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Successfully Transitioning from HCP to Clinical Researcher
Episode

Lydia Beaudette, Director of Growth and Strategic Partnerships at Centricity Research

Successfully Transitioning from HCP to Clinical Researcher

Brought to you by   | hosted by Joseph Kim

Increasing patient access to research starts with increasing the number of clinical researchers.

In this episode, Lydia Beaudette, Director of Growth and Strategic Partnerships at Centricity Research, talks about building bigger research communities and the process of attracting and transforming healthcare professionals into clinical researchers. Lydia highlights the pending challenges for new researchers related to managing vast amounts of information, technology, and training required for multiple studies. She explains her role in growth activities: leveraging connections, word-of-mouth referrals, and seeking opportunities in specific disease areas. Lydia and Joe also talk about the importance of integrating research into the medical landscape, building communities of practice, and transparently discussing risks and benefits with clinicians and patients.

Tune in to learn about the challenges and opportunities for clinicians as the clinical research world evolves!

Successfully Transitioning from HCP to Clinical Researcher

About Lydia Beaudette:

Lydia Beaudette is the Director of Growth and Strategic Partnerships at Centricity Research, a recently merged company bringing together LMC Manna Research, IACT Health, Aventiv, and True North Clinical Research. Leveraging her connections and seeking opportunities in specific areas, she has successfully fostered collaborations and built networks within the research community. With a deep understanding of the complexities and requirements of clinical research, Lydia continues to be a driving force in advancing the field and ensuring successful research outcomes. She got her Bachelor of Science degree in Human Kinetics and her Master of Science degree in Spine and Muscle Biomechanics at the University of Guelph and is currently completing her MBA through the Goodman School of Business at Brock University.

 

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Joseph Kim:
Welcome to Clinical Research Confidential. On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health, but it’s not for the faint of heart. And so, on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
So today, I’m here with Lydia Beaudette, who is the director of Growth and Strategic Partnerships at Centricity Research. Lydia, welcome to the show.

Lydia Beaudette:
Hi! Thank you so much for having me. It’s great to be on.

Joseph Kim:
Yeah, you’re in very good company because there’s a lot of heavy hitters that have come on this show, and I’m excited to have someone like you because you’re going to bring a very different perspective to clinical research and the content we’ve been talking about here. And specifically what we’re going to talk about today is really your role and how you sort of attract and transform a garden variety clinician into a researcher. But before we get there, I’m always curious about people’s backgrounds and how they get into clinical research, because yours is very different as everyone’s is. So your background is in like human kinetics and biomechanics. Tell us a little bit about your journey from studying that sort of thing and then going into drug research and then certainly your role now, which has little to do with research per se, but creating abundance in the ability for more people to do research.

Lydia Beaudette:
Yeah, I always love this question because I find, specific to this clinical research field, there’s so many of us who kind of fell into it from many different directions, but it does create a very complex and interesting, and diverse workforce, which is what I love so much about this industry. My original education, like you said, was in human kinetics and biomechanics for undergraduate and master’s in science. I chose that by eeny meeny miney mo. I wanted to do either something in sciences or study classical music, it was kind of two very different directions. I chose sciences because I had sisters who had done music and weren’t making any money, so I chose human kinetics as something that seemed relatively interesting and then got more interested in more of the data and math-based spectrum of that. So went into the biomechanics field for my master’s, and then during my master’s, I was working with clinical populations, patients with lower back pain, sciatica, looking at kind of nerve and muscle changes as a result of that condition. So I was doing a lot of going to chiro clinics and physio clinics and talking to people about the types of research we were doing, trying to recruit participants into my study, which wasn’t a registered clinical trial, but it was definitely research on clinical populations. And I loved working in research but was kind of craving a little bit more of that clinical setting as opposed to the academic setting. So essentially typed into Google, clinical research jobs, not really knowing what it was, and interviewed for a job as a clinical research coordinator at the company I still work at today, still at that point, not really knowing what it was, but happily kind of fell into an industry that fit well with and then since then have just moved through a number of positions in clinical research, starting at that classic research coordinator position, working in site operations management, and then moved over to more project management and strategy work in the past couple of years as well. So it’s been a bit of a winding path, but always been going in directions where I’ve been able to stay kind of stimulated and challenged and working with highly intelligent people. So that’s what’s kept me going.

Joseph Kim:
Well, birds of a feather. So what’s interesting is, and we’ll get to this later, is all of your work in biomechanics, I think it’s really had a resurgence in digital health with wearable sensors and that sort of thing. So we’ll talk a bit more about that later, and how that may be, you’re going to start to see a lot more of that in clinical research as well.

Lydia Beaudette:
It’s so funny. Yeah, because I used to do all the analytics just on numbers, data from biomechanics. And then now, as my role has changed, I’ve started getting a little bit more educated from the business side, doing an MBA part-time and specializing in that area in the data analytics, business analytics side of things. So it has kind of come full circle. I was doing an assignment last night coding in Python, and I was like, oh, I haven’t done that since 2013. So yeah, it’s interesting.

Joseph Kim:
Yeah, fantastic. So tell us a little bit about your early days of clinical research coordinating and how that has changed or maybe not changed enough in the sort of eight years since you’ve been doing that versus what it is today.

Lydia Beaudette:
So I started as a research coordinator within endocrinology practice, so working primarily in diabetes trials, cardiovascular outcome trials. And I remember, the second or third study I worked on was a, first study we had ever done with an E-diary, and this isn’t even that long ago, this is 2014, 2015. So it was very much kind of that phase where the working as a clinical research coordinator still had a couple studies where if you have an endpoint, you’re photocopying and by hand redacting your documents to mail into the Endpoint Evaluation Center, you have a couple studies where you’re phoning, physically going on the phone to figure out which IP number to give to them, so it was kind of that transition period between some of those legacy processes and moving over to some digital. And some of the studies, when I started, it was larger, somewhat more simpler, straightforward. The studies had a couple systems that you access, and now I’m doing less direct coordinating. Obviously, I still dabble in it, but the volume of information and accesses and portals and training that you have to go to onboard on a study is just so, so much, and it becomes very challenging to be nimble at the site level because the barrier to access to get somebody added to a study even as a backup is quite high.

Joseph Kim:
Yeah, so with all the tech proliferation and the study complexity, like you’re saying, if study coordinator A has been trained up on all this, should they leave or be on vacation? It’s very hard to then get study Coordinator B to get wrap their heads around everything that they have to do, even if they’re experienced, you’re saying.

Lydia Beaudette:
Yeah, yeah, the hardest part of conducting a study visit and the thing that makes people nervous going into a study visit is not necessarily the ability to go through the inclusion-exclusion properly with the patient, not the ability to know the protocol. It’s, will this tablet work, will I be able to set up this special cap for my medication bottle properly? Those are the things that are the bigger unknowns and the bigger challenges in terms of making sure everything works properly.

Joseph Kim:
Yeah, and I imagine knowing what to do, in what order. The actual sequence of each thing isn’t always very clear either, right?

Lydia Beaudette:
No, not always.

Joseph Kim:
Yeah, well, so, and I want to lean into this a little bit because, in your role now, where you’re trying to transform a healthcare practice into a research clinic, it’s very different if you had been doing this in 2014 versus doing this in 2022, 2023. So tell us a little bit about your role in this growth activity. What does that look like? Do you cold call clinics? Do you carry a bag and knock on their doors? How does that first contact happen?

Lydia Beaudette:
Yeah, so I’ve done very little door-knocking. Often, a lot of it is through connections, word of mouth, people that were clinics that were working with and collaborating with …, saying, oh, I have this friend who has a endoscopy practice over here. They’re interested in doing some research as well. They’ve, I’ve talked to them about my experience. So a lot of it is experiential based kind of word of mouth, or sometimes it is purposeful seeking out opportunities within a specific area. I work very closely with our business development group because if we’re looking at kind of the pipelines of what trials are coming up in indications, seeing which pipelines have a lot of opportunity, which ones may not have as much opportunity, we really want to be staying one step ahead of that in terms of what our site-based resources are. So that might be looking at, for example, there’s a ton of work in Alzheimer’s, mild cognitive impairment, preclinical memory impairments. There’s been a lot of work in that within the past few years. If you had to talk to us five years ago, that was not the case. So sometimes there can be a much more specific targeted approach to say, let’s look for neurologists, for geriatricians, or physicians who are interested in research in that area. Who do we know? Who knows who in that space? And then, what we’re trying to seek out clinicians to get involved in clinical research. We also very much look at what level of involvement they’re comfortable having or comfortable as well as capable having based on, I have yet to meet a physician who does it within the first half hour say, well, I’m very busy right now. Everybody’s very busy, especially with the kind of volume of work we’ve seen come up based on COVID and workforce shortages. There’s a lot of people who have high degree of interest in research and are very passionate about it, but it’s just not the right time for them to get involved in it. They don’t have the time to put their best foot forward in it, so we always like to have kind of the option of you can be involved from a more peripheral sense, maybe referring patients over to the studies supporting with kind of that outreach aspect. And then maybe down the line, if you have been involved in referring patients to studies, you’ve seen them have success or be given new opportunities for being in studies, but you want to be more involved, and we can have that conversation at that time. And then, there’s physicians who want to jump right into it and work as an investigator on the trials, whether that be a sub-investigator first before taking a role as a principal investigator.

Joseph Kim:
So what I’m hearing is like you actually, you don’t just walk in and say, hey, we’re going to turn you into an investigator whether you like it or not. You have several different ways where people ca get their feet wet and do something peripheral, or you can actually, if someone has the appetite and capacity to do it, you’ll change them into a primary investigator right out of the gates.

Lydia Beaudette:
Yeah, so we have situations where physicians have gone from no research experience to being a principal investigator right away. That’s definitely less common, and can sometimes be challenging to get them their first couple studies because they’re coming into it with a less well-developed CV in that area. They may have a ton of really great clinical work, a lot of community outreach, but kind of looking at that breadth of experience and where we can help bridge that gap. Again, sometimes them having those great connections to pharma, if they’ve established themselves as a KOL in their field clinically, it does help bridge that over, and we’ve seen success in that, especially within specialists that are in high demand if there’s a lot of trials in those areas. A lot of other times that we’ve been successful is when we have clinical research set up either peripherally or integrated within a clinic, and then we start working with other physicians within that space, that building, that surrounding area. So rather than having to set up an entirely new clinical research site, which for us is a pretty big capital expense from the equipment, the staffing, the, all that infrastructure that comes and is required to have compliant and properly functioning clinical research site. If we can just build those sites that we have to have a wider variety of therapeutic areas to have more physicians involved in those studies, it helps reduce kind of guess that the risk of a single site, single physician standpoint where if their schedule changes or that pipeline, that pipeline of studies dries up a little bit, then we can have stuff kind of stranded on a desert island. Building up those sites that are more robust, and then also having physicians, even if they’re not directly working on the same studies, they’re not in the same indication; they can still learn from each other from that. How to be excellent at research perspective.

Joseph Kim:
Yeah, so what I’m hearing is that like this idea of communities of practice is really what makes clinical research take off at a single inner regions. And this idea of like opening a clinic that’s self-contained and has no affiliation oftentimes isn’t the best sort of thing. Tell me about, yeah.

Lydia Beaudette:
I was just going to say it almost naturally happens as well in, like, you sometimes see like the mom-and-pop clinician practices as like a standalone office, but very much more often, you see medical practitioners in kind of a shared medical space where there’s your lab facility, your imaging facility, your pharmacy, your GP office, a couple specialists office, that kind of coming together, joining together happens. Those synergies come together even without research involved, so if we can have research, be a part of that medical landscape, and be part of that service that’s offered within that larger number of components of the medical system, that’s where it starts to just kind of be a piece of the puzzle and fit in naturally as opposed to be kind of that sore thumb in somebody’s ear being like, find your document, sign your documents, enroll your patients. If you’re just naturally part of that healthcare system, that’s going to be a much greater chance of success than like an island or very standalone.

Joseph Kim:
Yeah, now let’s talk about this concept of informed consent, because it’s a centerpiece around clinical research for patients. What’s your version of informed consent when you start talking to a doctor about like, hey, here’s an opportunity, how do you lay out kind of risks and benefits for a doctor new to the clinical research space? And maybe what’s the most surprising thing they end up sort of discovering when they jump in?

Lydia Beaudette:
I actually love that concept of you’re almost like consenting physician to being involved in research the same way you would consent a patient, I should make a document for that, though.

Joseph Kim:
You should.

Lydia Beaudette:
But like when we have a physician or healthcare provider, I should say more broadly, but when we have a healthcare provider in that conversation about whether or not they want to work in research, and also whether they want to work in research, there’s many ways to work in research. You don’t have to join in with a research site network to be involved in clinical research. Technically, an investigator can do it completely independently, there’s just a much higher failure rate in that situation. But one of the things that we have found never works is hiding anything or glossing over things, or being completely optimistic and making projections, or anything that’s just unrealistic. I have found, in almost every situation, people very much prefer to hear about what this is actually going to look like in terms of how it impacts how your practice flows, what opportunities your patients have. I’m a huge advocate for clinical research. I love to see physicians be able to integrate that into their clinical practice, offer those opportunities to their patients, but it’s not a walk in the park, and we are definitely an industry where there are challenges out there that will impact as much as we try to shield it, but that will impact our physicians that are involved. So I always very much prefer to keep as much as possible above ground and go into it saying like, here’s some of the amazing, wonderful things we can get out of working together in clinical research. Here’s some things that people have found frustrating about this, and then we’re going to find a … And then if any of these things that I’m talking about or I’m saying are making you feel like, oh, I’m not so sure about it, don’t dive in unless we’re both sure. So it’s a two-way conversation, the same way consenting a research participant is, but if you’re able to both come out of that feeling very confident that same way with the research participant, the study is a good fit for me, I’m a good fit for the study with the healthcare provider looking to be involved in research. They have the motivation factors. Is that extrinsic? Is it very money-based only, is the only motivation that’s kind of a yellowy flag to us, or are they motivated by the increasing that the, increasing the therapeutic horizon for their patients, or contributing to science, or building their ability to be a KOL within their field? Those are much more long-lasting motivating factors than, I just want an extra revenue stream. It’s not bad to have an extra revenue stream, but if that’s your only focus and then you hit a study opportunity where you’re getting a really high screen fail percentage, and the contract was set up in such a way that you’re not getting compensated properly, but you still might get another patient through, and our patients are really going to benefit from this, you’re going to run into situations where you have to have that balance between which streams of motivation are most important.

Joseph Kim:
And what might be.

Lydia Beaudette:
That two-way conversation I think is so…

Joseph Kim:
Yeah, when I think about patients, one thing that always turns off patients is like there’s going to be ten lumbar punctures, something like, wow, well, thank you for telling me now because this is not something for me. What’s the equivalent of ten lumbar punctures when you start to tell a site or a potential site that, hey, here are the hard truths I’m going to tell you, and what are some of the things, you know, might turn off 25% of them right away, which is a good thing, right? You don’t want them going in with a sugarcoated version of it.

Lydia Beaudette:
I think some people, when they look at being an investigator on research, they don’t quite realize the volume of the administrative component to it, even if that’s as shielded as possible. But there’s no way around the fact that you have to be trained on your study, and you have to have oversight over things like the regulatory documents and processing of those. So for a new investigator that the kind of that balance between having, especially a principal investigator, having the responsibility for conduct of a study on your shoulders and your liability, yet working with a group that you’re unfamiliar with, most people in those situations will feel a higher burden of having to go through every document that they’re signing off on in detail and reviewing through the training and detail, and that does take a long time, and especially when it’s your first time going through it can be a little bit overwhelming. So especially for investigators that are kind of new to it, that burden of liability responsibility can feel quite heavy or hurt some people. And then the second thing, even for once, you’re kind of an old hat in it and have done research for a long time. There’s still a factor that every study that we have starting up, you’re going to have to do training. You’re going to have to do your sign-offs, your review. You can’t really get around the fact that you have to be familiar and trained, and knowledgeable on the trial that you’re doing. And also, kind of the third lumbar puncture might be a little bit to the effect that in this industry still sites, there is many situations where clinical research sites are put in situations where we’re signing contracts for research studies that don’t have defined budgets yet, and we find out when the study is about to start, that we’re actually going to be not paid well for it or not compensated for screen failures, or our patients won’t be paid for unscheduled assessments, or the stipend doesn’t actually line up with the costs that the patient is incurring to participate, or the vendor for the E-diary has changed last minute, and it’s one that’s unreliable and not set up well in our country, and we’re delayed six months. There are those forces at play outside of control of the site, the way that our investigators are seeing the study or seeing the industry, and that can definitely be the kind of trickle-down of those dysfunctions, but functions we’re improving upon within, like industry-wide.

Joseph Kim:
Yeah, I mean, because if you think about like the garden variety healthcare provider, they may have X amount of systems that they’re going to use year in and year out. Maybe there’s a little bit of turnover, but for clinical research, there’s a new set each and every study and new combinations and permutations. And to your point, they have to get trained on all of those for each study, and keeping that straight can be quite a headache.

Lydia Beaudette:
Yes, yeah. Just the access is, and realistically, even as a research coordinator, it feels overwhelming when you’re starting a new study, but you get used to it because you’re accessing them and using them frequently. For an investigator on a study, every three months, you’re asked to go in and sign off on the electronic case forms, the ECRS. You do that every three months. Do you think I remember how to access that when I do something every three months? Absolutely not. So then you’re going to feel less competent in your role because you’re having to pull some, your research assistant over saying like, okay, how do I which one do I go to? Where do I go? You don’t feel like an expert or competent in something when you’re doing it so infrequently, especially when it’s different every single time you’re doing it. Sometimes there’s an element too, when these systems are designed, they’re being designed for the people using them most frequently, so a research coordinator or data manager, and they’re definitely not for people using them infrequently, but I understand, but it doesn’t make smart people feel smart.

Joseph Kim:
Yeah, it makes it hard. And you know, the tables have turned because I think physicians are used to being the expert, and when they’re not the expert, and it seems very frequently in the context of research, it can be disconcerting. Speaking of which, how do early investigators, how do they take to the notion of a CRA coming in and saying, here’s what you did wrong? How does that usually play the first or second time?

Lydia Beaudette:
That’s one of those when you’re speaking about that like two-way fit conversation where people who have, and we all know there are some people in every field, physicians included, that have the chip on the shoulder or come into it with the mindset that I’m the expert, I know what I’m doing. And I would say sometimes, for people entering into research, you have to take a little piece of your humble pie and recognize that you’re the expert in the condition, you’re the expert from the medical perspective, but from other perspectives. So, for how to operationally run a clinical trial with the regulatory requirements are how to sign off on the EDC platform, those areas, that’s why you have your support team in place. So kind of just stating that clearly, being like you’re the expert in the medical aspect, we’re the experts on how to run the clinical trial that’s come together so we can be excellent together so that everybody kind of simmers the ego and is able to move kind of nicely down that path together. The challenge sometimes comes, like what you were mentioning, where somebody starts questioning the medical decision that was made. So for example, like a CRA comes in and says, are you sure this ECG was not clinically significant? There was something noted on the automated signing. You didn’t report this properly. So sometimes those clashes might be a little bit uncomfortable. The biggest thing that we always try to work with our investigators on is reinforcing the fact that the medical decisions and discussions are theirs to make. We always tie it back to if there’s specific guidelines in the protocol for how to manage certain situations or obviously adverse events of special interest, any of those endpoints, any of those specific areas, we can make sure that we’re following that, but there’s a lot of components that are, as per investigator, discretion, and I think as much as possible, we should be kind of supporting and trusting our highly recognized medical professionals in those spaces.

Joseph Kim:
Yeah, you know, a few years back, it’s maybe ten years back even. I remember seeing some statistic, like 80% of physicians who try research for the first time are one-and-done, like people try it once. What has been your hit rate with physicians or healthcare providers who jump in, and how many of them say, yeah, this was great, but I’m never doing this again? Is it that high, or like, are you able to mitigate?

Lydia Beaudette:
We’re nowhere near 80%. The 80% is across the board, right? So a lot of that 80% is coming from the people who try to do it all on their own, and there’s a lot of misconceptions about how easy it is to do research initially. I think a lot of people come into it like, oh, I have patients with this condition. They talk to an MSL in that area, they talk to the drug reps. They’re like, oh yeah, that’d be great for that study. I see five of those a day, it sounds fantastic. And then, they start going through that checkbox or list of what has to happen and realize that their clinic nurse might not actually know clinical research, and then they’re non-compliant. And we’ve seen so many of those stories and cases. It’s a lot, a lot, a lot of work to do it well independently, and it’s a lower success rate in that sense. Within more of kind of a networked or a supported model, which there’s a lot of groups doing now at this point, I would, I don’t know exactly what the number would be for a percentage of physicians that do a couple studies and then decide not to continue.

Joseph Kim:
Well, even for Centricity, right? Yeah, what’s been the approximate sort of turnover of one-and-doners, I guess? What’s the magic thing that you do to make sure that it’s not 80% of people who try it for the first time turn away?

Lydia Beaudette:
I would say it’s less than 25%.

Joseph Kim:
Oh, that’s great.

Lydia Beaudette:
Do a couple studies and then finish. But I should actually go look back historically and validate that number. But I would say the biggest difference maker for like doing research independently versus like an established network is realistically just that the upfront investment you have to make to set a research site up to have reliably trained research coordinators, it’s just that risk reduction in terms of being able to do a study in a compliant manner. So risk reduction, and then the second component would be kind of that operational knowledge of how to do it efficiently and run it in a way that’s not going to be losing money if you don’t negotiate a contract properly, if you don’t have the right resources or support systems in place, you can very easily run into a situation. Especially if you have a bunch of those patients and you recruit a ton of patients, you can extremely easily run into a situation where you have audits or inspections coming, where there’s findings, where you’re blacklisted from doing research, or you can run into a situation where you do what you think you’re going to make all kinds of money, you don’t realize kind of the hidden costs of doing research, and then you realize that you’ve invested a huge volume of time and effort. You spent $10,000 on a centrifuge, and then exclusion 17 meant that three-quarters of the patients you thought were going to be in the study actually didn’t qualify, and you end up losing money on the venture. So it’s knowing that the, operationally how to run a study efficiently, knowing from a business sense how to set it up properly, having trained and qualified staff working on the study with you, there’s just so many components to doing research, and we see these established sites or small networks or large networks. A lot of them have come from the small number of successful single-site start-up situation, so the ones who got it right often end up kind of growing into larger entities within the industry.

Joseph Kim:
The way you framed that was really great because there are things that you can do in almost ensure success, which is like foundational infrastructure, good processes, understanding how to operationalize things in an efficient way. The one wild card, it seems like, is when sponsors say, here’s the study. If they’re not really transparent about like what the study entails, you could end up agreeing to a budget that puts you underwater, and that’s no fault of the physician or fault of your services. It’s this idea of really helping the site understand what it’s going to take to pull this protocol off. And what I’m hearing.

Lydia Beaudette:
Accurately … it.

Joseph Kim:
Exactly, and what I’m hearing more and more is, when a study is going to make a site lose money, the site just stops doing it. As they should, like, why would they continue to do it?

Lydia Beaudette:
Yeah, yeah, go back and renegotiate your budget. I mean, don’t get me wrong. Situations where we’ll take a study that’s, like, barely break even or, like, questionably break even, we will, in very specific situations, go down those paths if it makes sense from a long-term perspective of, if we do this opportunity we’ll open up this set of doors. This is something that we have a physician that’s worked with us for 20 years who’s extremely interested in this. We understand it’s not the highest-paying study, but it’s something that’s like near and dear to the ability to treat this group of patients. A lot of us get into research to be able to contribute well to our healthcare systems, right, to be that positive contribution. And we need to run biz that’s going to be functional, but it’s also not the only component that’s considered when looking at a trial. But I think definitely for people who haven’t been involved in research before, it’s one area that is hard to learn, I guess, is how to properly negotiate our cost or budget for those studies, because sometimes what comes down the line initially is quite malleable, if you know what to.

Joseph Kim:
Yeah, and I have to imagine the ability to effort track, let’s call it. It can be difficult at a site too, because there’s all this tacit knowledge and behavior that’s not tracked. So to do that in a rigorous way becomes hard too. So oftentimes, you may not know that you’ve lost money until you’ve finished the study, yeah, exactly. Let’s talk about, because we’re running out of time here. I know you have to go, but I do want to make good on my promise of like things are coming full circle for you with regard to a lot of wearable sensor studies and digital health studies that can tap back into your biomechanics education. Are you seeing more of this kind of work happening? And what are some of the challenges to research with wearable sensors studying movement?

Lydia Beaudette:
Yeah, I haven’t personally worked in a lot of them yet, but we’ve definitely seen more opportunities with that space coming down the pipeline, and it’s more common that type of opportunity is popping up as opposed to a couple years ago as opposed to five years ago. One of my biggest things that I always like to kind of advocate for at the site level is involving our potential research participants in getting feedback or insights into how this protocol or device or wearable sensor would kind of fit into their day-to-day. It’s very easy to drool over the volumes of data we can get from sensors such as wearables. And don’t get me wrong, I love data, I really enjoy the insights you can gain from it, but from the research participant perspective, we need to understand the potential burdens for their life, and that decision that they’re making to be in the study can sometimes look a little bit different for those trials. I know it’s a little bit different, we have, I always love to participate in studies as well as much as I can, and I think that comes from doing a master’s degree in a very tight-knit human testing department so, and this was back during my master’s. I did a study where you had to wear the 24-hour ABPM, the ambulatory blood pressure monitor, and it would go every 20 minutes during the day, every 30 minutes at night, and I got to tell you, that is no fun. That is absolutely no fun. I didn’t sleep for three nights. So now, when we do these hypertension trials, and there is ambulatory blood pressure monitoring, the way I explain that during an informed consent is actually quite different from how I would if I had never done it before. So I do kind of very much believe in people explaining the studies, people involved in the studies, making sure you have a complete and full idea of how that’s going to impact your patient. Your patient is the one, your participant’s the one wearing that device and collecting that data. How involved are they in dissemination of the insights from that data? If somebody is wearing a continuous glucose monitor for a two-week period and changing it off and not going in the hot tub and doing all those lifestyle changes to wear it? What insights are they going to get from that data, or is that all completely blinded or hidden from them? So I always advocate for kind of sharing as much as possible so they get something out from it as well, and then making sure that that initial conversation, we’re not going to be running into retention issues. If it’s kind of an annoying thing like an ABPM. I haven’t worn a CGM for two weeks, but I can imagine that would have its negatives as well.

Joseph Kim:
You’ll be surprised some people just voluntarily do it for health and wellness reasons. But I, your point is well-taken, right? Wearing something for an extended period of time isn’t always a picnic.

Lydia Beaudette:
Yeah, very different. … to your Apple Watch, and they’re tapping into something from it, and it’s something that’s already part of your day. I think we should see more research studies gaining insights from that type of data that we’re already easily able to collect. But if there is kind of that extra burden on the participant, A, compensate them properly, and then, if it ethically in the study makes sense, how much information are we able to share back to them if they want to learn?

Joseph Kim:
Lydia, it’s been so great to have you on the show. I love hearing about how you’re trying to create abundance in research and grow the market of people who can actually do this responsibly and with excellence. Thanks again for joining us, and I hope to see you at a conference again soon.

Lydia Beaudette:
Awesome, thank you so much, Joe.

Joseph Kim:
Thank you for tuning in to Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some war stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com. This show is presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • Building communities of practice and establishing partnerships are essential components for success in clinical research.
  • Pay attention to hidden tasks in research: accurate budgeting and negotiation is vital to ensure your financial viability
  • Clinical research conduct is more complex than healthcare, driven by protocol design, technology proliferation and administrative burden unique to each study
  • Integrating wearable sensors and digital health in research presents opportunities and complex challenges, requiring careful attention to participant experiences.
  • Clinicians transitioning into research should anticipate administrative responsibilities and liability.
  • Successful growth in clinical research often stems from start-ups that expand into larger entities within the industry.
  • Collaboration, transparency, and continuous learning are pivotal in navigating the intricacies of the clinical research field.

Resources:

  • Connect with and follow Lydia Beaudette on LinkedIn.
  • Follow Centricity Research on LinkedIn.
  • Visit the Centricity Research Website!
  • For more information about Research Confidential, please visit ProofPilot.com.
  • If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com.