Breakthrough Strategies: How Design Thinking Can Shape Clinical Research

Leigh Burgess, CEO and founder of Bold Industries Group, reveals how applying design thinking can transform clinical research operations. Learn how radical prioritization and the innovative D90 framework can help organizations cut through complexity, enhance teamwork, and accelerate trial results — delivering more efficient outcomes for patients and stakeholders alike.

Transcript

Jimmy Bechtel: 0:01

Greetings and thank you for being part of the Society for Clinical Research Sites for SCRS Talks. I'm your host, Jimmy Bechtel, the Vice President of Site Engagement with the Society. Get ready to dive into pressing clinical research industry topics, celebrate noteworthy achievements and create a deeper connection within the research community. This is a space to amplify voices and perspectives that shape the landscape of clinical research. Today, I have Leigh Burgess, the CEO and founder of Bold Industries Group, here to talk with us around improving clinical research operations, some methods that we can employ within our organizations to do so like design thinking, and prioritizing improvement and innovation. Leigh, it's great to have you, really excited to talk about this subject with you today. But before we jump in, if you wouldn't mind, I'd love to learn a little bit more about you, your background, and a little bit more about Bold Industries Group.

Leigh Burgess: 0:57

Sure. Thank you for having me. I appreciate it. I'm Leigh Burgess and for the majority of my career, up until four years ago, I served really as an operations lead in large academics, so I worked at Duke. I was the chief research operations officer for the Duke Cancer Institute and then had the opportunity to come to Dartmouth and help them with their research operations as well. So, pretty much an operations person through and through and started as a project manager at Duke, but before then had lots of experience in health care as well as education, so this unique connection between both. And meeting education, I was actually in the K through 12 environment for 4 years where I helped teachers in the classroom actually understand how to use their testing data. So to make data actionable, which I think that's where my love of data and using that in my operational world and across my teams at the large academics that I've worked was really, really helpful. So, 4 years ago, I got to a point, it was the middle of the pandemic, and I had really been running pretty hard and majority of my career. But I think lots of things got exacerbated during that time and I was experiencing what I would say, considerable burnout. And I actually quit my job without having a plan and rolled myself into a space where I could, you know, think about what could I be, what could I do next, what am I good at and really doing that introspection. I started my own consulting company. Along with other things that I do, but really that's where I started and working with biotechs, pharma, and academics to help with innovative efforts or to help turn things around or implement or help leaders understand how to be bold in their actions. And really, that was my big swing of bold was leaving that world that I had been in, grown up in the majority of my career, and then creating a model to work with those that wanted to move fast, wanted to move agilely, and wanted to do in a process way of a process formatted way, and so creating frameworks and pieces and parts of that to help organizations and individuals be bold in their actions organizationally and individually

Jimmy Bechtel: 3:06

That's great, Leigh. And what's really cool is. It's a direct kind of culmination really of your background and some of the things you've done, right, not only through the education space, but also through some of the operations work that you had done at the research center. So that's, that's really, really cool. And frankly, a little bit inspirational I'm sure for a lot of people listening to kind of, do what you're good at and do what you're passionate about and find a way to make that happen. So thanks for sharing some of that background. You talked about Bold Industries Group as kind of this consultancy here to improve operations in a variety of different spaces, but how do you work, I guess, to create measures that matter most for research operations. You talked about that data driven approach and the operational efficiency. So if you could talk a little bit about that, that'd be great.

Leigh Burgess: 3:54

Sure. Yeah. I think in research operations, we have kind of maybe our top 10 or top five that we use, and you could use across any organization and any type, whether it's pharma or whether it's an academic or maybe a smaller research center. You're gonna look at things like, how long does it take to actually get the study started. What are my financials on the study? Are we breaking even? Or what's the efficiency cost of potentially doing this particular study? A lot of focus on time to open and first patient. I think what I was usually doing and continue to do with organizations is what are the ones that you need, particularly for your organization and how do you prioritize those to the top? So, I think, in the sense of time to open and first patient on, I do think those are continually going to be ones that are super helpful, but it's the sub-measures below that that are important so when we think of time to open, that's going to really be connected to how many people do you have on your team? What is the priority of this particular study? So, for example, at the organizations I worked in, which had lots of studies at any point in time wanting to open, but I have a finite amount of people. So what we needed to do was radically prioritize in the sense of how are they going to go through the process of opening, which if you, you know, you understand this, Jimmy, but a lot of people who know this too, there's a lot of handoffs and just like in the medical environment when you have more handoffs, the idea that something could go wrong happens. So, trying to think about, literally, this is an example of a metric that matters is how many handoffs are happening to your particular clinical trial just in that 1 metric line of time to open. So, from team to PI, PI to team, to finance, to regulatory, to IRB, back again, you know, think of all the different handoffs. So, that's an example of something that I think is important to measure, but isn't one that you typically see in a dashboard or in an OKI. So, in thinking about those types of things, really wondering what your sub-measures are within these larger metrics that we're always measuring in research operations. And that's just one example.

Jimmy Bechtel: 6:07

That's great. Leigh. And what I think is really important about what you just said is that focus on the many different parts and pieces that come into that, right? The different interactions that you have and, and how you need to kind of assess that and break it down and understand that, and everyone wants to get to the metric itself, but if you don't understand the process to get to that metric and to get that information or that data, then you're going to have a hard time really accurately assessing what its impact will be ultimately having gathered that and the work that it takes to gather that metric. Right?

Leigh Burgess: 6:39

Yeah, it's the story behind the metric, which I don't think we spend a lot of time on. We look at the metric and we say, okay, it took 180 days to open this study. That's terrible. Okay. Well, there's always a story behind it.

Jimmy Bechtel: 6:50

Right?

Leigh Burgess: 6:50

So, you know, when I was at Duke, that was something that was very, very important. But then kind of digging below that and seeing some of the gaps in staffing or the lack of prioritization across disease groups, or maybe not having a formalized way from a clinical trials management system to actually move things through the system, which, you know, I've been doing this a very long time, over 25 years. I've seen where we have a folder. And you walk around and get signatures. I mean, that's how old I am. So in the sense of that, there's always a story, but I think we don't dig into the story too much. And then what happens is we get into this continual cycle of doing the same thing over and over and we're getting the same results in some of the organizations, or we feel like we can't step out and be bold and do something different because, oh, that's not guaranteed success, or that might not work, or it might take investment, or, you know, insert whatever the excuse may be. But I think that's where we can get excited about the possibility of what could we do differently. And that's where I think design thinking came in to how I operated at the academics I worked in, but also kind of taking in the layer of the framework I created, which is, you know, the bold framework, which is believe, own, learn and design, which really, if you juxtapose it against design thinking, they definitely cross over. And so I think it's really helpful again, I'm always someone that wants to be like, that innovative agitator out there, you know, how could we do it better? How could we do it at a higher level of quality? And how could we do it potentially faster? And maybe how could we even do it at a lower cost? Those are things that are always come swirling in my mind when I'm working across the team, but also realizing that the people are what makes that happen. And so that story behind the metrics is really, really important to dig into.

Jimmy Bechtel: 8:37

I couldn't agree more. Absolutely. So, then we've identified these challenges, right? We've gone through some of the processes that you've outlined and worked through some of this together. So what are some ways to prioritize improvement efforts across these teams?

Leigh Burgess: 8:53

So I think that's where you look for where is the biggest bottleneck or where potentially has something not been paid attention to for a very long time. Right, so I think that's also something that can get stuck in a rut meaning that, you know, this is the staffing we've always had, or this is the max that we can do, or this is impossible because. So, if you hear those statements in your organization, there are things that you can then have that conversation. So I think"help me understand" is one of those ones when it comes to prioritizing your improvement efforts is like, help me understand why we couldn't invest in this. Help me understand why we couldn't move Leigh from the finance team to working in contracts. Or maybe Leigh will now be maybe the lead for everything coming into the funnel for how we're going to operate. So I think thinking outside the box again, which I think lots of organizations do, but do they value it is one of the things. Certainly the organizations that I worked at certainly value the thinking outside the box and wanting to be innovative, and I think, it all comes down to me ultimately, which, you know this Jimmy, like, why are we doing what we're doing? It's about the patients. So we need to understand what are the needs of the patients and the stakeholders. And to me, that drives where we need to go. So from the particulars of the organizations I worked across, every group had a priority, right? So it could be 13 departments. It could be 13 disease based groups within one area like cancer, but how do you prioritize? So, I think coming into that really goes down to really understanding what are the studies that need to be launched and how are you going to do that within your organization with regard to the priorities of the organization? Because there is not one size fits all when it comes to that. It is personal. It is curated by the organizations that you're working in. We asked PIs to prioritize their studies and if they had 5 that they wanted to open, they needed to put them in 1 2 3 4 5 order. We received, from one of the disease based groups, all number 1s. They had 5 number ones, so it can't work like that. Right? So it's then having that conversation of being able to understand when you're prioritizing your improvement efforts, or how you're going to move the studies through the funnel is what are the needs of our patients? What are the needs of also our partners? So, when we think about that, as working with pharma and biotechs, like, how do we bring those all together? And that's really where I think leadership comes into place of being able to prioritize, to being able to understand and define the problem and how they're going to move it through, and then be able to understand in the sense of are there ways or ideas or perspectives where we can tackle two things at once? For example, we always would have assigned individuals for finance and everyone's going to review finances of their particular studies. And it's usually one that can get sticky in the process. And so being able to understand how do I have more people in one particular team that has a higher level of studies coming through? So operationally, I would need to make sure that I was staffing up or making sure that I was being able to flex staff to help with volume coming through. So again, those are operational moves that connect to your priorities and the efforts that you're moving through the pipeline of the studies that are about to launch. And then once they're open, being able to measure when are we having our first patient on study, and that's not one to be missed as you continually move the studies through.

Jimmy Bechtel: 12:17

Thanks for sharing those examples, Leigh. And what I think is important as you gave those examples was that concept, we talk about it all the time. And right. It's like, think outside the box and it's not always easy for everyone. You know, a lot of people have, obviously, people have a hard time thinking outside the box. But it just means, like, remove the constraints that you have around the way that, you had so adequately put right at the beginning, around the way that you have been doing things. Just because you have been doing something that way doesn't mean you need to keep doing it that way. So kind of use your people, use your team and use what matters. Use, like you said, that priority to help you remove the walls from that square from that box and find a different way of doing things and try to come up with alternatives and test those alternatives. Which kind of leads me to my next question, which is a kind of method, a way for us to be able to do that kind of systematically. So how do you use things like design thinking or iterative problem solving and finding those solutions?

Leigh Burgess: 13:25

So this is where I overlaid the framework from my experience with design thinking and then created a consulting model called the D90. So the D90 takes that radical prioritization, so the D is"designed" and the 90 is"90 days." So when I go in and work with organizations, we are doing a 90 day strategic sprint. And that is something for them to see what we can do in that period of time, but it also forces us to radically prioritize what we want to accomplish because sometimes we can give our teams way too much to accomplish and it becomes very difficult to do front burner, back burner types of things. So, the 5 stages of design thinking are empathize, define, ideate, prototype and test. So when we think about that, what I do is I overlay the believe, own, learn, design. So with emphasizing, so again, I go back to what are our beliefs? How is our team believing in the importance and the impact of the work? Are they valued? Do we, do they have a mindset of innovation? Do they have a growth mindset? Are they stuck in fixed mindset zone? Right? And are the objectives clear for them of what success looks like? Because that is really, really important for their beliefs and understanding. So then we go in the design thinking process with define, which I will overlay,"O." So clearly defining and understanding the process of finding the solutions. You know, one of the biggest things I always wanted to do within my teams was enable them and encourage them to try things and fail, meaning that everything isn't always guaranteed. And I don't mean hurting anyone or any type of safety issue. What I mean is, like, we can try something. And we can understand is it going to work and how, but we're going to learn. So I think that's really, really important when we think about ownership of a solution. I think also ownership, which sometimes I think is hard, but making sure we each own what our piece of the puzzle is and not trying to own everybody's piece. And I'm certainly at fault of that in the time that I was in those roles of just trying to pick up the pieces where things were falling and help out. And I think that's important, but making sure you're knocking it out of the park and what you own in this process. And then being accountable and having the responsibilities to do that. Then we come into ideate, I love this part, which is brainstorming and learning and looking at all the different perspectives. And, that really is where the"L" of bold comes in continuous improvement and getting feedback groups, but we don't want to do is do the same thing over and over and have cyclical dysfunction in research operations. So making sure we stay open to new information and being able to pivot and that's really the ideation and learning. And so then we come into prototyping or where I would say design and we're creating the idea of what can we do differently? Or is there something that we can do from a process perspective that can help us achieve our goals? And then again, going back to remembering what our beliefs told us about how are we measuring success and our outcomes? And how are you including others and stakeholders and understanding what is the mission of what we're trying to accomplish? So, that's really empathize, define, ideate, and prototype and then we get into the testing, which is really the iteration of just continually testing and refining what you're doing and knowing it isn't just a one size fits all because staff could go on vacation or staff could resign, or maybe you have a new PI coming in, which is a whole, another bailiwick of how do we approach this and understanding those needs and and across these disease areas, and isn't just one group that you're working with. So, continually testing and refining what you're doing and then integrating that back into the process is key. So that's what we do in the D90 and it's a pretty fast agile pace. Which that's another piece and part of of design thinking that I think really comes into it is like we're not waiting around for months or weeks to figure out if it's working or not..

Jimmy Bechtel: 17:05

Thanks, Leigh. What I really like about what you just explained is it kind of goes back to the point that I made earlier. It takes what truly is generally an arbitrary process and we've worked through and identified our challenge and we know where we need to go, right? We've done these things, we've prioritized the improvement or whatever, but then it's like, how do you get to that next stage is again, kind of this arbitrary process. And not a lot of people understand. We're not really fully trained or educated on the path that we should take to then implement that solution and actually institute long term change within our organization and the mechanisms in place to test it, right? It's hard for people. So what I really liked about your explanation was this process. It's methodized in that there's a clear path that we can walk with steps that we can grab onto. They're tangible. I can move from one to the next, and it helps me wrap my head around how we get from problem slash challenge to effective long term solution that actually does some of those things that you talked about around building efficiencies in how we execute our clinical trials, ultimately then improving things, improving outcomes for patients. That's really the end goal for everybody here. So it's cool to hear someone like you has put time into kind of methodizing what we're doing here to solve some of our challenges.

Leigh Burgess: 18:30

Yeah, what I want to do is like, how did I do what I did at these large academics and then how can I scale that so that more organizations can use it? And also, I think there was a real awakening for me. I'm an operation site based person, total loyalty to that and understanding of it because I experienced it. And that's really where I live the majority of my career and in the corporate side. But I think what was so interesting when I started doing the larger pieces of consulting and seeing kind of how the CRO was involved and how the sponsor was involved and then potentially the sites. It was another way to scale this perspective, because I had done this all along in sites, but now I could do it across the whole system and the processes. And you begin to see some of the pain points within the CROs and within the sponsor side that they need to work on as well. It's a group project. This is not just totally We learned this in high school, right? And you first when you do you're like man this I don't know if I like this or not, but that's what this is. And so that's what underscored for me in that process It's like these are things that we can all use when we're thinking about improvement and everyone has to be open that there's something that they could do better. And there's something that they can learn and I think that's a key piece to the mindset that also goes into whether it's design thinking or the overlay of the BOLD framework that you have to be open that something could improve, that something could be better that it just isn't the bees knees right now and nothing nothing needs change.

Jimmy Bechtel: 19:59

That's a great point, Leigh. So as we start to end our conversation here, I do want to ask how is this new way or modern way, we'll say, of consulting and process improvements impacting not only small, but large organizations as well. What's ultimately the outcome that you're seeing or that is being realized by these organizations.

Leigh Burgess: 20:25

Definite things I've seen over the last 4 years of using this model is that one, we are seeing the results happen faster. We are seeing studies open. We are seeing us achieve our enrollment goals faster. And again, that group project mentality is super helpful in honing the communication and how we talk and what we communicate and the data that we're looking at along the way is so important. So sometimes we have data overload. So I think prioritizing the key data metrics at the front end of a study and then knowing that you can correct daily if you need to, is really something that's different with regard to the model that I use. I think with that you have the opportunity to do the D90 in a particular different area of the organization. So, you could potentially work in finance, or you could work in operations, or you could work with the IRB and think about the breakdowns or maybe areas where you just know it's getting sticky right there, I just want to look into that. And it's this deep dive that can happen pretty quickly. And then we go through the process and within the first 30 days, we've identified areas and we're already working on what could be improved. So we're able to measure pretty regularly and fairly quickly if we're improving. So it's impacted small and large organizations to be able to open studies, to get patients on study, and to actually reach their enrollment goals faster than they ever did before. Because it kind of spins out of this way of doing things, which is like: Step one, step two, get approval, have a meeting, have another meeting, have a meeting, have another meeting. Okay. Step three. It was like meeting mania and approvals and things like that, and I'm not saying just go rogue, but I'm saying you have agreement up front to actually lead and move and direct and get things done that you just normally don't have in some of the settings that we work in.

Jimmy Bechtel: 22:19

Another excellent point, Leigh. And I think what's really important here is ultimately, big or small, like you stated, we're improving our ability to reach enrollment faster, and ultimately then bring the medicines to patients faster. And that's what we're...

Leigh Burgess: 22:36

That's the whole point!

Jimmy Bechtel: 22:37

...truly all in this for, right? Exactly. That's what we're all in this for so if we can find ways to be able to do that when we've identified some of these inefficiencies within our organizations, then truly everybody wins. So Leigh, thank you so much for the conversation today. Thank you for sharing a little bit of your secret sauce and some of your insights around what you do and as an expert in this field, what some things that we might think about as organizations in this space and then how we might approach some of our problem identification and problem solving ultimately, because that's what we're all about is finding those solutions together. So again, thank you for being here today, and thank you for sharing those insights.

Leigh Burgess: 23:16

Absolutely. Thank you for having me.

Jimmy Bechtel: 23:20

As we conclude, for those listening, don't forget to explore other site focused resources made available to you, like various publications and webinars on our website, myscrs. org. You'll also find a wealth of content and details around our upcoming engagement opportunities, like our Site Solutions Summits being held throughout the year. Thank you again for listening. And until next time.