study visit, you know, uh, I think you've probably seen this. Like you asked the coordinator a question, and even though they're the coordinator, and coordinators are amazing and they run everything with research, right? Like, but they can't know every answer. No, like again, they're trained on the protocol, they're not necessarily trained on anything outside the protocol, right?

SPEAKER_02 1:26:28

That's right. It's it's it's very much unfair that we put everything that should be known on a coordinator. Um you're right. They do they do it all, and I think they shouldn't have to. And it's also basic things that I've found that my mom will search for, which could be something like is dizziness a side effect? Uh, I don't know if that's exactly. But she searches for a lot of things that like she'll notice that might yeah, because at this point, I don't know if something that's going on with him is could be related to the clinical trial, the the you know, the new drug that he's on, if it's just basic symptoms of his cancer at this point. And she's used that quite a bit. And her uh the the coordinator loves that. I want you to be proactive. And actually, now so one of the great things about clear trials is that the coordinators can see what they're searching, and so the coordinator can say, Hey, if you're dizzy and you're searching for this, let's talk because there could be something going on.

SPEAKER_01 1:27:21

Yeah, I I love that. I that is that's actually really cool. And you said earlier that one of the options people have is to just use chat or some other AI source. I mean, that to me is terrifying, right? Because that's happening every day, and people are using those kind of outlets for answers to real questions. And so some having something like clear trials that sort of is confined to this study information, right? Like they're that's they're not it's not like an extension of chat that they're using in this, right? Like this isn't gonna just give them weird information that you can find on the internet.

SPEAKER_02 1:27:56

Yeah. I mean, I I think one of the things that you'll find. Really quickly, if you use it, is that we're really quick to say what we can't answer, right? If you ask a question that's not answerable within the documents that you've been given, we say you should call your coordinator and ask them this question, or you can message them through the system. But to your point, it's it's a very confined guard-railed system. And unlike ChatGPT, it's going to try to answer your question, even if it's not in the consent form you've been given or the protocol. It'll say, Well, let me go try to. I want to make you happy. I want to give you an answer, even if it's not the right one.

SPEAKER_01 1:28:31

Yes, exactly. Yeah, no, that's uh yeah, that's terrifying that that's gonna be, and again, to you know, when we have situations like this where there are gaps in resources and people are looking for things, then you know, they're gonna go in places that they probably shouldn't go to get answers. And that should not be the case, especially in in research and healthcare spaces. Exactly right. So, so okay, so your dad's been in this trial for a little while now. What is his sort of and yours, I guess, too. What's your sort of take on this? I mean, it not necessarily is it a successful trial or not, but like has it been a good experience overall? Just thinking about the whole the whole situation.

SPEAKER_02 1:29:09

It it definitely has. I think if you were to ask myself, my dad, or my mom right now, who are kind of like his real support system. Are you glad you're in the trial? Do you regret getting in the trial? The answer is most definitely we're glad that we've done it. If anything, I think it's really it's increased his and improved his relationship with everybody else around him who provides his care. He oh yeah, he he has a better relationship. He has a great relationship now with his doctor, with his nurses. Yeah, he sees them and he trusts them even more than he did before. It's I think with a lot of trials, it's bumpy at the beginning getting a participant consented and enrolled because it's it's it's tough. Participants are in a very scary spot, they have a lot of information thrown at them, they're overwhelmed. Once you get past that, there is a lot that's pushed on them, but we have resources to make it a better experience. And I think that's what my dad's seeing now. It's it's it's definitely worthwhile for him. And I know that I think his study ends, it's like it's probably almost six or seven months or something like that. And so it'll be very interesting to see after this, let's say he gets the opportunity to participate in another trial in the future, how that would go. Because I also think that being this is that that this is his first trial ever, and my first trial as a caregiver, yeah. Um, I I I also think that there's kind of a learning curve for everybody, right? And so maybe if we did this again and we were on trial number two, it might be it might be a totally different experience.

SPEAKER_01 1:30:52

Oh, well, sure. And and again, I think that's the I think you know you hear that because it happens on the research side, but uh on the patient side, I've heard that too, is that you know, people who have been in multiple trials, every study is a completely different experience. That's right. It's a completely different, and it's not, I mean, there's obvious reasons why you have different visits and different schedules and whatnot for the study, but I mean your study team changes, it's you know, you just never know. There's so many variables. And to your point, having anything that we can do to help the patient side be a little bit more a little easier, right? Like that's just shouldn't that be our goal? You know what I mean? Like all all of this stuff, it it's such a it seems like such an obvious benefit too. Like if we make not just agreeing to be in a research study, but being in the study itself, like just staying in it, if we make that easier, everybody wins, right? The the we get enrollment numbers, we get the data that we need, we get the the you know, we find out if stuff works or it doesn't faster. Like it just seems like why aren't we putting more resources into the to that side to make that easier on them? That's exactly right.

SPEAKER_02 1:32:03

And and it's the last thing I'll say on this topic is that because people are searching for this like social aspect, like we said, the last thing you want is for somebody to reach out to you and they say, I had a terrible experience in a trial. I didn't have all the resources, and I showed up and I was told when I consented it was going to be a two-hour visit, and I was there for six hours, and they wasted my time and I couldn't find where to park and like all of these things. That's what we don't want to happen. And so absolutely yeah, no, that's great.

SPEAKER_01 1:32:35

That's great. I you know, Brian, I did want to ask you. You've done this now, you you've been the caregiver, right, for for your dad for a clinical trial now for a while. Going through everything you've gone through, I I mean, if there's people listening that are uh whether they're a caregiver for somebody else in a trial or they're thinking about it, maybe somebody in their family or friends are thinking about it. What kind of advice would you give to somebody that's a caregiver on this side of it to, I don't know, encourage or just kind of like, here's here are some of the hurdles I went through. You know what I mean? Oh, I do know what you mean.

SPEAKER_02 1:33:07

I think one of the biggest things that I would say is you're going to have to figure out a way to insert yourself into the the conversation. Um, the the the the caregiver existence right now, like we talked about, I think structurally is kind of ignored. It's very much a participant and a provider or a PI kind of relationship.

SPEAKER_03 1:33:32

Yeah.

SPEAKER_02 1:33:32

But with that being said, PIs and coordinators want that participant to show up. They want that, they don't want them to drop out. And so inserting yourself as the advocate, making sure that you say, hey, I'm the one who drives this person. I'm the one who sits with them every single day at home. When they have questions, I'm the one who helps them answer these. Fighting for yourself to be included in those conversations, I think is critical. And I don't think you actually have to fight that hard because the people want this to work. And so you just have to be, it just has to uh assert yourself as being part of this process. And when you do that, I think that you're going to get a much better experience.

SPEAKER_01 1:34:14

I love that. That is really good advice. And and I appreciate you sharing that for people listening. I think that's a really good takeaway that hopefully people can can take. But yeah, Brian, hey, I really appreciate you coming on the podcast. I appreciate you sharing your story as a caregiver and your and your dad's and and the whole experience. This has been a a great conversation.

SPEAKER_02 1:34:34

Oh well, I thank you for the opportunity, but also thank you for doing this podcast. I think it's really good to make sure that participants and caregivers are not left out of the conversation. So any chance that we can get to put them more at the center of things, I think is is great. So thank you for doing this.

SPEAKER_01 1:34:52

Oh, yeah, of course, of course. Well, you know, can't do it without you. So uh thanks for coming on, and uh yeah, hopefully people will get get a lot out of this. Awesome. Thank you, Justin. Thank you so much for listening. I hope you got something valuable out of these conversations. If you enjoyed the show, please be sure to follow, subscribe, or leave a review on your favorite podcast platform. For more information about our guest today, please check the show notes. I encourage everyone to check out our website at univodashgroup.com to learn more about how we are living into our mission of connecting more patients with research. Thanks again.