Episode 31: Clinical Research With Monae Carpenter and How to Demystify It

Kristen Wynn: Monae, if you would introduce yourself and tell us about your current work here

Monae Carpenter: at the LCI. Sure. So my name is Monae Carpenter. I am now currently the clinical research manager for the Department of Oncology.

It’s with Dell Medical School and LCI. With that partnership and I get to facilitate daily activities for research trials and like kind of manage like the clinic operations. Cool.

Kristen Wynn: Not all of our [00:01:00] listeners necessarily know. Maybe they’ve heard of clinical trials, maybe they’ve heard it in a commercial, they’ve heard it on TV, they’ve heard it in a movie or something, but can you give us a basic description of what clinical trials are and why they’re important?

Monae Carpenter: Yeah, so a clinical trial is basically like a test of some type of medical intervention and clinical just means that it’s done on people. So those tests are done on people and we do it on people so that we can see like the, the true effects of the medicine or the medical intervention. And it’s important that we do these trials because they’re, you know, helping new therapies and prevention techniques come out for these medical conditions.

So.

Kristen Wynn: You do clinical trials in the oncology space with us in the cancer space, right? So everything you’re doing is testing Medicines for cancer. Yes. So how do people facing cancer gain access to clinical trials? [00:02:00]

Monae Carpenter: Well, first I would start with your primary care physician or your oncologist. If you have one, they can get you in touch with someone that’s doing a research study or kind of evaluate if you would be a good research candidate.

Now, if you want to look on your own, you can go to clinicaltrials. gov and there’s, you know, every research study that’s. You know, registered on there and you can just do a search for either the type of cancer that you have or cancer in general and the contact information for those individuals that are running those studies are listed on the website so you can start there as well.

Gotcha.

Kristen Wynn: Okay. This is a big one. So what are some misconceptions?

Monae Carpenter: Oh, there’s so many. So some of the main ones is like, okay, I’m going to be a lab rat. You know, I’m going to get substandard care. I’m going to have to pay for these [00:03:00] treatments or my insurance is going to be lapsed. All those are misconceptions.

You do get the best quality care while you’re on a research study. And I’ve even seen like some patients say that they get better care when they’re on a research study. Because with the doctors that are associated with the study, they monitor you a little bit closer. Um, and you see them on a regular basis.

There’s safety committees that are following you. There’s regulatory bodies that are making sure that. The physicians are doing things ethically sound. So there’s a lot of monitoring that’s going on. And, you know, I did want to say that, you know, in the past there have been some, you know, crazy things happening with research, especially like the Tuskegee trials where they knew that there was a treatment available, but they withheld treatment.

from these individuals for whatever reason. And so there’s more [00:04:00] regulations, more education being done to these people that are conducting research studies. So those types of things hopefully will never happen again. And, you know, it is unfortunate that it did happen in the past, but, you know, there’s associations such as like SOCRA, Society of Clinical Research Associates, also ACRP, Association of.

clinical research professionals. They help educate the research community on like ethical practices so that they can help take care of these participants. Yeah. So awesome.

Kristen Wynn: So the thing that goes through my mind when I think of clinical trials is,

Monae Carpenter: you know, why

Kristen Wynn: would I want to do a clinical trial? Right.

So, because it seems like from my understanding of clinical trials initially before I worked at the LCI and had a better understanding was that. A clinical trial is is a last resort, like there’s nothing else that’s going to work for you. Is that [00:05:00] what are your thoughts around that? Like somebody who’s like, Oh, why would I do a clinical trial?

That sounds terrible. Yeah, like they have a really negative connotation with it. Does it mean that? A physician, an oncologist, is out of options if they’re going to a clinical

Monae Carpenter: trial? Not necessarily. Yeah. Some clinical trials, they do use standard of care options within the the treatment. So, I wouldn’t say it’s like a last resort.

I mean, sometimes it is. Yeah. Like, when we’ve run out of all options, then we could try a clinical trial and you may or may not benefit from it. But, you will be helping further along the advancement of Other therapies that are available to other people. So it’s kind of something that you have to kind of dig deep inside.

It’s like, do I want to help others and help myself at the same time? You know, the, they do have standard of care options that are within research studies. So it’ll be like a more [00:06:00] refined or more, how do you say, like catered to your actual disease type, like while you’re on a study. Gotcha.

Kristen Wynn: So standard of care, just to clear it up for everybody that’s listening, standard of care

Monae Carpenter: is

Kristen Wynn: you still may be receiving similar treatments to those not

Monae Carpenter: in a clinical study.

Yeah, so even if, so standard of care just means like even if you weren’t on a research study, you would still receive this same treatment.

Kristen Wynn: Yeah. Yeah. So how did you end up doing this kind

Monae Carpenter: of work? How did you get here? Oh my. So I graduated with a biochemistry degree, moved to Dallas, and I started working at Fidelity Investments as a 401k specialist.

I was doing that and I was like, should I be here?

And I had a friend of mine who was in Dallas. He worked at the Children’s Medical Center there in Dallas. And he was in pediatric oncology and he was like, why don’t you be a research coordinator? And I was like, okay, what’s [00:07:00] that? Good question.

And so, you know, he was just kind of explaining, you know, kind of like my personality, you know, I like paperwork and tedious things and organizing and facilitating that type of stuff. And so I reached out to a dermatology clinic and I was. Hired as a research coordinator and entry level position, and from there I kind of did some corporate training and quality assurance and I started working from home and then I was like, oh, I hate this

I missed the people. Yeah. So I went back to being a coordinator this time in H I V research, and they did also, they did some other things like diabetes, weight loss, migraines. And then I moved back to Dallas and that was in Austin. So I moved back to Dallas and worked in neurology, specifically multiple [00:08:00] sclerosis as a coordinator.

And then, you know, kind of the needs of my family changed because you’re kind of capped at, you know, what you can do as a coordinator. So I was just. I decided to go into management and I worked in fatty liver and then now I’m in oncology here at LCI. So very cool. Yeah. Yeah. So hopefully my career just keeps progressing, you know, maybe I’m director of clinical research and my strengths are really in operations.

So I can look at things and be like, okay, let’s simplify this process or who do we need to talk to? Let’s get this person involved. That’s kind of where I come in specifically. So that’s how I got here. Nice.

Kristen Wynn: Okay. So tell me more about being a research coordinator. So you gave us a little bit of information about it’s really keeping things organized and the details all together, but can you share, can you tell us a little bit more

Monae Carpenter: about.

Yeah. So a research coordinator is probably like the heartbeat [00:09:00] of research. So they have to schedule the patients, make sure they stay on schedule. Sometimes they collect samples like blood samples and process. They work with the physicians to make sure that they’re documenting what they need to document.

So, you know, they’re keeping them aware of what’s going on. going on with the patient, they’re kind of like the contact person for the sponsors as well. So if the sponsors need data, or they want to know, okay, what happened with this particular patient, they may, you know, send a query is what they call it to the coordinator.

So it’s a lot of administrative work. Yeah. But also there’s patient care as well. Yeah. So you kind of have to have that bedside manner as well. Yeah. So you can’t just be, you know, with blinders on, like I’m going to be in my computer and looking at paperwork all day. You do have to deal with the patients as well and you get to know them and, you know, kind of what’s [00:10:00] going on with them while they’re on the study.

And so you’re just kind of like that go to person for everything. research related to that study. So it’s,

Kristen Wynn: this is cool to me. So. Thinking about this position as you’re patient facing, you’re, you’re the, the person that the company who’s sponsoring the study, you know, you’re their person, you’re the physician’s person.

And so you’re sort of speaking all these different languages, right? And you have all these different hats you’re essentially wearing. And then sometimes you are at your computer, like making sure all the paperwork is done and all the I’s are dotted, right? And all the T’s are crossed. So I love that.

Because I don’t think our audience would necessarily think of, well, it takes somebody wearing many hats sort of going in between all of these people to make this happen. So I think that’s really

Monae Carpenter: cool. Can you tell us a little bit more

Kristen Wynn: about, so you mentioned like the sponsor, right? So there are companies [00:11:00] that.

are creating or organizations that are creating these different drugs or medicines for cancer care specifically or whatever it is. You said you worked in all sorts of things. So multiple sclerosis and migraines, you said, and diabetes. And I mean, the list goes on and on, right? Clinical trials for everything.

So, so can you maybe Give

Monae Carpenter: us a little bit more about

Kristen Wynn: how clinical trials sort of happen, right? It’s not like LCI just decides like, you know what, we’re going to do a clinical trial today, right? Like there’s some

Monae Carpenter: coordination that happens. Yeah, yeah. There’s a lot that goes on behind the scenes. So there is what’s considered preclinical work too, um, that kind of goes.

You know, and we do do that here as well, where let’s say a sponsor, like, wants to develop a drug and so they have to do a lot of preclinical testing, which is just like in a lab, or [00:12:00] they may use animals as well. And they have to have data that supports that this may be effective in humans. Right. And so once they go through that development stage, then, then they can like look for sites and see, okay, well, we want to test this on humans.

This is the preclinical data, you know, they go through the FDA and say, okay, you’re approved to go into clinical trials and then they start the clinical trial process and there’s usually four phases. So, right. Right. The first phase will be the first time it’s being. Yeah. you know, tested in humans. So they look at safety things like, you know, toxicity at what level, you know, does it make the person like so sick that it’s not even worth them doing the treatment.

So, and then they go to an expansion phase where then they use that dose from. Before, and they’re like, okay, this is like an optimal dose. Is it now working, like helping them or helping mitigate the disease? [00:13:00] And then, you know, phase two goes into more safety and efficacy, but there’s like more people on the study.

So we’re getting more and more data as you go through the phases. And finally, you get into post marketing where they’re like looking at different types of groups, different ethnicities, different genders, or they may use an off label disease use or, or something like that, just to double check, okay, will this work for everybody or just this specific group?

So it has to go through all those phases before it actually comes to market. So I will say going back to. Like what I do or how I got here, there’s so many things that you could do in research, especially with data, because research is just all about the data. And, you know, it’s about the individuals as well, but, you know, if we don’t have the data to support, okay, this does work, it is safe and effective, then, you know, it’s no sense in doing the research study.

Yeah, absolutely.

Kristen Wynn: And just to make [00:14:00] it clear for our audience as well, this is not something that happens in like.

Monae Carpenter: Oh, no. Years, years, years. Yeah.

Kristen Wynn: Yeah. I was listening to somebody.

Monae Carpenter: A while back

Kristen Wynn: talk about how some drug that he had been working on had been in clinical trials for like 20 years, right? Yeah,

Monae Carpenter: yeah, I worked on the Camilla trial, which is a waste weight loss drug.

And that was 2016. And just now they, you know, said, okay, well, we’re gonna, you know, pull it off of the shelf because it’s not working. And so they’ve been testing it all these years since 2016. And, you know, it’s 20. Okay. Yeah. 23 now. Yeah. So it’s like, Oh, it’s like I worked on that. Yeah. Study.

Kristen Wynn: Yeah. So this is not an overnight thing, right?

This is patient by patient. This is phase by phase, right? Yeah. So, yeah, I think, you know, we’ve talked to bench researchers on this. On this translational researchers, right? And so I think, you know, the, the theme that we keep hearing over and [00:15:00] over again is like, nothing is overnight, right? This takes time.

It takes patience. It takes failure and then trying it again. And so I also think it takes somebody really special to do this work and stay with it and be there for patients. Right. Yeah. And sort of have that bedside manner. But also be data focused too and making sure that

Monae Carpenter: everything’s safe. You want to make sure that the data is quality.

You know, for example, we have what’s called a PK day pharmacokinetic where the subject may take the drug in the morning and then we have like periodic tests. of their blood, you know, throughout the day. And so if you miss a time point or you draw them wrong or something like that, it doesn’t make a really good experience for the patient.

And then also you’ve now messed up the data where it’s not usable. And so you, you kind of have to be on your P’s [00:16:00] and Q’s and, you know, know what you’re doing, ask questions or, or whatever you need to do, stay organized. So that you could meet those time points and get quality data. Yeah, absolutely. Can you tell me a little bit

Kristen Wynn: about the team that you’re building?

So, you know, to think that you could do this by yourself is crazy. So can you tell me the sort of, and I know that you’re in the middle of kind of building your team now. So tell me about, you have a new hire that she’s come on. But can you tell us about, Like the team that you’re building, what, what those roles would be, how they’re helping you

Monae Carpenter: make all of this happen.

Of course. So the new hire that you’ve seen is our research nurse. So she’s going to be helping with patient care things. She may help like kind of get us organized with, you know, worksheets to make sure that our study flow is good, reviewing adverse events and adverse events, or just. reactions that the patients have to the drug [00:17:00] or, or reactions in general.

And so she’s going to be doing that. And then we also just hired a project manager. He starts on Monday. Yeah. So very excited about that. So he’s going to be helping like just kind of move everything, move everything along. So there’s a lot of moving parts, especially with Seton and UT kind of collaborating in the research department.

And so getting studies started. Making sure our regulatory documents are where they need to be. Once we get patients on a study, he would be checking in to make sure, okay, did this patient complete? Did they do all of their visits? Kind of like a quality assurance check. And we also have a senior research coordinator.

The research coordinator would kind of be doing those things. So they would be primarily seeing the patient and entering data. And then we also have a research associate, which is kind of just like… An assistant to the coordinator. Cool.

Kristen Wynn: Yeah. [00:18:00] Okay. Do the patients that sign on to clinical trials, would they see all of you?

Do they have one point person? Like what is

Monae Carpenter: their interaction with your team? Yeah. So they, their point person would be the coordinator. There may be times where we would pull in the research nurse to see the patient. Like if there’s some patient education thing that needs to happen, uh, or, you know, it’s a research nurse.

needs to assist the doctor in some way, then they may see the research nurse, but primarily they’ll be working with the coordinator. Yeah. And

Kristen Wynn: so that brings another question in my head too, or maybe just for you to talk more on. Yeah. So you’re also interacting with our physicians in the clinic to say, you know, Hey, Dr.

Capasso, Hey, you know, Dr. Ong, right? Like how, how does that work? Do they? How does this come about? Right? So we have a pretty small clinic right now, [00:19:00] and I assume that, but you can tell me whether this is correct, you would do a clinical trial within sort of the specific areas that they work in. So GI cancers, potentially breast cancers, potentially blood cancers, right?

Like the cancer subspecialties that we cover. Right. When you are sort of seeking clinical trials, I would assume you bring in our oncologists to say

Monae Carpenter: Yes, to be part of that decision making, right? They would be brought in to kind of talk to the sponsor about what they can and can’t do. Okay. Or what they would be interested in doing.

Uh huh, okay. Because they kind of have to have an interest in the study and also they have to assess Assess whether or not that study is scientifically sound like, is it safe for the patient? Mm-hmm. , or do they think that it would benefit the patient? Mm-hmm. . Um, because they would be the ones kind of referring the patient to the study.

Right? So if there’s a better standard of care, [00:20:00] then we’re not gonna enroll on this study. Right. You know, because we want what’s. Yeah. Okay. But, you know, if a study could kind of increase their quality of life or, you know, something like that, then we could consider a research study. Gotcha.

Kristen Wynn: Okay. How does that process happen then?

We

Monae Carpenter: kind of monitor the patients that do come in to see like what type of cancer types that our patient population has. And then a sponsor may contact us or we may reach out to a sponsor and say, Hey, we’ve got, you know, all these pancreatic patients. Is there a study available for them that we could be a part of?

And then, you know, the sponsor may say, Oh yeah, we do have this study that we’re looking for sites, and then we have to go through a whole contract and budgeting process, um, and we have to be selected as a site and then we kind of get the ball rolling there and that’s [00:21:00] kind of where our project manager will kind of, you know, step in and make sure we have all the.

Gotcha.

Kristen Wynn: Gotcha. The other question that I had in my head was, so my small understanding of clinical trials is that the patient that would enroll has to meet certain requirements, right? So

Monae Carpenter: it may be, you know,

Kristen Wynn: Certain comorbidities might get in the way, right? Like, is that, can, I guess, can I have you talk more about how it’s decided who gets to enroll in these

Monae Carpenter: studies?

Yeah. So there’s a protocol for every study. So in the protocol, they have what’s. called inclusion and exclusion criteria. And so in order to make sure that the data is sound that we get from the study, those people that enroll have to meet the inclusion exclusion criteria. [00:22:00] So they, you know, are 18 years and older, or they have pancreatic cancer, or they have this certain lab value, those types of things.

need to be met before they enroll in the study and really all that does is just make sure that Like they the drug may be effective on the cancer type that they have, you know If we just kind of let anybody Be on the study, you know, it may or may not be You know effective for them right or worth their time even being on the study.

So that’s why they have that shirt criterion. All right.

Kristen Wynn: I’m going to skip to the last question then. What words of wisdom do you have for our listeners that are future health care providers and health scientists?

Monae Carpenter: I would say trust the process. Everybody’s path is different. Find something that kind of celebrates your personality and the things that you enjoy doing so that when you do actually go to work doing these [00:23:00] things, it doesn’t feel like work.

It feels like, okay, I’ve, you know, doing my part or, you know, something that I’m excited about doing, you know. Is there anything that I…

Kristen Wynn: should have asked you, or is there anything that you think this audience should know about clinical research, clinical trials, these concepts that we’ve been talking

Monae Carpenter: about?

Yeah, I did want to just kind of emphasize the fact that, um, you know, We’ve come a long way with research in general, you know, we’re more patient focused, you know, I, I did say that, you know, research is about the data, uh, it is, but, you know, that data wouldn’t be possible without taking care of the patient, you know, that’s how you produce it.

Quality data as you take care of the patient and you document, document, document. So that saying that if it’s not documented, it’s like it [00:24:00] never happened, that kind of thing always has to be in the back of your mind because you deal with a lot of different things on a daily basis. And so you may not remember.

What happened like three weeks ago, unless you documented it and then somebody picking up where you left off may not know what happened unless you document it and it, you know, kind of does a disservice to the patient and does a disservice to, you know, the sponsor as well trying to collect this data if we don’t know what happened.

Yeah, so

Kristen Wynn: absolutely. Okay. Anything else? I’ve been doing a lot of work in. Equity, like health equity by doing a lot of work. It means I’ve been to a few conferences lately. Okay. And I’m working with our DEI office on some programming for undergrads. So the idea of equity comes up a lot in my world right now.

And it

Monae Carpenter: should, right? I mean,

Kristen Wynn: that’s [00:25:00] it goes hand in hand, equitable cancer care. I think the things that keep popping up for me are working with I’ve been to, I was at a conference recently where. There were patients talking about feeling like they didn’t have access to clinical trials, right? Like, it wasn’t suggested by their physician.

They weren’t asked about it. It wasn’t sort of brought to their attention. Yeah. But some of the, the surveys actually showed that had you asked… that patient about taking part in a clinical trial, they would have been interested. They just didn’t know it was a thing. So I think even just the concept of clinical trials on this podcast to me is like, if you learn nothing else, right?

Like this is an option. Like this is something that exists for you and your family and, and. Maybe even to empower people to ask about it, right?

Monae Carpenter: If your physician isn’t bringing out on clinical trials that [00:26:00] go, that’s right. You know, that’s what I would do. If I was looking for a research trial or being part of a research trial, I’m asking your physician or your oncologist.

Um, you know, specifically it’s like, Hey, can I be on a research study, you know, and, and they can kind of point you in the right direction too. Gotcha. Yeah. But having

Kristen Wynn: those in house. So it’s ideal for someone, a physician on our team to be able to present that to a patient and say, Hey, we are a part of this, right.

Instead of, you know, you sort of taking it to a physician, which, which also works

Monae Carpenter: and saying, I really want to be a

Kristen Wynn: part of this trial. And then they might have to direct you. To somewhere else. Yeah. So the, so ideally, whatever cancer center you’re going to can kind of maybe do it right there if you want to stay with your doctor.

Right? So that’s the importance of our cancer center. It’s a new cancer center,

Monae Carpenter: right? And we’re expanding. We’re starting new studies so that we’ve looked at the patient [00:27:00] population and we’ve We have to be very selective with the studies that we start because we’re so small. Yeah. But, you know, the studies that we have selected, we think that we can accrue patients because we’ve already looked at our patient population and these are the types of patients that would benefit from this study.

Gotcha.

Kristen Wynn: So as you all are making decisions about what, what trials to take part in, you’re looking at your patients, you’re looking at their needs.

Monae Carpenter: Mm hmm. Yeah, absolutely. And then, you know, right along the lines of the equity inclusion vein, they’re also offering research studies to people of color as well has been a challenge because of things that have happened in the past, but there’s a stigma there.

Yeah, there is a stigma, you know, that if you’re a person of color and you’re on a research study, you may, you know. Not receive the best treatment or the best care or, you know, something like that. So I think, you know, kind of striving towards having like [00:28:00] other physicians, like maybe look like you or, or doctors or nurses that maybe look like you have a coordinator look like you, you know, that kind of helps kind of that, that stigma that you said helps.

people feel a little bit more comfortable. Um, and so I love T’s stance on diversity, equity, inclusion. They put it in the job description. You know, this is our goal. You know, I even put, I put in my signature line for my email too, that we’re, you know, closing the gaps, you know, between us. And so that was important to me because, you know, being a person of color, it is kind of hard sometimes to have your voice heard.

And, you know, so like kind of getting in those spaces, you know, I’m kind of like a research subject, you know, kind of breaking into those spaces and, you know, saying, Hey, you know, I do research too and, and it’s okay.

Kristen Wynn: [00:29:00] Yeah, and that’s super important for our listeners to know that too, right? Like everything you’re talking about about looking like our patients representing our community, right?

That’s insanely important. I mean, the trust factor has to be there. Yes. And I think. Just showing others that yes, you can be in these spaces, right? And being a role model for others is really important. And, I mean, to kind of go full circle then, right? Like, your data is not going to be complete unless you have…

you know, data about everybody, right? So, so, you know, it goes back to everything is better when you include everybody, right? Like you’re, you’re, you know, preparing medicine for cancer gets better. Like that process gets better. More people are served, right?

Monae Carpenter: So, so reaching out to the community is, is one of the things on my list.

So, you [00:30:00] know, when we start talking about like marketing the clinic, you know, reaching out to different diverse communities and say, Hey, you know, we do patient centered cancer care here. We use the calm care model and, you know. Come and check us out, you know, hopefully we get like some prevention screening type program going.

And that would kind of help kind of let people know that, okay, we’re out here, we’re here to help, you know, we’re available for

Kristen Wynn: that. Yeah. Yeah. So thank you. Thanks for making the time and you do and where you hope to go and we’ll be. We’ll be excitedly watching. I’ll have to catch up with you. Maybe, you know,

Monae Carpenter: maybe in a few years and see how things are going.

Kristen Wynn: Exactly, right? Like, how

Monae Carpenter: are things working out, right? Yeah, before and after. That’s right. That’s

Kristen Wynn: right. Yes. Awesome. If you have questions for us or an [00:31:00] idea about a future episode, please email us at LivestrongCancerInstitutes at DelMed. dot u texas dot edu. To find out more about the Livestrong Cancer Institutes, please visit delmed.

Please also follow our department chair, Dr. Gail Eckhart, on Twitter at sGailEckhardt. Eckhardt is spelled E C K H A R D T. This is Kristen Wynn with the Livestrong Cancer Institute and Cancer Uncovered, an education and empowerment podcast challenging you to keep asking questions and Stay curious. Thank you for listening and learning with us.

We’ll see you next month.