Announcer:
0:00
Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts Hosted by cardiologist and top medical researcher, Dr Michael Koren.
Dr. Michael Koren:
0:11
Hello, I'm Dr Michael Koren, the executive editor of MedEvidence, and one of the things I actually like about my job is the fact that I get to meet new friends and get to know them and understand their experiences. As past president of the Academy of Physicians and Clinical Research, I've had the opportunity to meet people over the country and all over the world both physicians and coordinators and other people that touch the clinical research space and it's interesting to see different pathways getting involved. So I want to introduce two friends. They're almost old friends. We've known each other for 10 minutes now, so you guys were brave enough to get in touch with us to do a podcast, so why don't you tell the audience your names, where you're located and a minute or two about your background?
Alexandria Clark:
1:01
My name is Alexandria Clark, so my background is in medical engineering. After that, I got involved in the clinical research space in allergy, asthma and immunology, where I met Anna here and we recently started in 2021. So that's new in the big scheme of things. A clinical research site that partners with private.
Anna Fehr:
1:26
I'm Anna Fehr. I'm a nurse by trade and been in research for going on 15 years now and, like Alexandra said, that's how we met and decided to come up with our company.
Dr. Michael Koren:
1:37
So you guys just started the site in PC1. You're PC1. Are you? familiar with that expression.
Alexandria Clark:
1:50
No
Dr. Michael Koren:
1:50
Post -COVID-1
Alexandria Clark:
1:50
Oh okay, yeah, that's funny.
Dr. Michael Koren:
1:58
Yeah, the whole clinical research environment completely changed prior to COVID and then after COVID. And for some sites, like the sites that I'm involved with here in Northeast Florida, we were very involved in the COVID studies and other vaccine studies that became a focus. But there was a huge shakeout in sites that weren't doing those studies because, as you probably know, when the pandemic hit, a lot of sites were closed down that weren't doing those vaccine studies or treatment studies for COVID and unfortunately for small companies, that can be devastating. You may not have the wherewithal to keep your business going for a prolonged period of time. So you folks took the plunge right after COVID. So kudos for that. That was very brave and it sounds like you've been rewarded by growing your company, which is tremendous, and it also your focus is in an area that's a big need in clinical research.
Dr. Michael Koren:
2:45
So asthma studies are tough, it's tough to find them, but it's really important. Asthma is a disease that's growing, that affects people of all ages, and there's some interesting new therapeutics that are being evaluated. So finding the right patients for those studies is really important. Immunology is, of course, a really important area. Again, sometimes very difficult to find patients, and then you mentioned you're involved in gastroenterology, which is another area where there's a lot of innovation going on. We've done several recent podcasts on some of the innovations in that space. So again, kudos for getting involved in some really cutting-edge stuff. So you folks, you told me that you have a site in Scottsdale, arizona, and a site in Napa, california, so tell us a little bit about the patient population. They seem different to me but, again, I grew up on Staten Island, so I'm pretty isolated in terms of my worldview.
Alexandria Clark:
3:40
I'd actually say they're pretty similar. So they're both areas that have a lot of high growth and high financial persons, retirees, the families that travel to Napa for the wine country, the people who travel to Scottsdale for the parties. Scottsdale's really been up and coming in that area, and then we also are right next to Phoenix, which is known for having a huge, robust population of different minorities, different financial backgrounds. It's really a melting pot of a lot. And then right around that main downtown Napa you have all your farmlands, a huge Hispanic population, and so we really get the best of both worlds of having those altruistic patients who want to participate, who maybe don't need Arizona it financially, the support from clinical California, and then also the patient populations who need that financial support from clinical research, of getting to try out new, innovative medications that they may not be able to afford otherwise Interesting.
Dr. Michael Koren:
4:46
Now you folks mentioned you've grown your company to 15 employees Congratulations on that and you've been able to engage a number of physicians. That's hard. Physicians are a tough breed, I hear, and of course, speaking as a cardiologist, but what was your secret? How did you engage those docs?
Anna Fehr:
5:04
Well, we honestly got really lucky Some of our drug reps and some of the sponsors that we work for. We let them know that we help raise new PIs and partnering them with our experienced PIs to start in clinical trials. And if they ever know anybody that's interested or somebody comes to mind, just think of us and that's actually happened quite a few times where a sponsor or a drug rep would reach out to a provider and say, hey, I know these girls, I know you wanted to get into research, but you don't know how they can help you and support you. And that first year raising up a new principal investigator, it's a lot of hand-holding, it's's a lot of patience, it's a lot of one study, slow moving at a time. But that's how you do it, you do it right.
Anna Fehr:
5:47
And we're willing to do that. A lot of other companies aren't. They want to just get a PI in there, slam them with studies and then move on to the next thing. We're in this for the long game.
Anna Fehr:
6:00
We're not in this for the short game.
Dr. Michael Koren:
6:02
Sure sure, and tell me a little bit more about the physician profile. Are they in small practices, large practices, solo practices? Male female, etc.
Anna Fehr:
6:14
Yeah, we're looking for primary principal investigators that
Anna Fehr:
6:18
own their own practice or are part of a small group and then as a group we'll agree to participate in trials Male, female doesn't matter, age range doesn't matter, patient population doesn't matter. We'll try. For if they're interested in research and that's a passion that they want to bring into their practice, we'll give it a go.
Dr. Michael Koren:
6:42
And how do you communicate the value proposition to the potential patients? Scottsdale and
Alexandria Clark:
7:01
So, a lot of that comes down to making sure that we have a really good conversation with our PI's to start. What do their patients seem to be motivated by? A doctor who is really involved in clinical research and wants to give back to his community usually knows, hey, my patient profiles they're really going to care about being a part of the biggest, newest thing these ones are really going to care about. We can't afford our medications or this is an ultra rare disease and we're just so frustrated with lack of treatment. Some of them know that their patients really like handholding and are going to be motivated by that 24-7 on-call nurse. Ours is very involved even text them about things that don't have to do with the study, just to make them feel comfortable and make them feel like they have somebody in the healthcare community that has their back and will advocate for them and get them in touch with the right people. And I think that having that going into contacting the patients is the most important part, and so that's where the physicians really matter on knowing your patient population and helping us when it comes to that.
Dr. Michael Koren:
7:55
Yeah, what I found the secret over the years is having people. It's great if it's an investigator sometimes the investigators have these skills, sometimes they do not but an investigator that can have a conversation with a patient and then articulate the potential value proposition to that patient. So, for example, in some cases it's resources. In Napa are places where people are relatively well-resourced, but you mentioned other parts of your environment where people may not have great health insurance or may not have access to some of the testing that's done to establish diagnoses. So getting access to resources is important to people. For some people it's getting stipends. Most of the studies that we do do provide a stipend for the patient and that can be a wonderful gift.
Dr. Michael Koren:
8:46
People that maybe struggle a little bit to have money for their Christmas gifts can be part of a research program and then be able to earn that fee and, in turn, use it to buy gifts for their family and friends. Another example, but probably the biggest thing, is people want knowledge and engagement , and so you two strike me as people that are very good at educating and fulfilling that concept and also the whole involvement with patients, feeling they're part of a community. So you're part of a small community in your respective markets and then we're part of a somewhat larger but not a huge community of clinical research professionals who are sharing our experiences and ultimately creating better medications, because of the fact that this information ultimately gets into databases and it helps us decide what treatment works, what doesn't work, how we move science forward and ultimately get products in the market. So people sense that and being engaged, educated and part of a community is a huge driver for a lot of patients.
Anna Fehr:
9:54
Absolutely, yeah. Another point that we'd like to make about working with our patients is we're a little bit different than some of those larger networks you know, hospitals and whatnot that do research. We have flexible scheduling right. We can offer those weekends, late afternoons to work around that patient schedule where most patients Doctors' offices can't do that and most research places can't do that. The other things like she mentioned having the 24-hour on-call nurse service and having your PI be your best recruiter for patients in a study Absolutely.
Dr. Michael Koren:
10:35
Yeah Well, those are all really important concepts. Sometimes we talk about research as a care option. You always have to be a little bit careful about that, because research by definition is elective and not specifically care. But there are very major gaps in current medical treatment in our medical system. That research fills. There's no question about that. So just being able to talk with somebody, who has medical knowledge in an unpressured atmosphere is something patients don't get anymore.
Alexandria Clark:
11:10
And we like to refer to it as a resource is we're here as your resource. Even if you don't end up using research, we can at least get you over to the right person. So if we call to talk to you about research and you're like I don't really want to do this, but I do need to talk to a nurse for X, y and Z, let's forward you over to the right department. We at least have that inside connection so you're not waiting on calls for hours, and so we like to just be an extension of resources for that physician and for the patients.
Dr. Michael Koren:
11:38
Yeah. So now the other question and I'll make this my last major question which is you work in areas that are sometimes really hard to find qualified I∓mpE patients For those people that aren't that familiar with research. Each of our projects has very specific inclusion and exclusion criteria. That limits the number of people that we can approach, and if it's a relatively uncommon disease, it's even more difficult. So tell us your secrets. How have you been able to be successful in that environment?
Anna Fehr:
12:08
Oh man, we pre-screen like crazy. We really do. It probably takes the majority of our time to have conversations with patients and obviously this is no charge and most of the time it's no charge to the sponsor either. It's part of research where we go in and we do a full, deep dive into medical records and if it doesn't match up perfectly with this criteria but the patient really wants to be a part of something, then we we hang on to their info and as long as they agree to it, we'll wait to find that next study for them and hope that we can find something closer. Or we give that information back to the principal investigator and say, hey, she's missing these preliminary tests that guarantee her diagnosis that would allow her in. Is there any way we could work this out? And we've been really lucky. We've had some great studies where they do a lot of preliminary testing as part of the screening visit to help with that issue as .
Alexandria Clark:
13:08
I think we're on a handful of advocacy boards on the sponsor side for some of these rare diseases on how do we make a protocol and make I&Eamp; that not only meets the FDA's needs and the study's needs but it's realistic to what people are actually doing in regards to diagnostic and treatment criteria. And having those relationships with those patients in those rare disease fields helps us know what's actually going on. Why are studies not able to enroll patients? Where's that gap? And then going back to the sponsor and communicating it. And we've actually seen I&E criteria change with some of these things that we've noticed and reported back.
Dr. Michael Koren:
13:45
So just for the audience that is not initiated. I&e is inclusion and exclusion criteria. That's all right. That's. My job as an editor is make sure everybody's on the same page, but I just want to clarify that. So I would summarize that your secret is persistence and charm. I think you guys exude that, and thank you for being part of the Clinical Research Enterprise. The best of luck to you at your site and we'll definitely let people know that you're out there and the sponsors should know about the good work that you're doing. So thank you very much for being part of MedEvidence and I'll give you any final word. The guests always get the final word.
Alexandria Clark:
14:25
I guess thank you very much for being part of MedEvidence and I guess. Thank you so much for having us a part of this, and we hope that any patients who are listening want to learn more about clinical research. Even if there isn't a specific study you want to be in now, reach out to your local research centers and just learn about the process, because knowledge really is key here.
Dr. Michael Koren:
14:43
That's a great final word. We'll leave it at that. Thank you for joining us and being part of the MedEvidence family.
Anna Fehr:
14:49
Thank you.
Announcer:
14:50
Thanks for joining the MedEvidence podcast. To learn more, head over to MedEvidencecom or subscribe to our podcast on your favorite podcast platform.
