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CRAACO: The Future of Clinical Trials
Episode

Jennifer Byrne, CEO at Javara

CRAACO: The Future of Clinical Trials

Brought to you by   | hosted by Joseph Kim

 

Clinical Research is not an individual sport, it is a team sport in which one variable affects every outcome.

In this episode, Jennifer Byrne, CEO of Javara, talks about taking a different approach to clinical research, improving it, and changing the narrative it has been associated with so far. In their conversation, Jennifer speaks about what an IRO is and why this type of company is different from other pharmaceutical companies conducting research nowadays. She presents CRAACO as an approach to clinical research and its intentions by giving some examples of its application. She brings awareness to different issues that occur in clinical research, including mistrust, complexity in systems and protocols, transparency, and teamwork. For her, the future of clinical trials will be in patient-centricity, understanding centricity as including the patient as part of the team.

Tune in to this episode to learn the hard things about clinical research and how to manage them!

CRAACO: The Future of Clinical Trials

About Jennifer Byrne:

Devoted to leading organizations, building teams and partnerships centered on advancing the clinical research enterprise; namely to better connect patients and providers to clinical trials. CEO of Javara, former CEO of PMG Research, and Founder of Greater Gift (501(c)3), Jennifer has vast involvement in the clinical research enterprise across collaborations with hundreds of life science organizations, Contract Research Organizations (CROs), technology, healthcare systems, site organizations, CDC, and other research service providers for the direct execution of over 7,500 Phase I-IV clinical trials which have included over 100,000 clinical trial volunteers. A clinical research business leader thriving on building high-performing teams and trusted partnerships while navigating the complexities of the evolving healthcare and bio-pharmaceutical challenges and opportunities leading to differentiated and better outcomes for all stakeholders; namely the patient.

 

Recognized as a CenterWatch Top 20 Innovator and is the recipient of the ACRP’s 2018 Innovation in Clinical Research Award and the NC Biotech of the Piedmont Region Innovator of the Year. She currently serves as Board Chair for Javara Inc, Chair, Greater Gift, Board of Trustee for The Association of Clinical Research Professionals (ACRP), and Advisory Chair for the Wake Forest University Masters in Clinical Research Management. Additionally serving as an Advisory Board member to CISCRP, Wake Forest Institute of Regenerative Medicine, FCA Health Innovations Fund, North Carolina Biotech of the Piedmont Triad and serves on the Leadership Advisory Board for the Avoca Quality Consortium, CRAACO, and the Workforce Innovation Steering Committee for ACRP.

 

Research Confidential Jennifer Byrne: Audio automatically transcribed by Sonix

Research Confidential Jennifer Byrne: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

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:
Hi everyone! Today I am here with the amazing Jennifer Byrne who is the CEO of Javara, what we call an IRO, I’ll let her explain, but Jennifer, you’ve come to this research industry with a long history, but what I love maybe most about you, well, there’s many things I love about you, but what I really love about you is that you’re not just some, like, executive that saw things from an ivory tower. You got your hands really dirty in the very beginning as a study coordinator. So you’ve really seen it at literally all levels of execution, management, and strategic vision. Welcome to the show, I’m so glad you’re here.

Jennifer Byrne:
Thanks, Joe. This is, I’ve been looking forward to this, and I’m just so excited to have this conversation because we’re going to be talking about hard things.

Joseph Kim:
Hard things.

Jennifer Byrne:
Not the beautiful things, the hard things, making our way to beautiful things.

Joseph Kim:
I hope one day, yes. So let’s start at the beginning. Like give us like a quick history of your journey in clinical research starting from those days as a young study coordinator.

Jennifer Byrne:
Yeah, so it has been a long journey, but I’m going to tell you, it’s been a wonderful and rewarding journey. As you mentioned before, I fell into research literally right out of college as a research coordinator, which I can tell you on day one, somehow or another, I heard you’re going to be working with pharmaceutical companies, it’s relationship-based, something with patients. And somehow my interpretation of that was that I was going to be a pharmaceutical sales rep. So you can imagine on day one when I was handed a protocol and basically told to kind of figure this out. So over all of these years, which has spanned decades, I think that not only have I had an opportunity to kind of grow and evolve in my role and contribution, I think what I have had almost maybe even a little bit as a superpower for today is that, I think it’s been over so much time that I’ve been able to see trends not only on the industry in life science but simultaneous, because where I’ve always sat really at the patient and at the provider-physician, which is in the healthcare realm. And so even having that opportunity over all of these decades to see simultaneous change in healthcare and delivery of healthcare, public health, how I think about clinical research really is more a component of public health than that of life sciences.

Joseph Kim:
Yeah, interesting.

Jennifer Byrne:
And all the changes that we’ve seen in the industry and evolution over the years.

Joseph Kim:
Yeah, so we’ll definitely talk about that tension there when it’s happened and sometimes when it’s aligned and there are some sweet spots there, which I think part of what this … vision is all about, we’ll talk about that also, really leans into. But before we go there, let’s talk about what, teach the audience would an IRO is.

Jennifer Byrne:
Yeah, so the IRO is the integrated research organization, and the integration piece of this means that we are really partnering, building, and I want to really emphasize, building trusted long-term relationships with healthcare organizations. So the integrated piece of this is that we are integrating a services, a highly, technology-enabled services delivery model with healthcare systems. The north star partnership model on that is that both sides are making a commitment that in this journey together we will be moving towards again that north star of clinical research being on the menu of options for all patients across the entire organization. So you’re taking what has been oftentimes a departmental approach or a one-system approach again to that enterprise.

Joseph Kim:
So tell me about the mistrust there. Is it still there between physicians and researchers?

Jennifer Byrne:
I think that some mistrust still remains, but I’m going to say it’s probably more a remnant of a narrative in terms of what research in the past has been. It’s amazing how many times we get in front of a group of doctors, and their perception of research is based on a very limited exchange that they had, whether it was a patient of theirs who might have participated in somebody else’s trial, whether it was research as it was conducted within another academic medical system when they were in training. So, you know, there’s just a lot of legacy. And I think we, at least I’m going to say for myself when I’m interacting with physicians in new healthcare systems, and even some of our established, I think it is, you have to be really intentional about the current state. And, you know, I think that the industry’s, I’m going to say, much more genuine commitment to patient-centricity has been really, really helpful. Because that’s the opportunity to level set, because now we’re actually creating much more of an even playing field about research really being centered on not the pharmaceutical company or not the data or not the commercialization, but really centered on, in not patients of the future but patients for today.

Joseph Kim:
Yeah, let’s dig into that because this is where it gets probably very difficult because in the pursuit of being patient-centric, you know, research really isn’t designed to take care of the patient, it’s designed to see if this drug works and is safe. Now, there’s always probably misalignment between the pursuit of science and the care of the patient. So do you often see things commonly get misaligned in those two pursuits?

Jennifer Byrne:
Well, see, Jee, this is where I’m going to kind of challenge you, I think this is where we have the opportunity to change the narrative. Why can we not expect that research can be an and versus an or? So fundamentally, I believe that pharmaceutical companies should absolutely expect the people who they are working with to carry out research on their own. They should absolutely expect that those people have a responsibility and as an ambassador again to public health, to be positioning research delivery with the expectation that phenomenal standard of care will happen as part of that process.

Joseph Kim:
Yeah, yes, all right. So now I’m on my heels a little bit here. So you’re right. We should definitely think to change the narrative. But isn’t it still true, and I’m leading you here, isn’t it still true that sponsors are not trying to care for that patient? And so there are missing things. There are things that are missing in protocol A, that you might have to fight for on behalf of the patient. Do you have any examples of those? Am I right or am I just still, like clinging to the past?

Jennifer Byrne:
Well, I think that, unfortunately, sponsors and protocols are, you know, almost a boilerplate. And so in my experience, sometimes there’s, they’re a legacy. It’s kind of a boilerplate approach, and this is what worked for this particular patient population. I mean, it’s amazing when the average protocol now has, what, 70-80 protocol inclusion-exclusion. I mean, tweaking one inclusion or exclusion point can fundamentally completely shift the makeup and the phenotype of that particular patient population. So I think that the risk is, that when sponsors are developing programs and protocols and when they’re going on autopilot and they are making assumptions based on what happened in a previous project without doing some pressure testing on that, taking it back to the field. But I have to say, you know, especially over the past few years, I do see where companies are putting focused programs and groups together where they are seeking that type of input, and that’s not just lip service. I mean, we are definitely seeing plenty of examples where I think getting the voice of the patient, getting the perspective, not just of the physician, but I think historically there’s been a lot of emphasis in terms of getting input from key opinion leaders. But now all the forums that are developing kind of across the industry with the boots on the ground, the research coordinators are in the case of Javara trial navigators. So I think those are all really good and positive.

Joseph Kim:
Yeah, it’s getting better. It’s getting better.

Jennifer Byrne:
Yes.

Joseph Kim:
But what about protocol complexity? Because if you compare a protocol from when you first started, they probably look quite different now. Like there’s so many more procedures, the algorithms built into the protocol, right? If A and B equals five, then do C, but don’t do C unless A and B equals five, Right? That sort of stuff. Are you finding the complexity challenging, particularly because you’re an IRO embedded within a healthcare system?

Jennifer Byrne:
Yeah, well, I mean, that is an added layer, but just kind of across the board, just to share some data points with you. I’m going to say probably ten years ago, and if you just normalized and you look whether you are looking at less complicated vaccine trials to very, very complicated patient populations, Alzheimer’s, for example, other end of the spectrum, I’m going to say in my experience and through organizations that I’ve been involved with from a coordinator standpoint and an investigator standpoint, you know, probably ten years ago, on average, that complexity issue really meant that we on average could, let’s just say, manage probably more like three and a half to four patient encounters per day. Within my organization, and we’re still a relatively nascent organization, still fine-tuning technology enablement, best practices, that number is probably more like one to one and a half.

Joseph Kim:
Wow!

Jennifer Byrne:
… per day. So it’s a real, it’s a phenomenon, and it’s not just the complexity of protocol and the data points that are being included, but it is the challenge around a lot of different numbers. So the number of technologies right now that are being used, and I think this is actually a good development. I think that when you start talking about even the systems in terms of how we are tracking clinical trial progress, even beyond the protocol, but in terms of just tracking clinical trial management systems and all the e, you know, e-consent, e-reg, you when you kind of start to pile all of that in, you know, we, I do believe that we are at a moment in time where we are at crossroads, where there’s just almost this gridlock. Imagine you’re in the big city and it just so happens that all the forces are coming together and you’re at gridlock. But I’m really optimistic that I think we’re at that moment and now these solutions we are really starting to think about, I think, some of this complexity and how do we pivot that, and maybe this is where the IRO perspective and what we’re seeing comes into play, because I think now some of these solutions are, okay, rather than putting another solution or putting in another technology, how do we think about simplifying and how do we start moving clinical research into standard of care oriented general workflow?

Joseph Kim:
Yeah, I mean, the technologies aside, well, let’s focus on the technologies for a moment because some of these are just, they’re just, it is what it is, but you have to juggle and manage all these different portals you have to go into, and even that alone seems to be pretty, pretty difficult. And but now you’re raising the bar and saying, like, well, how do we then also weave it into healthcare itself? Particularly if you’re part of that health system, where do you see some of the early wins of doing that? Like, you can’t get all of it in there, but like what about screening or maybe patient data return or physical exams? Like do you see like a good early touch point to begin to weave healthcare and research together?

Jennifer Byrne:
Well, I mean, I think it begins with, first of all, how our electronic health records are being leveraged and electronic health records are not the end all-be all, for sure. So the complexity in terms of the data encoding and ICD nine and ICD ten and all of those things, I think that solutions along the lines of protocol, inclusion-exclusion matching against an electronic health record, those are really important advancements. You know, how are we not looking to find additional outside data points and resources apart from the health system? But how are we building more meaningful engagement with healthcare systems, right, that have not just electronic health record, but other data sets and keeping that in more of a closed loop? You used the word a little earlier, when your questions around trusted, and Joe, I just can’t underscore the importance of, it’s not just finding that right patient and how we get to finding that patient through technology. But then the pull through on that is I think, again, keeping that patient within their circle, their care circle. So it’s not just sharing the data with the patient, it’s making sure that what’s happening with the patient in the clinical trial is easily available to the entire kind of care community around that patient. And I think the shift is that while and I get it from a bioethicist standpoint like, okay, we can’t really talk about them as patients. We’ve got to talk about them, those clinical trial participants, as subjects. Well, the reality is that the best contributor in terms of the data set, is an individual that we have a holistic view in terms of what has happened to that individual and to that patient.

Joseph Kim:
Yeah, I see what you’re saying. So it’s, with all the talk of patient-centricity, it’s not just like throwing it all on the patient. It’s making sure other professionals and the care team and whoever else needs to know is also part of that team. So I think we like to use the word patient-centricity, but what I’m hearing is more just like treat them as part of the team and not just as like a subject where you’re just pulling data out of them. And if we can do that with technology responsibly in two ways, not just pulling health data into the research, but responsibly giving, sharing that back in the right moment with the care team. You know, you can be more patient-centric by not just like piling it on the patient, but connecting it with the larger care team for sure, yeah. How about, let’s go back to this whole concept of Clinical Research As A Care Option. So for those who don’t know this acronym, it’s CRAACO. And I’d like to credit you as the innovator of this whole concept because it didn’t exist until you started talking and showing some of your early use cases and really interesting positive outcomes with like Wilmington Health and other health systems that you were doing this in the early days with. Give the audience a sense of, really, the beginning of CRAACO, what it’s intending to do, and what it looks like in practice.

Jennifer Byrne:
Yeah, well, I mean, thanks for that overview. I will say I had tremendous benefit of, at a moment in time, working with physicians and working with an administrative CEO of Wilmington Health, in particular, Jeff James. You know, I think, you know, where it really originated from was earlier discussions about why within a health system, why do you have a doctor search and why do you have resisters to research? And again, I’m going to take it back to, at that time, the narrative was very much about, okay, the adopters were those physicians that were really comfortable with working with pharma, hired by pharma, right, to do the work of pharma, and, that was the great divide. And fortunately, it was kind of a moment in time that when we were trying to sort through and kind of address, okay, well, where is the root cause coming from this? We started to look at data in terms of what’s really in it for the patient. And we had so many anecdotal stories and I had had those anecdotal stories from physicians over the years, we just never had stopped to actually look at data. And so when we started to look at data in terms of kind of the doctors and the non-doctors, in a way we kind of eliminated that and said, okay, well let’s go to the data and let’s see what the data tells us in terms of what’s actually happening with the patients. And so when we started to look at claims data, for example, like forget the CTMS, you know, we’re not getting the EDC, the electronic data capture, we’re not getting any of that information, let’s just look at the facts. And so having an opportunity to again start looking at data, we saw some really compelling, amazing trends. And that was that for those patients, and we were looking at the time over not just a trial, but we were looking at portfolios of trials. We were looking across ten different diabetic trials or ten high-risk cardiovascular trials. What were the trends in terms of the patient experience? What was going on with them from a health standpoint, what was going on from a cost standpoint over a period of time? And that experience, I think, has withstood the test of time, you know, and we continue to see this validated. So that clinical research really becomes an opportunity, it gets back to the point that I made a little earlier, if you change the narrative around that, that clinical research actually can be used if you use the data, first of all. And rather than being driven to do trials that are of scientific interest to physicians or what’s the latest trial that comes to you from a pharmaceutical company, in this case where CRAACO began, we started to look at, wait a minute, we’re seeing that people who are enrolled in clinical trials long term, even after the clinical trial, are doing better with chronic conditions. Why are they doing better? They have had a high-touched care delivery experience.

Joseph Kim:
They’ve learned more about their selves, yeah, yeah.

Jennifer Byrne:
And when, sometimes we put really negative terms around clinical research, like the burden of informed consent, well, another way to view that is informed consent can be a wonderful opportunity, perhaps with a newly diagnosed patient, with a patient who has not had the opportunity to have maybe a bit more kind of healthcare acuity, for example, to learn more about their condition and the impact and the power of that. And so is it really the burden of consent or is it an opportunity for having a more highly engaged healthcare consumer? It’s not the burden of, you know, serial repetitive, concomitant medication checks. It’s that opportunity, if you’re you have a positive reinforcer in terms of the importance, of being compliant. And those are behaviors that last far beyond a clinical trial. And so from some of this data we saw, like material differences in terms of readmission rates with clinical trial participants and not just at Wilmington Health, this has been studied in other centers as well. So, yeah, you know, I think it is, you know, the way we’re thinking about this today from an IRO standpoint and with our healthcare partners, the starting point to this is that, look, we are going to partner together. We’re going to build a trusted partnership, there are a lot of aspects to this. There’s a legal component to it, what’s the technology, what’s the compensation piece to this standard operating procedures, building the team, all of these things. But let’s actually, as a starting point, let’s understand what are the unmet needs within the patient population that you’re serving. Where are those pockets of patient populations that can actually benefit from concierge medicine? And we’re not going to hide it. I mean, of course, we have an ethical, moral responsibility to ensure that people understand the difference between research and just exceptional care delivery concierge care, but let’s use that as the starting point.

Joseph Kim:
I mean, you know, leave it to you to create some jujitsu out of this and turn something that just is universally accepted as terrible, like the informed consent or being poked with a needle each time as a way to educate and be dialed into your healthcare and just learn more about yourself, and, you know, I never really thought about it that way either. And in terms of like elevating it even further, like where is it going? This sort of level of concierge care, which is only afforded by the most wealthy, right? Where they don’t have to worry about anything and they have personal doctors, on some level, yeah, research can absolutely be the highest level of care, certainly in certain indications for sure.

Jennifer Byrne:
We regularly poll our patients about experience and you know, most recently we’re generating data on an ongoing basis for reporting it out on a quarterly basis. But on that question, so there’s standard questions that we’re asking every clinical trial participant within our shared programs with our healthcare partners. And on the question about, do you feel more engaged with your overall health and well-being? There is that question that is asked. We have had quarters where that number has been 100%. The lowest number that we have had to date has been 95%.

Joseph Kim:
You know, if I didn’t know you, I’d say you were lying. That’s really, that’s amazing. I believe it, wow, and that’s all because, just the amount of effort that the doctor can now give to the patient in pursuit of research, there’s just so much more interaction. That’s more than the ten minute, you know, how are you feeling? Let me fill out my chart, you know, take two and call me in the morning. There’s just so much, so many more touchpoints. Is that what you attribute it to?

Jennifer Byrne:
Yeah, absolutely. But Joe, can I pivot? Because I know that this was about kind of the hard things about research. Can I bring forth one?

Joseph Kim:
Yes, please.

Jennifer Byrne:
From an industry standpoint. So here’s what’s difficult, because what we’re doing, fundamentally, what we are doing is we are leveraging clinical research as a tool in the toolbox from a health system standpoint to address unmet needs. We are doing that. And we have to overcome some of these barriers, these historical barriers, those negative narratives, research is too hard. It’s, you know, it’s a burden to patients, so we’re having to overcome all of that. Reliability and transparency become a huge issue for us to be managing at the ground level. So it happens all the time that there fundamentally is going to be a change in terms of the project plan, start times, enrollment going on hold. And I understand we’re in research and there are at times it’s obviously very appropriate that in the blink of an eye, some change needs to happen, but more often than not, I think that there are administrative issues that can come into play or, you know, supply chain issues or workforce limitations. And for sites to not have a heads up, sites need to know if there is going to be a delay in a program when we have brought forth a clinical research opportunity. Like that transparency is really, really important because we’re at the ground level with patients, and physicians sometimes have been putting on hold some type of treatment transition for a patient in anticipation of that patient participating in a clinical trial. You know, people have rearranged their schedules, we’ve already been looking out ahead, and so sudden shifts can heighten the mystery, quote-unquote, mystery around research. And that would be my ask. That would be my ask that in terms of kind of that patient-centricity piece of it, that there is more transparency, right, when they’re going to be delays and when a timeline shifts. And to get notified when we believe that we have drug supply available on Monday and people have been queued up for that only to get a notice on Thursday afternoon, or worse yet, on Friday that drug supply is not going to be available or lab kits are not going to be, is very, very difficult at the site level to be managing those communications. And it definitely, the conveyance to the patient and to the physician is that we are not part of the team, we’re outside of the team.

Joseph Kim:
Yeah, that’s, I mean, to go back to centricity is not about centricity, but being part of a team, you know, in all management circles, high-performing teams, quote-unquote, one of the hallmarks of it is transparency. And if you cannot be transparent among your teammates, you cannot have a high-performing team. Full stop, right, full stop. So, yeah.

Jennifer Byrne:
Hundred percent. I mean, research is a team sport. It’s a team sport. Now, you and I have probably had this conversation, but I guess for the sake of the audience, I do think that it’s challenging because in the regulatory environment still, I mean, I think we’re still very much in a 20th-century regulatory framework versus the 21st century, and so I’m going to pivot on the healthcare side of things. Healthcare in today’s world is a team sport. In the 1900s, it was much more of an individual sport, individual physician, self-employed, you know, smaller groups. Healthcare shifted now, and so this whole notion around one physician having the ultimate responsibility for oversight of the trial, I think is a root and cause, blocker, and barrier to why we cannot advance having more people participate in research. You know, healthcare is shifting to more of an institutional team sport, and we’ve got to bring alignment on both sides.

Joseph Kim:
And because healthcare is fragmented, I don’t mean that in a bad way because it’s the team sport, research can’t come in and demand that be an individual contributor again because they’re, the context is a team context. So it gets awkward to reconcile those two and to orchestrate all the different people in the healthcare team to be part of this research gets really hard, I imagine. I mean, I’ve been in a couple of research studies myself and I always remember the study coordinator having to go find somebody to do the other thing and then, well, wait, wait, let me find this other person, she’s going to do this thing. And it’s very much a team sport versus maybe the 1980s or 90s where one person was sort of doing everything. Maybe the physician would come in and do a couple of things, and so you got two-person, but this was a full team, each doing one little piece of the research, because that’s how it is in healthcare, right?

Jennifer Byrne:
Yeah, well and I think even moving that upstream, even ahead of the individual study conduct, that is why kind of at the heart of, in Javara’s case, our integrated research organization model. While individual physicians and building physicians and pivoting those physicians to being high-performing investigators, our starting point is not there. We understand those individuals are central, right? Especially from a regulatory framework. One physician ultimately is principal investigator, small group principal investigator, … investigator, that’s great, but we’re actually moving that way upstream so that we’re ensuring that the institution that in many cases employs those physicians are fully supportive of those physicians’ activities. And in today’s world, and this is where I think pharma still is not always tracking, there’s still this pursuit of approaching an individual physician, Do you have this patient population? Well, yes, I have this patient population, will you have this patient population available to us for trial, you know, for those patients that qualify? Well, of course, I will. Well, from an institutional standpoint, that physician is very, very limited in terms of their ability to really access and broaden the pool of access for patients. And then you couple that with, at times, and in my experience, I see this often, pharma mislabels a trial. So pharma will label the trial as this is a trial that requires a board-certified cardiologist. So we’re going to the board-certified cardiologist who says, well, yes, of course, I have these patients. But through those inclusion and exclusion points, the reality is, yes, it is true that at one time that board-certified cardiologist took care of that patient or diagnosed or evaluated them, but that patient now sits in another part of the system or maybe outside of the system and is being followed by internal medicine. So right there you’ve got this channel conflict. So, you know, from the Integrated Research Organization model, you are getting buy-in at the system level, and that’s where that commitment, that clinical research will be on the menu of options for all patients, you are democratizing access across the institution as opposed to, and kind of busting down those silos in a way, right? You’re able to connect some of that piping.

Joseph Kim:
Yeah, and to your point, because the institutions involved, they can activate any other healthcare providers who may be on that, the journey of the patient, so it’s not just one person who needs to find that patient that they saw five years ago, yeah. Jennifer, that’s been such an amazing, like, eye-opening, it’s been great to see Javara advance through the short years it’s been around, and I expect it to continue to grow. You’ve given us a lot to think about the difference between healthcare and research and the patient-centricity as part of a high-performing team, the difficulty it takes to care for patients when you don’t have insight into what the research is making you do or not do. Leave us with one last thought about what makes your job still so difficult that, you know, you think, Gosh, if this could just change, everyone would just have an easier time running research.

Jennifer Byrne:
I think one challenge right now is, for a lot of the issues that we’ve discussed, complexity at a protocol level, complexity at a system level. The skill set of the research team is changing and is evolving. So, you know, on one hand, especially in the intersection of research with care and care with research, the phenotype of those individuals is very special and very unique. So I think that, you know, a call to action I think is widespread. I think that health systems, I think that pharma, I think really, you know, on all sides, we need to be elevating the awareness of the changing skill set of our workforce.

Joseph Kim:
While also keeping in mind that they’re always caring for patients in some way. We’re looking for unicorns, it sounds like.

Jennifer Byrne:
But I think that there are I mean, one of the, I think, really most rewarding aspects of what we are doing and what we’re in the midst of right now is we, historically, we’ve called this sector of the workforce research coordinators, we very deliberately have a different name for our, the mainstay, what I always refer to as the heartbeat at Javara, and those are clinical trial navigators. And I think that navigation piece of it does start to convey that responsibility that we have to ensure that individuals who are participating in research that that experience conveys in a real 360-degree way. So being fundamentally as concerned about not only bringing a person into a trial, but that what that means for that individual coming out of the trial and the responsibility that we have to the individual, to the healthcare system, to their team, in ensuring that we are not eroding trust in that process.

Joseph Kim:
Well, working for ProofPilot as an employee, I love the navigator term because it buys into that aviation metaphor, but yeah, I think it’s much more than coordination and navigation, just elevates that journey beyond just the protocol itself, I love it. So, Jennifer, as you’ve seen CRAACO grow this movement and, you know, companies like yours, Javara, for those doctors who were not open to research before, like, how is that landing on them now that an institution is going to be like forcing research on them? Does that turn them off?

Jennifer Byrne:
Well, you know, I’m very proud to say the healthcare partners that we have, I think very much take an approach of respect and great deference to physicians. I mean, they see physicians as absolutely core and a precious asset and a precious relationship, which is maybe not 100% of the case, but we’ve been very fortunate, I think, that physicians are not commodities within healthcare organizations. And it’s interesting, early on in our journey, I think that our earlier adopter healthcare partners very much were drawn to the value proposition of clinical research, to all the things we’ve talked about, the opportunity for addressing unmet needs for patients. An unintended consequence, I think that we have seen emerge and continues to grow, is that these healthcare partners now, when they see, for example, through data, but also even just anecdotal commentary that’s coming back, that patients love participating in clinical research. Well, when patients love their experience, their healthcare experience, Superman is the physician, right? It’s the physician and it’s the care team around the physician. So it’s interesting now because I think that, again, within our healthcare partners, they are now actively using this robust, trusted clinical research program that they have as a way of attracting. They see it as a way to differentiate within their markets or against their competitors. If all other things are kind of equal, having an opportunity for there to be kind of this research service offering to physicians, they are using that as a physician attraction and retention strategy. How wonderful is that?

Joseph Kim:
That’s just exactly the opposite of why you sort of invented CRAACO in the first place, it’s amazing, to come full circle and to have those doctors do a 180 and be attracted because of research, it’s great.

Jennifer Byrne:
And, you know, and that’s what has to continue to keep us on our toes. I mean, but we’re four years into this, we have about 150 active physicians working now as principal investigators. I’m super proud of that because for the most part, probably 95% of those physicians four years ago had never participated in research, so I’m really happy about that. But of the 150 physicians, there has only been one physician so far who has opted out.

Joseph Kim:
Huh? Well, that person’s missing out on a lot, I think. Missing out on the party for sure. Jennifer, it’s been great spending time with you. Thank you so much for being here. And yeah, I’ll keep, I’ll see you soon at a conference, I hope, and certainly, keep my eye on Javara and watch your success.

Jennifer Byrne:
I’m counting on seeing you soon, Joe, and I just want to thank you for all the ways in which you have raised the bar for so many of us across the industry, and your always willingness to ask the harder questions.

Joseph Kim:
Thank you for tuning into 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 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. This show was presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • Javara has about 150 active physicians working now as principal investigators, 95% of which had never participated in clinical research four years ago.
  • An IRO is an integrated research organization, where “integration” means partnering and building long-term relationships with other healthcare organizations, and using technology-enabled services delivery models within them to bring clinical research as an option available for all patients.
  • CRAACO is an acronym that stands for the concept: Clinical Research As A Care Option.
  • Patient-centricity is not just about sharing the data with the patient, it’s making sure that what’s happening with the them during the trial is easily available to the entirety of the care community around. 
  • Including the patients as part of the research team will give them a holistic view on the data collected.
  • Transparency is really important for clinical trials and has become an issue for ground-level management.

Resources:

  • Connect with and follow Jennifer Byrne on LinkedIn.
  • Follow Javara on LinkedIn.
  • Discover the Javara 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.
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