Transcript
Speaker: Welcome to the Trials and Tribulations podcast from the UNC School of Medicine's Clinical Research Alliance. This is a podcast about the people and the systems behind clinical trials.
Speaker: How the research actually moves, what slows it down, and what high-performing teams do differently. I'm Michael Sledge, co-host and the Vice President and Chief Business Officer of the CRA.
Speaker: And I'm Dr. John Buse. I'm the therapeutic area leader for diabetes and metabolism at the CRA. So Michael, I've known you for about 10 years and I actually don't know the story of how you ended up in clinical research. Obviously you didn't go to business school to do that.
Speaker: No, that's true, John. I'm an accounting and finance person by my formal technical training. I had the good fortune years ago to work for a couple of clinical research organizations, what used to be called Quintrals, and then Quintiles, now a part of IQVIA. And then I had the really good fortune in 2006 to get recruited to Duke University to be the chief financial officer for the Duke Clinical Research Institute.
Speaker: And after about 11 years there, I came to UNC in different roles, but eventually made my way back around the clinical research. I think that's my home. How about you? What do we need to know about you, John Guse?
Speaker: Yeah, you know, it's interesting. I was born the son of two diabetes specialists. They met doing their fellowship, and I guess I was destined to do that, though I struggled really hard not to.
Speaker: But my first introduction to clinical trials was actually as a volunteer, first in high school because I was aware of them through my parents, and I actually found it fascinating to to be involved in something as a normal volunteer. I didn't have a a problem, ah but I participated in studies to determine how much loud sound you could be exposed to for 24 hours. And one of the first studies of ah imaging ah ah technologies for cardiovascular disease.
Speaker: So it was really interesting to be involved. And eventually, I got the chance to do clinical trials after a career as a basic scientist and physician. Yeah, and then just tell us a minute about your NCTracks career, because that's pretty remarkable.
Speaker: Yeah, so I spent about, um i guess, 25 years leading multicenter trials, ah ah sometimes globally, usually in the United States, sometimes just regionally or or locally. And then there was a RFA from the National Center for Advancing Translational Science at the NIH for the so-called CTSA awards. And ah UNC put in for one, i was asked to help with the clinical research part of it by the original PI in over 20 years, had a variety of roles, including being PI of the UNC CTSA and the
Speaker: co-chair along with NCATS director of the steering committee for the CTSA consortium. And and that that program is really focused on making clinical trials easier, easier better, cheaper, faster across the nation.
Speaker: So fair to say you've got some legitimate chops to be on this podcast then. Yeah, but you do too. Good. I'm looking forward to this. Maybe one more comment. ah ah It seems like that that clinical trial way back when of the how loud can you stand up for 24 hours probably was a good good thing to do before you went to undergrad, right?
Speaker: Right. ah You know, undergrad, but, you know, it's pretty noisy in some of these conference rooms when we're struggling with design and money issues in clinical trials as well.
Speaker: Okay. Trials and Tribulations is going to be built around four themes. Operational, practical, credible, and human. Every episode is going to come back to one of those themes.
Speaker: We're going to bring on investigators, coordinators, regulators, sponsors, and partners. People who actually do this work. Some you will recognize, many you will not.
Speaker: And that is the point. Just a note, the show is educational and informational. It does not provide medical advice. Between Michael and I, we've spent decades inside academic research organizations, federal trials, and the day-to-day operations that pull multi-site studies together.
Speaker: We're going to share what we've learned and what we're still trying to figure out. Here's the premise. Clinical trials are essential, and they are deeply underappreciated.
Speaker: And most people, even inside medicine, think of a trial as a single investigator running an experiment. But a modern trial is really dozens, hundreds, or thousands of people across between handfuls and hundreds of sites, all of them solving and contributing in different ways ah to solve the puzzle, to get an answer.
Speaker: And those answers can change the world. The work is much bigger than any one investigator or any one coordinator or any one individual.
Speaker: And when a trial is slow, it's over budget, or it begins to fail, the temptation can be to blame the science. But most of the time, it's not really an issue with the science, but the system behind it. Things like contracting, regulatory, site activation, data flow, and communications.
Speaker: And the good news, which is really the reason why we're doing this show, is that the systemic problems, the system problems can be fixed more easily than the issues with the science.
Speaker: You can make trials more efficient, cheaper, and faster without giving up anything on the safety and rigor of the experiment. So, John, tell us who the audience is for this podcast.
Speaker: Well, I think off the bat, the sort of natural audience will be people that are in the clinical trial business, either as investigators or coordinators or regulators, ah people from the CTSA world. But in fact, ah the people that I hope listen are the people that are not in clinical trials. Perhaps people that are just like I was when high school and in college were perhaps interested in being a volunteer, or ah people that are kind of looking for a career, they like science, they like the idea of helping people and working with people, they might choose to to pursue a career in clinical research. That's probably the ah people that I most want to reach.
Speaker: But also clinicians who are involved in the day-to-day care of people ah in a you know, who are well and people who have illnesses and have never gotten into clinical trials because they were kind of afraid of what was needed. I'm here to tell you that if I can do clinical trials, you can do clinical trials. It's more about interest and a little bit of training, which you can do over a few hours that will get you set up for a robust career in clinical trials.
Speaker: that's I think that's very well said. That's a great audience. If you are a researcher or you work in a clinical trial space, you can expect a deep dive into how trials work in the real world, what causes us the delays everyone complains about, and what the teams that do not have those delays are doing differently.
Speaker: And we're going to be candid. We're not going to pretend that everything in clinical research is solved or that everything always goes perfectly. Episodes are going to run about 25 to 30 minutes. One central topic plus two or three recurring segments.
Speaker: Let's give you a quick sample of these right now.
Speaker: So, for example, burn rate is a segment about one specific cost of delay example, because in this world, time is money. Here's one for today.
Speaker: A 90-day delay in site activation on a mid-size multi-site trial can burn six figures in fixed costs before a single patient is enrolled.
Speaker: Coordinator salaries, regulatory upkeep, project management, The clock starts the day the award lands, and the fix is almost never one thing.
Speaker: It is usually three or four things in parallel. Pre-negotiated master agreements, single IRB workflows that are actually used, and a project lead who will pick up the phone and call someone.
Speaker: Okay, myth fact. A trial only needs one good principal investigator to succeed. John? but Clearly a myth. Now, we were talking about multicenter trials in particular. We were talking about it as a team sport, you know, as is true in all team sports.
Speaker: The weak link is the weak link. A trial can fall to its knees based on the performance of anyone. A great PI is a great thing to have, but a great study coordinator, likewise, is a great thing to have.
Speaker: ah A PI cannot solve all the problems in a clinical trial. Okay, myth or fact. Faster trials means cutting corners on safety.
Speaker: Myth, and really an important one to clarify. Most of the speed that we've gained over the last decade really comes from removing redundant paperwork and not from cutting oversight or getting the data that we need to make the case for a new treatment for a disease. Safety stayed where it was,
Speaker: Sometimes it even improved with these more efficient study designs.
Speaker: Okay, for our game time segment, I'll tie a moment in athletics to clinical research. Here's one. When we talk about a principal investigator, most people picture a scientist alone in a lab.
Speaker: Principal investigator on a multi-site trial is really like a top-tier coach. They don't run every play themselves, but they pick the team, they read the field, and they adjust in real time across dozens of sites.
Speaker: And like in baseball, you can have all the talent in the world, but if the team is in a line, you don't win games. You don't finish trials either. So, you know, Michael, I think this coach analogy is great for the PI of a trial, the tippy-top PI of the trial that's not actually at the bedside, but, you know, helping to make sure all the sites are working together. But we need to remember that most of the PIs in the world are site PIs. They're You know, basically the the coach that's almost in the huddle of the team aye getting each of the ah of the patients that are enrolled in the trial and randomized in the trial, making sure that everything is going well for each individual participant in the trial. And making sure that data is collected in the appropriate way ah so that you can have an answer to the study question at the end.
Speaker: I think that's really good clarification, John, to point out those two differences. Okay, before we let you go, here's a sneak peek at the next three episodes. Okay, episode one, the sausage, the science, and the impact.
Speaker: We're going to be joined by Dr. Nick Shaheen, who was formerly the chief of the gastroenterology and hepatology department at the UNC School of Medicine. He's probably best known for his groundbreaking research on Barrett's esophagus.
Speaker: Episode two, the multimillion-dollar team sport from individual science to the science of science, why we need UNC's TRAX Institute and the broader CTSA infrastructure to make trials better, cheaper, and faster.
Speaker: For this episode, we'll be joined also by Dr. Shaheen, who's also the director of the NC TRAX Institute. In episode three, it's probably going to be one of my favorites, decoding the acronym SALAD.
Speaker: So and it's exhausting to say all those, and most of our listeners might not know what those mean.
Speaker: Why are these so-called boring terms often the difference between a trial starting or stalling? Join us on episode three and you'll find out why.
Speaker: Thank you for listening. If you're a researcher, coordinator, or sponsor, partner, or community member who wants to learn more about cutting-edge research and clinical trials, this is the podcast for you.
Speaker: Thanks for joining us today. John, great to get this thing started. See next time.
