Closing The Gap: Addressing The Investigator Shortage In Clinical Trials

Alyssa Boschen, Regional Site Director at IMA Clinical Research, discusses the growing challenge of investigator shortages and how it impacts clinical research studies. Alyssa highlights how advanced practice providers (APPs), such as physician assistants and nurse practitioners, are stepping in to help bridge the gap as investigators. Discover how these medical professionals support research site operations and find new career opportunities in clinical research.

Transcript

Jimmy Bechtel: 0:02

Welcome to SCRS Talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. Today, I'm joined by Alyssa Boschen, the Regional Site Director in the Southwest for IMA Clinical Research, and she's here to talk with us a little bit about the gaps and challenges we face with the investigator shortage in clinical research. Alyssa, awesome to have you. Really excited to talk about this topic because I know it's been one that we've had a lot of discussion around within the SCRS community at our summits and just in the industry in general, particularly coming out of the pandemic. But before we jump into our questions, if you wouldn't mind, I'd love to learn a little bit more about you and a little bit more about IMA Clinical Research.

Alyssa Boschen: 0:57

Yeah, absolutely. Thank you for having me. It's a pleasure to be here. As you said, my name is Alyssa Boschen. I'm the Southwest Regional Director for IMA Clinical Research. IMA Clinical Research is a site network of over 20 different clinical research sites throughout the United States specializing in a variety of different indications. We have some sites that focus in psychiatry studies, such as depression, bipolar, schizophrenia, anxiety, some in the neurology space some that actually do vaccine work, metabolic work NASH, MASH, those types of things, women's health, among many others. We have both standalone and embedded research site models, although the sites that I work with primarily in the Southwest are standalone research facilities. As the regional director, I'm responsible for overseeing the overall site operations in Phoenix, Las Vegas, San Antonio, and Albuquerque regions. I am actually based out of Phoenix though. As a physician assistant by training, I have been involved in running clinical trials from the site side of things since about 2012. I have worn all hats over the years. As many of us do in clinical research that includes everything from being a research assistant to coordinator, lab technician, investigator, site director, and more recently, regional director. And since 2017, I've been on over 140 or so clinical research trials as an investigator. And I continue to remain on the site operations side of the industry because, you know, that's what's really very interesting to me. I'm very passionate about working with the patients that we work with, as well as seeing clinical medicine develop.

Jimmy Bechtel: 2:44

Thanks, Alyssa. That's great. It's important to learn a little bit about you, so thank you for sharing. Alyssa, if you wouldn't mind starting us out kind of jumping in on the baseline here a little bit more elaboration on what the situation is with investigator shortages in clinical research and as a large network of sites, I'm sure you are not immune to this shortage and are seeing not only direct effects, but indirect effects that this is having on your site and the industry as a whole. And why then is it becoming more challenging, I guess, to find these physicians that are actually willing or providers rather, maybe not even just physicians, but providers willing to participate in research as PIs?

Alyssa Boschen: 3:28

Yeah, absolutely. And I think that's a really important topic for us to consider, because it's really going to shape the way clinical trials can move forward and medicine can advance you know, we have been seeing more and more and it's not just specific to the clinical trial industry. Right? There's been a lot of data that comes out that's supporting that. There's just a decrease of physicians in the, in the workforce in general, which is going to then consequently impact clinical research, having fewer investigators, physicians available to participate in clinical research and ultimately that would negatively impact the volume and quality of clinical trials that we can run. But, I mean, it's beyond just that surface blanket statement. It's also we've been seeing a huge shift in medical practice over the years where we're getting a lot further away from the standalone medical practices where these physicians will have their own medical practice. And they might at some point, several years down the line, begin doing clinical research trials with their experience in that medical practice. We are seeing more and more that there's a shift overall in medical practice to these larger groups. And, you know, I'm not sure if you've experienced that, but I know I have personally experienced that there's been several physicians that I've had that have actually closed down shop and have actually gone to be a part of larger physician networks. And these larger networks tend to be focused on the end line and getting as many patients in as they can. So we're getting a lot of medical practice changing in that sense. And these bigger groups oftentimes don't have the flexibility to say, Hey, let's try this clinical research side of things and the physicians will end up getting caught up in doing all things medical practice and they don't end up focusing so much on clinical research or branching out into these kind of niche areas of medicine. You know, I think it goes beyond that as well. You were having a lot of these experienced clinical investigators that are retiring. They're retiring and coming out of clinical research and we're just not seeing as many people because of the reasons I cited before jumping in, and gaining that experience over time. So, you know, we've seen a lot of data that even people that are willing to try clinical research studies and being principal investigators on these studies they may not want to continue in research. There's about 66 percent of investigators that fill out a 1572 end up filling out a 2nd 1572, which implies that they're doing a 2nd clinical research trial. So, part of that is, there's a lack of medical providers overall in the country and a lack of people that are staying in research and experienced in research and are joining it right when they come out of school.

Jimmy Bechtel: 6:22

That's great. Alyssa, a lot of great points in there. And I would add research is a tough thing, right? It's a tough area of medicine. And I don't think we do a good job of helping people understand, which we don't need to get into today, but how it affects the bottom line, right? The financial end all of research, because for some it can be an enhancement, right? It can be a profitable venture beyond clinical practice because you know, it's extra work for these providers. Like you said, they're oftentimes engaged in their own clinical care, right? They're treating patients in their own clinics. And they do research in addition to that, which is in a lot of cases, right? I get, you know, the other side of the coin is physicians, providers that are purely researchers. They're doing study after study, but for a lot of them, it's tough to take on that additional burden if we're not able to, as you said, make them understand how that affects their bottom line, potentially positively. Now it doesn't affect everyone's positively. I think if you were able to be a millionaire off of clinical trials, as an investigator, everyone would be doing it, but it's a lot of work and not everyone is successful at it. And I think it's really important for us to understand kind of culminating what you said there, understand why it's not and what we can do to kind of help those potential investigators understand what that means.

Alyssa Boschen: 7:44

Yeah, absolutely. And, you know, there is a lot of work, like you said, and I think it can be quite daunting, especially people that are new to the industry, and they've always wanted to do clinical trials, and they have an opportunity, they fill out that 1572, and then they get into it, and they realize how much additional work goes into running these studies. But like you said, it can positively impact a business's bottom line but you do need to stay focused on it, right? If we get caught up too much in our clinical practice and we put clinical research too much on the side, we end up not really being able to make it worth it when you look at the bottom line at the end of the day. So, that absolutely can have an impact on it, but there's a lot that can be said for you know, we need to find people that are interested in putting in that time and effort up front and with the understanding that, yes, ultimately, it absolutely can positively impact the bottom line, but you definitely need to stick with it and stick it out.

Jimmy Bechtel: 8:39

Yeah, no kidding. Well, and some of those other people, right? Some of those other roles here getting creative and thinking about solutions. Is the interest in physicians assistants, right? PAs and NPs, nurse practitioners working in clinical trials and their actual involvement, right? We know there's opportunity there. So how are these roles potentially uniquely positioned to address that shortage of investigators? Is there anything we can do there? I know the oncology space calls them APPs, right? Advanced practice providers. So how do we leverage that aspect?

Alyssa Boschen: 9:11

Yeah, absolutely. So, as a PA by training myself, I've spent a lot of years working in what I would suggest would be a fantastic way to continue to broaden the clinical trial ability of a lot of physicians and a lot of medical practices out there by utilizing PAs and MPs. So basically, there's going to be, or there is a physician shortage and, just as in medical practice, in clinical research, PAs and MPs can fill in a similar gap, right? They can help support the clinical research team by making sure that we're providing ongoing oversight as an investigator to the clinical trials. We can actually have the PAs and MPs do a lot of the evaluations. A lot of the evaluations of if a patient is eligible, if they're experiencing an adverse event or a serious adverse event, and how to document that appropriately and determine the relatedness of the IP related to the adverse event you know, all the way to prescribing any of the medications that are needed in the trial and evaluating labs, vital signs, seeing the patients, conducting physical exams. You know, we're trained medically to do all of these things in our education and our background and we can absolutely step in and fill in as an investigator in these clinical trials to help support the research team and help support these practices, stay involved in clinical research. I would say that NPs and PAs are also very much, in our training, we're very much aimed at working in a team environment in healthcare, and, we understand that there's a lot of different elements that go into treating a patient. It's not just about that patient that's sitting across from you. It's also about all of the different people that we're going to need to communicate about a variety of different things to make sure that that patient's care is overseen properly. It's the same thing in clinical research, and, you know, they can collaborate with a team of researchers to make sure that that patient and that participant in the clinical trial is overseen properly according to you know, ICH GCP guidelines and FDA guidelines. We can absolutely stick to those and and be able to help support the team in doing that. And just like we would in clinical practice, we would be able to support the research team as an investigator and help make sure that everybody has proper oversight while in a clinical trial.

Jimmy Bechtel: 11:34

Exactly. There's ways that this can be done. And I love your examples that you gave of, you know, we don't have to think of it as all or nothing, right? They don't have to be the investigator and oversee the entire trial. There are things that they are licensed to be able to do. Absolutely. And arguably depending on the complication of the trial and the investigative product and some of the processes, things that they are not able to do, but let's leverage this availability, this growing and very valuable profession in medicine to fill a gap in for clinical research. So again, great example and great potential use of some very skilled and worthwhile considerations and workforce.

Alyssa Boschen: 12:17

Yeah, absolutely. And the other thing, too, is one of the hallmarks, I would say, of PAs and MPs is they very much have a very patient centered approach to care, and they build very well these rapport with patients that actually can end up Being a positive impact in clinical trials as well, right? If you have a positive rapport with an investigator in a clinical trial you know, we tend to see increase in retention rates in the clinical trials and people that want to stay and continue to participate in the trials that we do. So, I think that they can add on to that having that increased availability for the patients and an increased interaction with them and make sure that the patients have all of the educational materials they need to participate and really feel like they're a member of their own research team. So, I think that nurse practitioners and PAs are really uniquely qualified to do all of these things and to partner on these research teams and help fill a gap for sure.

Jimmy Bechtel: 13:16

That's excellent. Yeah, thanks again for emphasizing that. I do think it's a really important consideration that we might need to look at as a research site owner or manager or director. And how we can utilize that workforce. So I want to begin to wrap us up here, Alyssa, with with another question, how can sites then and sponsors work together to advocate for those advanced practitioners as qualified research investigators? What can be done in partnership in concert with each other to move that portion of the needle forward and use that potential workforce to fill this gap?

Alyssa Boschen: 13:51

Yeah, absolutely. I mean, I think we start with, you know, just having the research industry as a whole. I would challenge the whole research industry site sponsors everyone to be open to evaluating PAs and NPs as investigators. They have the education and background to help support that role. So being open to to evaluating them. I think the other part of it is, I would love to see educational programs that partner with sponsors and sites, you know, improve clinical trial engagement during training as well. I think that that would be a really interesting way to start to partner and bridge the gap of investigator shortages is, you know, hey, let's work with the different educational programs that are out there and start at the education level that, hey, I understand it's very interesting to go into all these different specialties that we can specialize in, but don't forget about clinical research, right? Clinical research can be part of the specialty that everybody goes into or family practice, whatever it is That being an avenue for PAs and NPs to go into and really building the overall interest in bringing PAs and NPs on board, but also improving the overall training that goes on at different schools. I think that that would be really important. And if there's ever an opportunity for school programs that have these programs to partner with sponsors or even sites, you know, sites that are willing to bring them on and have them shadow for some time to see what it's like to work in the research field. I think it would really improve their involvement because, you would get the exposure. I think research really allows for a very good work life balance. And I think it would really appeal to a lot of people if they knew exactly what went into it. And they saw what it's like. There's there's a level of excitement and being involved in cutting edge of clinical trials and where medical practice is going. That's very exciting. It's challenging because you're seeing all the new research and development that's coming up. And, you also always have patients that are coming in that are always bringing new things along with them and it's new things to figure out. And so you're constantly getting to practice medicine while also being involved in cutting edge therapy development. And you also get a work life balance. And I just think it is such a, you know, opportunity that we have for PAs and MPs to get involved. I'd love to see more people interested in advocating for them getting involved. And if there's ever a site that really seems to be struggling with investigator oversight, or a sponsor is concerned about getting more investigators experience at particular sites. I would challenge them to say, Hey, look, let's look at the PA and NP roles, right? Is there somebody that we can bring on that would have that background and we'll provide that training for the research side of things, because I think it would be a really great advantage for a lot of these sites to stay in research and ultimately be a positive impact on their community and also a positive impact on their business.

Jimmy Bechtel: 16:47

I couldn't agree more, Alyssa, and we talk about that a lot with investigators, right? Like, why don't we build it into medical schools, right? Why don't they talk about clinical research as a career option when you're in medical school, but let's talk about it in PA and NP courses as well. Let's bring it up to them because there's arguably fewer barriers to entry, right? With medicine, with a physician provider, it's a different course, right? We've got a lot of things that we're working against when it comes to trying to build potential research into the curriculum, but maybe there's a little bit more flexibility in a PA or an NP program or an FNP program. So it's an excellent point. One I actually hadn't thought of before, so thank you for bringing that up. Well, Alyssa, thank you so much for providing your insights and your expertise here and your perspective. I think it's a lot for us to think about and talk about about opening the doors for these advanced practice providers and what we can do, how we can utilize them to help address this investigator gap. So again, thank you for being here and thank you for chatting through some of those options with us.

Alyssa Boschen: 17:47

Yeah, absolutely. Thank you so much for having me today. I do really appreciate it. It's an important topic and one that is near and dear for me. So I really appreciate the time and bringing me on today.

Jimmy Bechtel: 17:59

Absolutely. Thanks again. And for those listening, we want to make sure that you don't forget to explore other site focused resources made available to you like various publications and webinar opportunities on our website, myscrs. org. You'll also find a wealth of content and details about upcoming engagement and connection opportunities like our Site Solutions Summits being held throughout our calendar year. Thanks again for listening and tuning in and until next time.