Fixing the Foundations of Clinical Trial Execution

Jimmy Bechtel sits down with Dr. Tia Warrick, CEO of Lesous Consulting, to talk about what actually drives clinical trial failures and what the industry can do about it. With nearly a decade of experience spanning coordinator to CEO, Dr. Warrick brings a ground-level perspective to a problem that costs the industry billions.

The conversation covers why so many trials struggle before enrollment even begins, the difference between foundational certifications and true skills-based competency, and what it means that roughly a third of clinical trial failures trace back to workforce gaps we actually have the power to fix. Dr. Warrick also shares her take on where AI fits in, and why it is a useful tool but not a replacement for people who truly know their roles.

If your team is thinking about how to build a more resilient, capable workforce and set trials up for success from day one, this episode is worth your time.

Transcript

Jimmy Bechtel 0:00

Hello and welcome to SCRS Talks provided by the Society for Clinical Research Sites. I'm Jimmy Bechtel, the chief site success officer with the society, and today I'm joined by Dr. Tia Warrick, who is the chief executive officer with Lesous Consulting, here to talk with us about how we think about and approach and maybe fix some of the foundational challenges we have with clinical trial execution. Before we get into that exciting topic, Dr. Warrick, I'd love to hear a little bit more about you and your background before we jump in.

Tia Warrick 0:35

Thank you so much for the introduction. Hi, everyone. I'm Dr. Tia Warrick. I am the chief executive officer of, Lesous Consulting. I have nearly a decade experience working in the clinical research industry. I started as a clinical research coordinator, and I worked my way up. I was a clinical research associate, overseeing data at sites, and then I was a clinical trial manager, a project manager, global project manager, and now a CEO. And I'm so excited to talk about, all the amazing topics we're gonna be discussing today and, really excited to give some great tips about clinical research and some of the efficiencies that I think would be great moving forward in the industry.

Jimmy Bechtel 1:17

Yeah, I'm excited as well, Dr. Warrick. So let's jump in here and talk a little bit about this time of clinical research, this stage of clinical research kind of before enrollment even begins. and maybe share your perspective on why do so many trials struggle at that stage, right? What early kind of operational issues that we often see are overlooked?

Tia Warrick 1:40

I think that, it could be many reasons depending on, you know, who you're working with, the site, the location, the region. But it all boils down to three very common things. the number one thing is experience, the second thing is resourcing, and the third thing is, really having unrealistic expectations. When you set yourself up for failure, more than likely you will fail. And so this is one of the things that I, discuss a lot with pharma companies and CROs, that it's really important to set yourself up for success and be realistic about what is actually possible. there's nothing wrong with, achieving or even setting a goal to reach, that is great to meet that deadline and to have an endpoint in sight, but we have to make sure that that goal is realistic and has that middle ground that it may be a little bit aggressive, but it is achievable. And oftentimes we see that these particular timelines or operational, expectations are not only aggressive, it's also non-realistic. So when you couple those two things together, you have a high rate of failure, and dissatisfaction across the board. so those are the three aspects that I think, are where people, overlook the most, and it leads to the overall, complexity of operational oversight

Jimmy Bechtel 2:53

I recognize those things as well. I mean, talking to that, the concept of setting realistic and effective goals and expectations I know we're gonna talk a lot about this, and how we manage doing that together collaboratively. But that applies across the board. not only To the sponsors and CROs, but also to our service providers and our technology companies that we're leveraging or working with on the trial, but also with the sites themselves. and maybe even in some instances, the patients, right? Some people are very goal-oriented, and if we, bring them along with us on that clinical trial process and help them understand what the goals of that study are and what the goals of their involvement might be, that also is an area where we want to, as you put it, set everyone up for success and be realistic in that space. So Dr. Warrick then, how can sites and sponsors and CROs work a little bit more effectively to build stronger partnerships that improve in these areas that are so critical? Things like communication, the feasibility, the startup, the enrollment process, and trial execution ultimately

Tia Warrick 3:51

So some of the things that can ultimately, be successful towards trial execution, for me, like I said, is having an experienced team. You can have all of the resources in the world, but if they are not experienced in the way that they need to to be successful, then, there's going to be missed things or things that may have been-- that should have been planned that wasn't. And it's not to state that we shouldn't give people who don't have experience a chance. I actually believe the opposite. I think we should, give everybody a chance who is willing to learn. And so it goes back to the foundational thought of what experience is and how do we define that, right? So experience is if somebody's in a job for a certain amount of years, then they must be experienced. in that job, and even in being in that role for those amount of years does not mean that they're experienced in every aspect of the role. It doesn't even mean that they had an opportunity to be exposed to many aspects of the job, even though it's a part of the job description. And so it leaves a lot of room for misinterpretation and gaps when we're just looking at, numbers on a paper and not necessarily looking at skills-based competencies, right? So I challenge the thought of what it means to be experienced, and I think that, you know, when I took a second to think about what that means, to me, it's skills. Do you have the skills to execute the role or the function, to achieve that overall goal for operational efficiencies? And oftentimes, you know, again, people are in the role, they're doing the job, but the skills are still lacking. And so skills-based competency is a really big thing, that, people should learn. And it's not just knowing ICH and GCP. That's very important. That's foundational competencies, right? But it doesn't help you necessarily do the minute aspects of the job. For example, if you're a clinical research coordinator, knowing the foundational information about ICH GCP guidelines is very important. But how to then translate it into application in your everyday role, that is what is a huge gap, that, many people struggle with. And so for me, I think that really focusing and shifting our focus to skills-based competency learning is really gonna help with those operational, gaps and efficiencies

Jimmy Bechtel 6:09

I wanna dive into that a little bit deeper, Dr. Warrick, and kinda tease out some of the things that you mentioned there. Skills-based competency, is really important for research professionals and that concept applies to a lot of other industries and spaces as well. So can you talk about maybe a little bit more on what that means and why it's important and with that, how it differs from traditional sort of certification or certificate or kind of checkbox, if you will focused preparation?

Tia Warrick 6:40

Great question. So for me, skills-based competency learning, and I can give a great example. So, if we're discussing, back to the clinical research coordinator aspect, 'cause clinical research coordinators are one of the biggest gaps that's rising. we, for every three trials, we only have one coordinator, right? And, it's becoming more and more of a resourcing issue. There is another company starting every day with a new pipeline and a new treatment going to sites, and they really need to work with these sites, and some sites don't have the capacity, nor do they have the resourcing. And if they do have the resourcing, the resources are not necessarily fully experienced in the roles, right? So, for clinical research coordinators, me starting off as a clinical research coordinator, it's the role where I was introduced into the indust-industry, and forever grateful for that because I love this industry, and I think that it's phenomenal. one of the things that I learned is that, for example, the first thing that you do on the job is you have to do your CITI training, and you have to, make sure you understand the Declaration of Helsinki. You have to understand ethics, right? The code of ethics. You have to learn about the ICH GCP guidelines, other regulatory aspects depending on what countries you're working in on that trial, and all of those are important. All of that is information, right? So then how do you take that information and translate it? So you have organizations like SOCRA, you have organizations like APHA, and ACRP, who are absolutely amazing, and they provide a lot of, information and courses and things of that nature. Again, knowledge. And they test your knowledge, and you get the certification to say, "Yes, you are a professional," because you understand the knowledge of foundational aspects of what clinical research is and how to essentially be ethical in conducting clinical research. What it does not do is tell you as a clinical research coordinator, as a clinical research associate, as a clinical trial manager, how do you do your everyday job, right? You have the foundational knowledge, but how do you translate that knowledge into your specific role to make sure that you're executing what you're supposed to be doing at your level efficiently? And that is what they do not teach you in those certifications. And so those certifications, a hundred percent, they're so necessary. I'm certified in almost all of them and they're, they're needed to understand the foundational knowledge, but they are not, the end all be all to really bridge that gap to skills-based competency learning. So for skills-based competency learning, what that looks like is if I'm a clinical research coordinator, I'm gonna learn a specific skill, how to, execute an informed consent effect-effectively, right? What do I do? What are some of the things that I need to do while I'm in that room? Not, okay, I understand the ICH GCP guideline on, making sure that there's no bias and there's no this. I understand the information, but how does that now get translated to application? How do I effectively do that, right? And that is where the skills come in. And oftentimes it's through trial and error. you know, you really need to have specific training. A lot of the time it's left on sponsors, and every sponsor have their own preferences. So there's no real centralized way, and that's why we have all this variability in clinical research. And so, for me, it's how can we create simulations? How can we do these microorganism or mic-microenvironment of learning, to allow people to learn specific skills? So how can we simulate somebody learning in a safe learning environment how to do an effective informed consent with a patient, right? how to take that information and knowledge that they have and really translate it into something, that is effective, and application based. And that's really what skills-based competency is. How do I effectively enter data into electronic capture data system, right? How do I do that? every system is going to be different, but what is the basic knowledge of what are some of these skills that I need to know? Do I always need to make sure I check the units? I always need to make sure that they're sourced, right? All these specific, skills, you know the information, but again, it's that translation piece that's often missing

Jimmy Bechtel 10:42

Those are excellent points and a lot to unpack there, which is awesome. What I really heard is certificates and all-- they have a time, they have a place. They are great foundationally, but when we go to apply what we need to learn and understand so that it allows us to more effectively deliver patient care, that's where we get into enabling this concept of skills-based competencies and moving past, like I said earlier, just checking the box. Or, we have this, that, and this, that's great, but does that actually mean we can do what needs to be done to, again, assure the utmost highest level of patient care?

Tia Warrick 11:17

Absolutely.

Jimmy Bechtel 11:18

So what then, Dr. Warrick, what sort of gaps, right? we're talking a lot about skills here, leading us to a broader picture around workforce. what workforce gaps are, in your experience, affecting trial quality or timelines or I guess maybe overall performance at the site level?

Tia Warrick 11:36

And I think, again, not to, to bring it back, but of course, overall the gaps is the resourcing. Of course, there's not-- you know, there's more trials than there are coordinators right now. and so I think having, you know, enough resourcing and bringing more people in and ensuring that we're providing the appropriate training for people to stay in the industry. There's a lot of coordinators who start in the role and, they often want to, go on into working at CROs or maybe becoming CRAs, which is very difficult to do, or they burn out at that level, and they don't stay in that role. And I think the average lifespan for a coordinator on average, according to some research when I was looking at job outlook, it's basically two point two years. So every two years, a coordinator will burn out, they'll leave, they'll go somewhere else. It's very rare that you'll have a coordinator staying in a role for longer than that. And so not to say that they don't, but it's very rare, and it's because of the amount of pressure that's put at the coordinator level, at the entry level, right? And so, some of the things that we can do to kind of bridge those gaps is yes, that skills-based competency learning is not just, you know, to teach you those skills, but it's also to build resilience. If you feel confident that you know what you're doing in the role, you'll be efficient at doing it. And so you can then have increased capacity to handle more without burning out. And so it's not just, you know, learning the skill, but it's also building capacity and resilience. It's really important for bridging the gap, in the industry. And, and honestly, having that skills be increased will reduce a lot of the issues we see, at the CRO and sponsor level, right? Eighty percent of clinical trials fail 80%. So when you look at that 80% and really break down how much of it is contributed to what, you know, r- that kind of, compliance and competency and skills-based learning is a huge part of that. It's almost 30%, right? The other parts are budget, you know, sometimes funding just run out, right? and sometimes it's just the efficacy of the treatment just doesn't work. But just to know that a third of that is really towards, skills-based competency gaps is, it's really huge. And so for me, I thought, "Okay, what can we do?" We can't really do anything about money. It's either you have it or you don't, right? We can't really do anything about the treatment. it either it works or it doesn't, right? But we can do something about skills-based competency learning, and we can do something about building capacity and building efficiencies and having people feel empowered and prepared, in their role to be successful. When you set people up for success, they will be successful, right? So it's very important that we push beyond the novice of just information and really give people the skills they need to be competent in their role. And a lot of clinical research coordinators, even CRAs, they're often from other industries, or they often-- they don't have a lot of background in clinical research unless they're a nurse. And I know this because I was a clinical research coordinator, right? So I started knowing absolutely nothing and learned everything. And so working in all these roles in the industry and being in the industry this long, you know, it's just the way it works and, there's nothing wrong with that. But we can't have that kind of system without the support that it needs for it to be successful, and it does drive a lot of the reason why clinical trials fail, right? if they feel enabled and skilled in their role, it'll reduce a lot of the quality issues we find in trials. It'll reduce a lot of the data quality. That's the reason why when it goes to the FDA or a reg agency, it gets rejected because they tell you to go back to the drawing board, reopen the trial, get more patients because the data's not clean enough. And so there's a lot of things that, happens as a result of, not having those skills to really, prepare people to provide you the utmost quality that's needed to be able to conduct successful clinical research

Jimmy Bechtel 15:31

A lot of really great points there again, Dr. Warrick. I appreciate very much that you've, helped us ground this conversation and some of what you're talking about in data and seeing really just the impact that not having the skills necessary to do the work can have on the overall enterprise of clinical trial development, drug development, and execution. Imagine where we would be as an industry if that, even just that one-third that we really, like you said, we really do have control over, was, resolved, and we started to shift our focus into what that means and work together to solve that challenge. I think it's a, an excellent, area of potential focus for us as an industry so what does the future of research work development look like then? Especially when we look at the future and things we-- kind of the hot buzzwords here. When we talk about the technology and AI and operational complexity, as these things really continue to evolve, and in some places, in some instances even become more challenging.

Tia Warrick 16:32

Yeah. I think AI can be a great thing and not so great thing. It really depends, right? So, I see the industry evolving in the way that it decentralizes information and in the way that it enables people to gain those skills, right? Some of these skills may not have to be learned, because of AI. But knowing how to do the skills will enable you to have a better result with AI. AI is not the answer to everything. It hallucinates. You still have to know what you're doing. You'll have to know what to ask. You'll have to have that kind of basis anyways to be able to use it, right? And AI is not going to be a full replacement, at least not yet, right? We'll see what the future holds. But for right now, we're a ways off from it replacing and completely, taking over our industry specifically. I can't speak for other industries. I'm not an expert there. But for at least the pharma and clinical research industry, we have to verify, right? We need to check. We still have our CRAs going out to sites looking at data, right? We're not gonna have AI take over that anytime soon, right? When we're working with humans, and we're working with something as important as investigational drugs that's going in our bodies that has-- that can have huge, you know, cytotoxic effects on us and pharmacokinetic effects, you know, AI can't really replace that for a while. But like any other tool, it can be very useful in efficiencies, especially through operations. So how can we utilize and incorporate AI into, especially accelerating our skills? So if you are a clinical research coordinator or a CRA, and you need, you know, to gain a skill or, build efficiency on, you know, looking at this or finding something in a protocol, we're humans, we can have human error. Like, what if we miss something in a protocol? We can ask AI that, right? So AI can help us in a lot of different ways, but it's definitely not a replacement. and so I think it does add another layer of complexity. And if we use it right, and if we implement it in the right way, and we use it as a tool and not a replacement, I think it'll be more beneficial than not. so it-- we're at that pivotal time where we can make these decisions and determine the best way we can do it, and a lot of companies are doing that, right? They're having entire AI development and innovation departments where they're asking, "What is the best way we can use this?" Right? It's such a new thing. Can we make this, optimize for our benefit? And, I really think that there's a lot of promise there, but it doesn't replace the premise or even the problem that we have at the root is that we need people who are competent to know, how to do the role. And if they know how to do that, it almost makes it easier to use the AI because you'll know what to ask it. You'll know how to use it as a tool, instead of going to it for everything and just hoping that it can solve your problem. So I think that that's something we have to take some self-reflection on as an industry and continue to develop and learn about it and how we can implement it in our everyday lives. But it definitely shows promise.

Jimmy Bechtel 19:30

I couldn't agree more, Dr. Warrick. it's really important for us to ground ourselves in that reality and where we are today and what we should and should not or can and cannot be doing with the tools that we have available to us, AI being one of those. It's exciting, no doubt, right? But really just understand, what our limitations are, and we are in the business of patient care, and that's really important for us to remain grounded in as an industry. So again, thank you for those insights. But overall, you know, thank you for the conversation today, and thank you for, helping us maybe dive in or understand some of the ways in which we might solve some of our workforce-related challenges and fix some of the challenges and issues that we have, really before we even get into the clinical trial and see patients for that first time itself.

Tia Warrick 20:19

All right. Thank you so much. It was great speaking with you.

Jimmy Bechtel 20:21

And for those that are with us, make sure that you check out other site-focused resources, other podcasts like these, as well as opportunities to hear from patients, sites, and other industry partners on our website, myscrs.org. For those that are listening, thanks for tuning in, and until next time