Beyond The Protocol

When a Trial Saves Your Family

Melody Keel Season 2 Episode 3

Why Inclusion Must Be Intentional 

Clinical trials aren’t just about data, they’re about people.

For Denise N. Bronner, Ph.D., that truth became deeply personal when her father achieved remission thanks to a therapy approved through a clinical trial.

In this episode, Melody Keel sits down with Denise, founder of Empactful Ventures, LLC and a leader at the intersection of science, equity, and strategy, to explore why inclusion must be built into the core of clinical research, not added on as an afterthought.

What you’ll learn:
👉Why equitable trial design is essential, not optional, for real-world outcomes
👉How Denise operationalized DEI through data, dashboards, and site strategy
👉The emotional and systemic stakes of exclusion in research
👉How post-approval patient stories can uncover overlooked gaps in trial design

Whether you’re running a single trial or shaping global research, this episode shines a light on why equity isn’t optional, it’s essential for impact that truly lasts.

Make sure to subscribe on your favorite platform 🤍
And leave us a review ☺️

#ClinicalTrials  #DiversityInResearch #ClinicalOperations #InclusionMatters 

#BeyondTheProtocol

Welcome to Beyond the Protocol—where authentic conversations about clinical research happen.

Hosted by Melody Keel, bringing together diverse professionals from across the industry to share insights and experiences about what it really takes to deliver successful clinical trials.

This isn't about perfect processes—it's about real people sharing real solutions.

Let's go beyond the protocol.

That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials. 

If you found value in today's conversation, please subscribe, share with your network, and leave a review. 

Have experiences or insights to share? Reach out and be part of the conversation.

Join us next week as we continue to discover what lies beyond the protocol.

You can catch it on :

📺 LinkedIn Live

📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol

🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056

🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612

🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7

🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/

This Podcast is Sponsored by The Research Associate Group, Inc.

Melody Keel: All right. Welcome back to Beyond the Protocol, and I'm so excited to have my guest here with us. I have Denise Broner, who is the founder of Impactful Ventures and a leader in our industry. Um, I'm just gonna say you are the leader and your intersecting science, equity and strategy in impactful ways. So you're just 360 degree.

I love it and I'm super happy to welcome you to the show today. Yeah, 

Denise Bronner: no, thank you for having me. I mean, honestly, it's weird when you actually look back at all the areas that I get involved in. I'm like, my God, I'm in a lot of stuff. Right? But it makes sense. Like, you know, like most people looking, I go, well, how does this all mix in?

I'm like, it all makes sense. Just 

Melody Keel: together. It does. Yeah. And I was doing, I always like to do a little research on my guests and I, I noticed that you love Legos, and I was like, that is so. That is so spot on because I feel like even though, like you just said, you kind of have your hand in many things, they fit together and you're just building an empire over here.

So listen, I wanna dig into that today. 

Denise Bronner: Listen, Legos are my thing that I, that is like my pastime. And since I don't have kids, I'm like, I get to spend my money on crazy things. And I was going through and counting the number of sets that I have, and in one room alone, I have 10. And in other rooms, I'm like, I, I know there's at least another chance there's more.

There's 

Melody Keel: team. Oh yeah. I sold the Lego Dream. I have two, two boys, and both of them seem to be future engineers and they're all about Legos and the amount of money that I have invested. So I totally understand. It's a lot. A lot. So let, let's dig in. Um, I would love for you to just kind of introduce yourself and let's talk about your journey from kind of the bench over to clinical in, uh, innovation and, and our industry.

Denise Bronner: Oh man. So I am originally from Detroit, Michigan, so I'm a Midwest girl and I knew at the age of 14 that I wanted to get a PhD. So, and it was only because of, I had a black male science teacher who was teaching us about. You know, the microscopic world and to me I was like, wait a minute, you're telling me bacteria and viruses, something that you can't see can take down humans and some of the largest animals on, on this planet.

I was really intrigued that they could live in these very extreme areas. So I was like, this is, this is fascinating. And yet we still have some bacteria that are good to us that live in our gut. So that just blew my mind. And so I, you know, went in dipped my undergrad, you know, was able to join into, uh, the IMSD program where I did undergraduate research for years.

Melody Keel: Mm-hmm. 

Denise Bronner: And I applied to grad school, and I remember I didn't have much microbiology experience besides just a class. Um, and so when I applied to the microbiology and immunology program at University of Michigan, it was interesting that the, the committee who was reviewing applications said she doesn't have a lot of microbiology experience, so why should we bring her into the program?

Out of the incoming class, I had the most research experience he had ever seen. So they brought me in for an interview and that's when they saw how passionate I was. So did grad school. At the end of it, I didn't know what I wanted to do, but I didn't wanna become a professor. And so, but you know, they didn't really talk about careers outside of the ivory tower.

It was kind of taboo. Right. And they're like, if you go in the industry, you're going to the dark side. I was like, that doesn't sound too bad, but Right. Great. You know, I might make a little bit more money, but at the time I didn't really know. So I did an academic postdoc out at uc Davis, and that's when I got introduced to the world of business.

Through a business development fellowship. So they would take PhDs, PhD students and postdocs and bring them into the world of business through a few business classes. And that's what just blew my mind. 'cause I was like, wait a minute, wait a minute. You have a bunch of people who are going to business school, who are leading companies and investing in ideas and they have no scientific background, no science background.

Mm-hmm. It kind of concerned me. The idea that being a person with a PhD, that you can't really make that transition because you're too technical. You like the social skills. I was like, I gotta challenge that. So I did a, the big, the big Bang business competition came up with this idea of taking spent grain and turning into a, at nutritious snack, won all kinds of money.

And I said, if I can do it with this, I can do it. Yeah, I can do it. So I did a little bit of consulting 'cause that's like the easiest way of transitioning out of academia. I did that for a year. Worked on, you know, large pharma companies and their feasibility programs, helping 'em understand how to do better with site selection and patient identification.

And then ended up being headhunted by one of my clients, j and j. So I got pulled in at the height of the pandemic, which a lot of people were like, wait a minute, you changed in the height of the pandemic, why would you switch jobs? And I was like, I need to go And. Made that jump, worked in their feasibility center of excellence and then transitioned over to their DEI and clinical trials team, because when I was working on feasibility, we were looking at recruitment, you know, trends.

You're noticing things. You're noticing 

Melody Keel: things. Yeah. I'm like, I 

Denise Bronner: we're missing a lot of representation. Mm-hmm. So why, why are we not using data more effectively to find these types of patients and. I started working with the D-E-I-C-T team and they were like, wait, where's all this data coming from? I was like, it's from feasibility.

So create a whole framework on how these teams can work better together. Transitioned over to that role, and then from there, worked there for three years and completely changed the immunology portfolio from being maybe we would have some patients to being highly representative. I mean, our IBD studies had 35 to 40%.

Of non-white patients that's never been seen before. That's amazing. 

Melody Keel: Yeah. We 

Denise Bronner: did a hundred percent skin of color, uh, psoriasis trial. We had, um, you know, rheumatoid arthritis trials that were 30%, you know, representation of non-white. So we were really changing how things worked. Yeah. But I said, this is only one company.

Is there a way for me to do this across the industry and to work with more? Vendors, especially startups who are focused in this area and help them gain better, better access to pharma. Yes. So pivoted out did Impact ventures, and here I am a whole year later. 

Melody Keel: I love it. I love it. Um, it's amazing how we make this so difficult.

Um, and I have so many conversations and like you said, they were like, how'd you get the data? And I was like, it's right here. You have tons of data. You just don't use it in a way that would make sense to help. Yeah. Increase the representation in our trials. And, um, it's just, it's so many different sides to it.

Yeah. Um, but at the end of the day, it's still quite simple. It really is. It is. Yeah, it is. Yeah. So, all right. So I also wanna touch on, I, I know, um. It's just, it's just a theme for many of us representation and really advocating for that from the, from the perspective and viewpoint that each of us has. Um, and you don't have to be black American, you don't have to be brown.

Um, everyone should take this flag, right, and, and help this push, this advocacy forward because it matters if you're a true scientist and you care about. Humans, right? Yes. Then you, you pick this up and you carry it in the way that you know how. So I would love for you to share, um, a bit of the personal side of why clinical trials and representation matters, because I know you and your father had a journey where this was very impactful, right?

For, for the outcome for his journey. 

Denise Bronner: Oh, yeah. Yeah. It's interesting when you think about this, I feel like. It's very obvious that when the term DEI comes up, most people immediately think of race and ethnicity, and it's such a disservice because it's not just that, yes, we do have low representation of black, Hispanic, and Asian individuals in trials, but it's also looking at it by age, by comorbidities, all these different things that make a person who they are.

And it's sad that when a person goes to the doctor. The doctor's prescribing them something and they ask the doctor, well, how do you know that this will work for someone like me? And the doctor can't answer that question. They're like, well, you, right. And so when I think about my own dad, as he was going through his, his journey when he first was diagnosed with multiple myeloma, he didn't present in the classical sense.

Mm-hmm. So typically people are showing signs of, you know, the where, where. You're looking at this going, well, you know, okay, we might see, you know, some fatigue. You might see, you know, um, you know, there, if you're looking at certain blood results or blood panels, you're seeing certain things kind of spiking and things not, he wasn't showing that what he had shown was just congestive heart failure, and this was some man who was still in shape, who was just entering in early retirement and.

If you're looking at him and you're going, did this making sense? Why are you showing signs of congestive heart failure where he was having some, some water buildup and he was having shortness of breath and we went to the urgent care and they were like, dude, you have a lot of fluid in your chest cavity.

You need to go to the doctor. And I would never forget how the emergency room treated my dad. They were constantly asking him, well, you know, are you sure you didn't have a heart attack? But like, no, we know that for a fact. They're like, well, are you on any drugs? Because you know, it'll come up in the panels and I'm thinking, I'm sorry, the person just told you no.

And you keep asking three to four times. So when we finally got transitioned out of emergency care to the cardiology unit, that doctor I will never forget, Dr. Wanni really sat and listened to my dad and he says, I agree with you. Something just doesn't seem right, 'cause you're not showing signs of a heart, heart attack.

You're in shape. Right. I don't understand. He's like, I have some ideas, but I need to keep you here to do some, some tests. Yes. Yeah. And so we were in the hospital for a whole week, you know, so my dad had the whole gambit of, you know, a bone marrow biopsy. He had, you know, all kinds of scans and imaging done with different dyes, and it came back that, okay, you have multiple myeloma, and my dad's like, what is that?

So again, level of awareness. And the doctor went through and explained it, it's a blood cancer. You know, this is what typically happens, but you're not showing in the classical sense. So we are lucky to have found it when we did it's, but it has done some damage to your heart. So now we had to go through the process of going through chemo and of course it's a standard, you know, regimen of chemo and he went into remission.

But then COVID hit. And so you can't really go to the hospital to go get your blood work done because it's taken over by COVID. So a few years went by a couple years and then we went back to do a checkup. It had come back again. He hit relapse. So, but now it was on the market was a new drug called Darzalex.

And so we were like, oh, this is cool. Yeah. Um, and. They had a new VER version of it where you could do just a simple injection and not have to do iv. 

Melody Keel: Right. And 

Denise Bronner: I was talking to his oncologist at the time and I said, I, I don't want him to do the IV or infusion because that's a lot of fluid that's gonna be putting on him.

And his heart is already in a, in advanced state. And the doctor's like, I agree with you, but I have to deal with insurance. So, but when we were talking to him, I was like, well, how do you know it's gonna work for someone like him? And he was like. I only have one other patient who has an advanced stage of congestive heart failure, like your father, but he's an old white guy who's in his eighties.

So there wasn't even data in the trial that reflected patients of my dad's race. Of his. There were some of his age, but not with the comorbidity that he had of congestive heart failure. So this was where we were going in, and the doctor was like, I have to tell you when you go on it. You have to tell me how this makes you feel.

He says, I'm not. He's like, so if it's not making you feel great, we'll stop it. And I like the fact that those two doctors, his oncologist and his cardiologist listened. Yes. They put the community and the empathy in it first, but it was a fact that they both said that the research doesn't tell us this.

Mm-hmm. Right. So it was a little concerning that you're going into this blind. So when I hear people say, DEI, doesn't matter. It's like it does because you as a person, you can be an older white person, but you may have a comorbidity. Right. And you weren't included in the trial. 

Melody Keel: Yes. 

Denise Bronner: Yet doctors feel it's okay to prescribe you that medication once.

So, and they're not even required for all the therapies that are on the market to do post-marketing. You know, research. Yeah, exactly. So it's like. We're not 

Melody Keel: keeping up with them. No. And you know what? Just really, it, it just hit me. Um, you know, so often, and this is across the board, it's not just in within one demographic where a clinical trial may be offered and people say, Nope, I don't wanna participate in that clinical trial.

I don't wanna be a research, a test rat. You know, all the, all the them said come up. But what, what you saying that just made me realize that. Oftentimes we are still research participants and we don't even realize it because even though it's been approved, if we weren't part of that trial or someone like us with our comorbidities and all the things that make us, us.

Then we're taking that and we are truly, but the bad thing about that is what happens to us may never be reported and the benefit for someone else to not have to go through what we did because that drug didn't work for us. Or it did have adverse events and down the, you know, the road. Yes. Um, we lost the benefit of that information.

Early, also our research participants, one way or the other, whether you consented to it or you're taking the drug after it's approved. Yeah. Education, right? 

Denise Bronner: Yeah. People don't understand that this is why you see recalls happening where they're like, we're having adverse events. Because now with in the population, yes.

And you're starting to see, oh. 

Melody Keel: What's happening in the world with everyone taking it now? 

Denise Bronner: Yes, exactly. So now you're starting to see the, the effects. And when they pull medications that work for some, but for others it's causing an adverse event. Now what are those people going to do? Now you have a population that has something work, it's removed.

While others could have had this prevented and not have to go through these adverse events, but some of these adverse events can really be quite life altering and now you're stuck. With these issues because it did damage to another organ. Yes. Right. So it's, it's, it's scary when you think about it. 

Melody Keel: It really is.

And, and can spiral you into. Uh, a lot of things and, and one, I mean, it could spiral you down to death, honestly. Like we have to, you have to think of that when you think of how I can start a domino effect. Um, I've had that experience in my family and, and it did lead to death and so I think it's education and helping everyone to understand it's not a race thing, it just isn't.

It. Yeah. Yeah. Alright, so let's talk about the unseen, um, cost of designing. Like we just talked about what happens from a human perspective, right? But what are the unseen costs? I'm very, I love that you work with, um, investment folks that are investing. Um, you give them knowledge behind about. The unseen cost, not knowing what you are doing, essentially investing blindly and not fully understanding how this works and that, I see that all the time from CEOs leading companies.

They've never been on the bench, they've never been a clinical trial patient. They've never sat down with ClinOps teams and understood what they do fully. Um, and so let's, let's break down the hidden cost, right, of not properly designing trials that are inclusive. Yeah, yeah. Oh yeah. 

Denise Bronner: The hidden cost is really just the fact that, I mean, when you think about the stat that they always put out there about, like, I think they say like 80% of trials never get, you know, never get completed.

Right. They fail. Mm-hmm. And when you look at the reasoning for it, a lot of times it's due to recruitment. And you think about how expensive it is to run a trial because there's so many moving parts. So it's not just finding a site, it's getting them the equipment, the kits that they need, the materials that they need, the site management that has to happen, the data integration and collection.

It's all these pieces that have to fit together. Yes. 

Melody Keel: All the vendor companies that are behind and vendors to make this thing for the sites. Yeah. 

Denise Bronner: And when you think about vendors in general. What I've realized with working with a lot of vendors and startups is that. They're trying to find the right time to make entry into pharma's sphere of influence to be able to get onto a trial.

But if you're unknown and you're not an approved vendor, you don't really get pulled in, even though you may be feeling an essential gap. And I've noticed way too many times pharma going with well established vendors who are approved getting the same results and complaining about the lack of. ROI and the cost 

Melody Keel: like, and the quality, someone else, right?

But to vet and qualify a new vendor, it's they, it's like we just don't wanna deal with that. So we're just gonna stick to who we have. 

Denise Bronner: And that's what they do. And I, and I understand it because I had to go through it a few times with new vendors, we have to go through and do all their data checks and look at their SOPs.

It takes a lot of work. But it's like if you do these once a year, once every two year open lot, where you say, any new vendor who's never worked with us can come in, do this round of going through getting checks and balances, getting everything figured out. Now they're in your system. So now procurement can say, we can do a, a better RFP.

Where now we have more proposals coming in. Yes. It's more more companies you have to review, but it's giving better competition. Yeah. For these types of trials. But the problem is, and I hear from a lot of vendors, is we're getting pulled in to rescue, and I'm like, yeah, the house was already on fire. You got pharma coming to you saying, oh my, I can help us fix this.

And you're like, I only have three months left. What are you expecting to do? 

Melody Keel: And these vendors, their model isn't fit for that. Their model is to partner with you from the beginning and put the proper infrastructure in place and have successful outcomes from that point. Not three months left in the trial.

Oh my God. It's not fair, fair to that vendor. 

Denise Bronner: And you know, even if you bring them in at the start of the trial, it's still too late because they're now forced to work with the boundaries that you have set and you a highly 

Melody Keel: expertise, 

Denise Bronner: yeah. Early on, yeah. Hired you, not have a highly restrictive protocol that.

It's going to have screen failure rates north of 50% for certain groups, and you're asking them to do the impossible when you haven't even chosen sites that are in the communities that would allow you to draw from a larger pool. So if you're bringing them in early as strategic thought partners. Yeah. To say, here's how we're thinking about this protocol.

What are you hearing from your community? Could we use some people from your community for patient voice to review this? Yes. If you have HTPs, can we use them the real world HTPs, not just KOLs, to say, what are we seeing? Does this make sense? Yes. How much of a burden this going to be? If you did that, you would see more dividends paid down the road.

And I've been on trials where we've done that early. Where they really did a great job with pulling together a strong advisory board to review this, to invest in vendors and to invest in materials that were the best for recruitment. Allowing for not only hitting your goals, but you were coming in early.

But the visible study that j and j did, which is a hundred percent skin of color in psoriasis, everyone in the industry was like, that is crazy. Overly ambitious. You typically don't see that 90% of psoriasis trials, like 90% of the participants are white. You're now trying to say you're trying to do a hundred percent non-white.

But they brought together a beautiful advisory board made up of key dermatologists who partnered with the Skin of Color Society to come in and review this protocol to provide insights. They chose the right sites, and when they rolled out, they were screening at such an accelerated rate that the kits that needed to be delivered, they were not able to keep up right away.

Couldn't even keep up. 

Melody Keel: Yeah. 

Denise Bronner: They came in three months ahead of schedule and for the first time ever, you had beautiful representation across all six Fitzpatrick skin tones for a trial. Never heard of that 

Melody Keel: up. It's just. It's just strategy and removing the barriers that it cannot be done. Yeah. Right. And so, oh, it can't be done.

We just have to keep business as usual and continue to do it the way we've always known. And that's what frustrates me about this industry that I love, is that. No, there is a better way. There's a new way. Embrace it and let's be successful and, and get an outcome that doesn't look like what we always get.

Um, it, yeah, it's just baffling and mind blowing to me. 22 years in, it's, it's still, yeah. It's under my skin and just bugs me like none other. Um, but I think the other thing that I wanna say that you hit on is the importance of community engagement. And, um, I, I saw a post on LinkedIn yesterday from someone that I admire and I've spent some time with her and she does the real deal grassroots community efforts.

And it's not fair when we just go in and use the community for our gain. Then we're gone. Yeah. What you really have to make the investment, and it's not just a monetary investment, it's time, it's commitment, it's showing that you are trustworthy as an industry and a company to go into the communities that we need the representation from and to really.

Partner and, and get the feedback and bring them in early, like you said, to be part of the protocol design and the positions, and to let them be investigators so that we have proper access to the populations and they can really make sure that the protocol in the trial is a benefit to their patients.

Right. And it's not just gain for our industry. And so I think that's such a key part, is the community engagement, and we miss that so many times. 

Denise Bronner: Yeah. I've had so many times where I was in conversations with colleagues within the organization and they were trying to understand why, like when we're talking about awareness, they're like, there is no direct ROI when it comes to recruitment.

And I said, how do you figure, like, well, when we're talking about raising awareness, we're doing all these events and things, but what are we actually gonna see any type of impact in our trial? And I'm like. You have to understand every time you go in cold into a community. You are starting from the bare minimum, right?

You're starting from nothing and then you're trying to warn them up too quickly. 

Melody Keel: Yes. 

Denise Bronner: And get them into your trial and you go, but you cannot do that if you have sustained engagement with communities. 

Melody Keel: Mm-hmm. 

Denise Bronner: Now they're listening to you because you have empowered them with information to help them on their healthcare journey.

So it's not just your trial, you're saying, have you, do you even know what the symptoms are for this condition? Mm-hmm. Because I bet you. Right. You are probably exhibiting some symptoms and you don't even know it. You know how has a conversation with your doctor. Yeah. Showing them how to do that, pointing them in the right direction, giving 'em the resources that they need before you sell is so important.

That's why a lot of these vendors who are coming into the space, you're going, you have to have awareness. Yes, yes. But how do you, how do you translate that? And you have to talk about, well, what are gonna be those KPIs, those metrics. That's the key piece that I think it's missing. And you're starting to see this change now.

Because when DEI took off in 2020, a lot of people who are in it, they're like, this was nothing new. But in 2020, everybody's swung. So all this money, all these projects, and you are like, well, what were the KPIs and metrics? Two to three years later, people start saying, DEI, fatigue. Now we're in 2025. And in at the end of 2024, you were seeing these massive pullbacks on, on budget.

You were seeing vendors being extremely hard pressed on metrics because they were getting it from higher ups. Yeah. And now you're going, well, how are you tying this back to business? And I have always said, if you're not showing how you're saving time, money, increasing their money, or a customer pool, you're not gonna show any type of impact, and you're not gonna pay attention.

And it's 

Melody Keel: not gonna go far at all. And it can ease. And that's how it's been so easy to just nix it. Yep. Yeah. That's why. Yep. Oh my goodness. I think we could spend, um, so much time, so much time, um, on this. So I, I think at the end of the day, um. It is a business advantage for inclusion. Yeah. But that, that's not the sole reason why we do this.

Um, we're not just chipping a compliance box and I think that's what's. So critical for everyone to keep in mind. Um, and sometimes I call it business selfishness when we're so self-centered on what we need. Um, but if we truly embody patient first, then the community engagement and becoming a trusted partner of the people that we want to bring into our trials shouldn't, it's not, it's not that heavy of a lift, right?

No. If, if we truly embody that and live that, and so I, I think I like that. I like that even though we're in the same industry, but we kind of have on different sides. Right? Different approaches. Yes. We, we arrive at that same kind of, this is the end goal. I love that. Every time this is where we end. Um, and it does come back to patience first.

Denise Bronner: It does. It does. It really does. I think we have to keep patients in the center, but you have to do it in an intentional way. And what I've realized, and I was just talking about this with, uh, another client, is you have to, when think about DEI, it's always been from a very altruistic point of view. It's the right thing to do.

You know, you have been underrepresented or you have been overlooked, underserved, and it's always coming from a very disadvantaged point of view. And I, so why don't we flip it on its head and say that there's actual value add? Yes. That if you are using and having a proper amount of representation, you have enriched the scientific knowledge and data that can inform your asset portfolio.

That can give you a competitive edge on marketing. Mm-hmm. If you think about the fact that you're. Pulling these people into your trials now, you now have the evidence to convince them when it becomes commercially available. 

Melody Keel: Yes, you 

Denise Bronner: have. There's a lot of business pieces. It could get you what your trials done faster.

You have a competitive advantage. You may find out that you have something that completely changes another, you know, uh, condi condition or disease. Now you have the ability to expand the label. 

Melody Keel: But 

Denise Bronner: this is where it's coming from in the data. So I think if people started putting it in that context and not just being underserved or overlooked, you start to tie it value to it.

And I said, you need to tell even your community members that you are influencing multi-billion dollar business decisions. Let them know the value that they bring so that they're more willing to lean in on it. 

Melody Keel: Yes. I think that is a absolutely excellent viewpoint. I like that. Taking away the disadvantage and really focusing in on the advantages.

Um, yeah, that's good stuff. So I'm gonna. Move towards wrapping this up, and I just have to ask you, um, because I'm, I'm, I live in the ClinOps world and I know that you work with leadership and c-suite executives and investors and, and all the things then because operations is the heart, right. Of clinical trials.

Yeah. And so if you could ha give a message to leadership, right? Mm-hmm. Um. What would you say in terms of building trials that respect the complexity? Even just this very brief conversation we've had, we've touched on so many different sides, uh, of clinical operations and trials. So what would you, what would that message be?

Denise Bronner: I think the biggest thing is open up your pocketbook, right? Because we have to, I mean, I've looked at when we would pull in certain vendors. And you're looking at what the costs or what their proposed budget would be compared to others, and I'm like, why are we not distributing the funds a little bit more?

Right. You're looking for this one type of vendor who can do everything from end to end, and that's just not possible. Why don't you break it up, but give a good amount of money to your study teams to do the work that they need to do effectively? Why don't we try to think about novel ways of pulling in different types of sites and they always contracting it's length of time.

Takes too long. It's like, figure out a way to fix that. Right, because you are literally going to the same well every time, expecting more, more to come out and you're like, but it's not being replenished. So my thing is, it's like with leadership, listen to your teams. Right. Stop and listen to the teams to actually doing the work and telling you, this is what we need.

Yes. Instead of trying to be so lean. Because you're trying to increase your profits. It's like at the end of the day, yeah, you may increase it for a little bit, but imagine the amount of returns that you could have if you did more. And I remember talking to leadership one time where I showed them.

Without you guys doing anything, non-whites make up 15 to 17% of your market share right now. Right. Of your customer base. And that's, you guys not doing anything. If you increase that just by a mere two to 3% because you've shown them what the trial, this is what that could lead to in profits. It was insane.

It's like so tying it back in, that investment that you're putting in now is gonna give you greater DI dividends down the road. So. Invest, listen, you know, and, and really fully support the teams that are working on this stuff. 

Melody Keel: Yeah. Lean in and trust your experts. You have to, your experts are sitting right here next to you, and they give you the resources to make it happen.

Exactly. Exactly. Well, this has been an amazing conversation. I think we could do this probably for another four hours and still be going. Exactly. Appreciate you stopping in and, and having this discussion. I think it's really important and, um, I'm hopeful that. People will really take it to heart and, and put themselves in the shoes.

Right. And, and what is their role and do you have the ability to increase the resources? Do you have the ability to lead teams better and allow them to be the experts and to share what they know to make things better and get better outcomes quickly? Yeah. Not to keep doing the same things over and over again.

For sure. At the end of the day, patients first, and it's personal because we both very personal. We all do. We all have family members are individually impacted, right? Correct. We're just getting it right. Yeah. Yeah. Oh, yes. 

Thanks Denise. I appreciate you. No, thanks for having me. 

Yeah.

People on this episode