You're listening to Beyond the Endpoint, a podcast from the Duke Clinical Research Institute. In this series, we're demystifying clinical research and answering your pressing questions about health and health care. You can find our full episodes at dcri.org/bte.
In two seasons of this podcast, we've talked about where clinical research is going and its future. Today, we're kicking off season 3 of Beyond the Endpoint by talking to the people who've been essential to its history and their take on the future. I'm Dr. Manesh Patel. I'm the chief of cardiology at Duke University and a faculty member at the Duke Clinical Research Institute.
And I'm Dr. Emily O'Brien. I'm an epidemiologist and associate professor of population health sciences at Duke University.
This year, the DCRI turns 30. To mark that milestone, we're doing something a little bit different. This is the first in a two-part series where we will hear from the people who have led this institution across its entire history. Think of it as a sandwich today. You get the bread: Dr. Robert Califf, DCRI's founder, and Dr. Adrian Hernandez, the current executive director. The next episode, we hand things over to the directors in between, Dr. Bob Harrington, Dr. Eric Peterson, and Dr. Leslie Curtis, who we should note did quite a bit of heavy lifting.
Both of our guests today are Beyond the Endpoint veterans. Listeners will remember that Rob joined us in season 1 to discuss the intersection of science, policy, and public health. And then Adrian Hernandez closed out that same season with a conversation about clinical research through a sports lens. Rob and Adrian, welcome back.
Thirty years ago, Duke University had a rich but narrowly focused asset, the Duke Databank for cardiovascular disease, a meticulous registry of patient outcomes that had become one of the most valuable tools in cardiology research. The question was whether something larger could be built around it. Could an academic home for clinical research operate at the scale, rigor, and independence that the field demanded but rarely found? This idea became the Duke Clinical Research Institute. What started as an answer to a specific problem in cardiovascular medicine has over three decades grown into one of the world's leading academic research organizations, shaping how clinical trials are designed, conducted, and translated into clinical care across multiple areas of medicine.
Thirty years is really worth pausing to reflect on. Our 20s were fun, but we're leaving those behind and looking ahead toward the future. So we want to kick this conversation off with a couple of big questions for you both. And I'm going to go a little off script here, but since we started with the bread analogy, Adrian, if Rob were a type of bread, what type of bread would he be? And then we can reverse. Okay, Rob, what do you think? What's Adrian?
I got to say, in my research for this episode, which was extremely in-depth and scientific, I did ask AI if DCRI executive directors were bread types, what would they be? And so, not only does it know both of you, it actually has opinions about what type of bread you are. Rob, you're sourdough. Deeply fermented ideas, foundational, intellectually rigorous, somehow connected to every important conversation. People either leave inspired or with three new papers to read. Adrian, you're ciabatta. Big open structure with room for lots of ideas and collaborators. Comfortable with complexity, always seems to be building the next ambitious thing, and somehow makes it look easier than it is.
I can't wait for this analogy to continue going forward, because I'm really interested in what's in between the slices of the bread for your next episode. Who's the peanut butter? Jam? You know, who's the salami?
Yeah, yeah. There might be some Nutella in there also.
That's right. That's right. All right. So, back to our conversations about DCRI, just sort of starting off at a high level, when you think about the impact of the DCRI so far and how clinical research has changed as a result of DCRI's existence, what kinds of things come to mind?
For me, it's always looking for the places where the DCRI is helping people think differently about what they're doing. I mean, just looking at the technology, the way it's evolved, it's quite astounding. When we started, we literally had one of the few academic medical centers that had computing as a key part of the infrastructure. It was a new thing. And of course, now we're in this entirely different era where you're looking at people on slices of bread and somehow they're connected in a way that none of us can explain. But you know, I would say maybe this is consistent with what you said about the slices of bread, but I would say that the world of clinical research has expanded dramatically, and yet we're only a fraction of the way towards where we should be given what we now know.
Adrian, as you think about 30 years of DCRI, what do you think are the ways that it's responded to some of those challenges, and what do you see as some of those challenges coming to continue to stay relevant to the conversation of trying to think about things differently and evolve to answer clinically meaningful questions?
One of the key spirits that DCRI has as part of its foundation is answering relevant clinical questions that will improve people's health. And so there has been this idea from the very beginning that there's a patient on the other side of this question. So what can we do a little bit better for them? How can we get better evidence for them faster? How can we make sure that it integrates in terms of what we see as evolving clinical care? And you know, we talk about this at DCRI. People talk about organizations and who their stakeholders or shareholders are. For us, it's really our patients. And then it's patients not just around the Duke area but around the world. And so I think that's one of the things that's been most impressive over the years, that patient-centeredness.
One of the other common themes that's come up as we've talked about 30 years and done some reflection on the leadership team is that, you know, it's really about the people. And DCRI is quite unique, and the people are really the most valuable asset, the most unique piece of it. And you all have a really long history and a strong partnership and great friendship. Tell us a little bit about your earliest memories of one another and how that partnership got started.
My early memories of Adrian are being on conference calls where his voice was so soft I couldn't hear what he was saying. I used to yell at him, and then my wife Lydia would yell at me for yelling at Adrian. That was sort of the dynamic that went on. But I think, you know, when you describe Adrian as a slice of bread, it's sort of an acceptance of diversity in the world and an ability to deal with it in a way that very few other people can do. That is, accomplishing things while also not excluding people from participating in the effort. It's sort of that quiet, unspoken part of Adrian that I think always made the difference.
This is the fun part of the conversation, getting to hear about a side of someone that you feel like you've never seen before. Adrian quiet on conference calls, that's a new one for me. Adrian, what did you think when you first met Rob?
Yeah, well, there are obviously a lot of different memories early on in terms of, you know, actually why I came to Duke. So, as I was doing my interviews for fellowship, I was describing what I wanted to do, and I remember this directly at UCSF where I was a resident, everyone except for the chief of cardiology said, 'You really need to go check out this place called DCRI. There's this guy, Rob Califf, who just started up a few years ago. It sounds like what you want to do in terms of outcomes research' — is what they called it then — 'and clinical trials is something he's trying to put together. You really should go do that.' And they also said, 'Don't tell the chief of cardiology that I said that.' And so when I actually came out here for my interview, they had me scheduled with Rob.
And I'm not sure exactly what was going on that day. He didn't have any paperwork or anything for me there. I just showed up in his office. He said, 'Okay, well, can you tell me why you're here? Like, I don't have anything about you.' And so I had to kind of describe my story, and he said, 'Okay.' And then he starts describing the vision for DCRI, you know, really trying to get clinical research expanded rapidly in this new way that hadn't been done before. And the other thing that he noted was that it was bringing different disciplines together: the evolving world of computers back then in the early 2000s, how that would be important, and working with bright people and understanding how to do something better in terms of methods and statistical approaches. And so that was, you know, kind of the sell, and so I was all in.
And then when I came in later, and this was actually kind of in a parallel time with Manesh, we were just starting some parallel trials. Manesh was the clinical lead for this trial called ROCKET, which is the 'have all' trial, and then I was the clinical lead for this other trial called ASCEND-HF, the 'have not' trial. Rob was a chair for both trials, and I remember meeting Rob at the very beginning of this, that we were about to get this awarded, and Rob pointed next to the chair I was sitting in and he said, 'See that box of Kleenex?' I was like, 'Yes.' He was like, 'Well, I'm going to push you so hard you may have to use that.' And so from that day forward, I was going to make sure that whatever we did, we were going to be really driven and beat ROCKET, and even though they had the most resources, that we were going to crush it in terms of what we needed to do for recruitment and delivering great results. So that was one of the earliest memories, and I didn't actually have to use the box of Kleenex. I came close a few times, but I didn't have to use it.
I'm excited that you didn't have to use it. Surprised that you didn't, but excited that you didn't. Your story's reminiscent to me in the sense that I was around the same time getting to interact with Rob from a different lens, as a resident at Duke thinking about fellowship. One of the things that Rob has done, which I think is the outpouring of the DCRI, is building a culture of curiosity and trying to get the answer. You know, we could talk about methods and we could talk about technology. We can talk about all the ways you want to do it, but that curiosity driven by real clinical questions and trying to get the answer. And I remember tying into the ROCKET story. I was an interventionalist just starting in the fellowship over there at the same time as Adrian, but I wasn't interested in atrial fibrillation as much at that time, and I sort of brought it up, and, 'Well, you're going to get to do a trial with Ken Mahaffey and Rob Califf. If you want to learn how to do trials, you better spend some time with people to understand that.' So there's a balance between giving people enough rope and not too much rope. I would just say Rob's been quite masterful in letting you get just to the edge of jumping off the cliff and then pulling you back as a person who's learning how to do these things, and so that is one of the things I still struggle to do. It's hard to let go. It's hard to have people that you're mentoring or working with. And one of the things that I think really engaged people at the Duke Clinical Research Institute — or hopefully still does — is that you get to, at an early age, be in the co-pilot seat with somebody, making sure that they're letting you fly the plane, but they're going to be there with you.
One thing I often describe, especially as we're recruiting faculty or research fellows, is that one of the things that came out in the very early days of DCRI with Rob is what I would call irrational decision-making — putting people forward first and trying to get them quickly to have that depth of experience. But somehow being able to understand behind the scenes where things are going, so that at the right time, like, you get this call from Rob about just checking in, what's going on. And you think it's just kind of a blind call, but there's something behind it that he's picked up in various ways, and so checking in about where things are going for a trial or program or initiative, and asking the right questions that either make sure that you get back on track or actually help you identify, like, 'Oh my God, there's a problem here, Houston, and we need to address it.' Behind the scenes with Rob is that putting people forward fast is a key thing that we've tried to take on going forward.
When you come on and we've had conversations with you, Adrian, you've had this sort of sports theme that you've come back to. And as you think about your journey from early-career trainee now to executive director, what's that been like to go from rookie to coach — or manager, owner, leader — for the organization?
Well, it's been a lot of fun, and you know, Rob touched on this earlier, but one of the greatest joys and experiences is when you see people, whether it's here at Duke and at other institutes or elsewhere, leading programs, leading teams, leading institutions. And then I think one of the things that we learned very early from Rob is that it's important to make sure that so-called rookies get the at-bats. They get on the mound in the games. Otherwise, how will they build their confidence and be able to be a leader? And so very early on, trying to get people to jump in is really important. And then being the coach and saying, after the game, so to speak, 'That wasn't the best game. Here's what you can do better,' or 'When this play comes up, this is a better strategy for that decision.' And so making sure that people have that experience early on, but also being a coach to help people think about it better the next time, is really important. And then I think the other thing that we've learned over the years is that it's really important to get people lots of different exposures to different opportunities. Whether that's having exposure to what happens in the regulatory environment, what are the hard decisions that folks at, say, the FDA have to make, what are the hard decisions that, say, payers have to make. Having people network and understand those challenges so then we can be better in terms of what's the evidence that we need to help create that makes the decisions a bit easier is important.
