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ADA award winner focuses on the future of study design
John B. Buse, MD, PhD, has been fortunate enough to have numerous mentors in his life. From his parents to the late George Eisenbarth, MD, PhD, Buse has had the chance to learn from many experts in the field of diabetes. Now a veteran of the field himself with more than 35 years of experience, Buse is able to share his own advice. One piece he emphasizes is having a career that combines research and time in the clinic. The Verne S. Caviness Distinguished Professor in the school of medicine at the University of North Carolina was awarded the American Diabetes Association’s Outstanding Achievement in Clinical Diabetes Research Award this year.
Buse, who also serves as a professor in the division of endocrinology at the department of medicine of the North Carolina School of Medicine, spoke with Endocrine Today about the evolution of clinical trials and study design, the small steps that change the history of medicine, and how his relationship with his parents helped shape his career.
What was the defining moment that led you to your field?
Buse: Both of my parents were diabetes investigators and clinicians. They met during an endocrine fellowship. I spent the next 20-something years trying to avoid endocrinology and failed. I didn’t want them to figure out how inept I really was, but when I was an MD/PhD student, I ran into a guy named George Eisenbarth, who became my mentor. He happened to work in the immunology of type 1 diabetes, and that’s how I ended up back in the diabetes space. I fell in love with the wonder of insulin. We were breeding and doing genetics in type 1 diabetes animal models, and it was just a miracle drug how it rescued these rats from near-death in just a matter of hours.
Probably the most-defining moment has been moving to the University of North Carolina. The infrastructure here enabled me to develop a clinical trials team. We’ve been able to make contributions in a number of different areas. It’s a relatively unique facility with six examine rooms and a bunch of space for coordinators and storing drugs and samples. It’s allowed us to be very efficient. That’s really been the key to my success.
What area of research most interests you right now and why?
Buse: In general, my work is focused on developing better drugs and treatments and understanding how to use older treatments to greater effect. What I’m most interested in is issues around study design: how to do research better, faster, cheaper. There’s an area where I’ve only been working for about 8 or 9 years called pharmacoepidemiology using large data sets to try to resolve questions that aren’t really possible to do in clinical trials. One of the novel areas is linking the electronic health records date with claims data. That’s something we’re exploring now that is going to be extremely powerful.
In clinical trials, the other area that I spend most of my time in, I really like the idea of working toward more pragmatic trials, less structure than the average FDA-regulated trial where you can start to understand how a drug would really work or how a treatment would really work in clinical practice.
What do you think will have the greatest influence on your field in the next 10 years?
Buse: In the clinical trials space, I think the biggest influence will be the stance that the FDA and other regulators take. A lot of the things we do we do because of these regulatory guidances, and some of them suggest greater flexibility with regard to the kinds of trial designs and endpoints and how they’re collected. It’s unclear how much flexibility there really is. I do think we could be more efficient and effective in our national efforts at discovering new treatments with some regulatory reform in the space. I don’t know if it will ever come to pass, but certainly it would have a huge impact.
What advice would you offer a student in medical school today?
Buse: When I talk to medical students or residents or fellows or even junior faculty, they get a lot of advice, so the more personal insights that I have might be related to a career that combines clinical work with research. Fundamentally, I suggest to them that it provides for an incredibly robust and rewarding career where you are able to enjoy the patient interaction, helping people, the reason why most people go to medical school. At the same time, collect data about new insights about how to better deliver care in the future. Combining both makes you better at each. For me, it provides for a career that even after 35 or 40 years, I’m pretty much excited about going to work every day. Sometimes I’m overly tired and would love to sleep in, but in general, there’s not a rut in what I’m doing. Every day is different, and over the years we’ve been able to focus on many different areas. My advice would be to think about careers that combine clinical care and research.
Have you ever been fortunate enough to witness or to have been part of medical history in the making?
Buse: I wouldn’t say it happens every day, but it happens pretty often. There’s an iconic image in the type 1 diabetes space. Sometimes it’s called the ski slope, but it’s a plot of beta-cell mass vs. time. Basically, the point is that people are born with a normal beta-cell mass, and there is some kind of triggering event and then a process of immunologic destruction and decline in beta-cell mass to the point where type 1 diabetes evolves. The original drawing of that figure, I’m essentially certain, was developed by George Eisenbarth. I remember seeing various interactions of it over a period of weeks as I was working on a particular manuscript. Now every time I see that drawing, I remember those days when he and that group that I was working with were sorting out their view of that process.
Later in my fellowship, I worked on the genetics of type 2 diabetes and, in particular, glucose transporter gene. In the basic science space, with regularity you find new things that, at least at that moment, are very important in moving a field forward. There are these jumps in science that sometimes result in fundamental insight and sometimes Nobel Prizes, but for the most part, it’s a slow walk to the future. Every step, in a way, is medical history in the making.
Whom do you most admire and what would you ask that person if you had 5 minutes with him/her?
Buse: There are so many people to think about. I’m a huge admirer of Barack Obama. I think it’s just stunning. He is clearly the historic figure of our time, but I have to say if I could have 5 minutes with anyone dead or alive, I’d really want a chance to talk to my father who died almost 20 years ago. As I get older and start thinking about retirement, I do wish parents lasted long enough to mentor us through that part of our lives as well. I’d catch him up on what I’ve been doing and ask him for some advice around end of career stuff. – by Phil Neuffer