Urologic Oncology Clinical Trials: Size, Scope, and Impact - Kristian Stensland
July 11, 2024
Ruchika Talwar interviews Kristian Stensland about his publication in Urology Practice on the size and scope of urologic oncology clinical trials. Dr. Stensland discusses their analysis of trials registered on clinicaltrials.gov since 2007, revealing that over 100 patients enroll daily in urologic oncology trials, totaling about 28,000 participants annually. Despite this significant number, enrollment is decreasing over time. Dr. Stensland emphasizes the importance of improving clinical trial design, implementation, and training for all urologists. He highlights the need for better evidence about clinical trials themselves and suggests focusing on bringing trials to patients in community settings. The discussion underscores the significance of offering trial participation to patients, as most are willing to engage when given the opportunity. Dr. Stensland concludes by encouraging all urologists to learn about and engage with clinical trials to advance the field.
Biographies:
Kristian Stensland, MD, MPH, MS, Urologic Oncologist, Health Services Researcher, University of Michigan, Veteran Affairs’ Ann Arbor Healthcare System, Ann Arbor, MI
Ruchika Talwar, MD, Assistant Professor of Urology, Urologic Oncologist, and Associate Medical Director in Population Health, Vanderbilt University Medical Center, Nashville, TN
Biographies:
Kristian Stensland, MD, MPH, MS, Urologic Oncologist, Health Services Researcher, University of Michigan, Veteran Affairs’ Ann Arbor Healthcare System, Ann Arbor, MI
Ruchika Talwar, MD, Assistant Professor of Urology, Urologic Oncologist, and Associate Medical Director in Population Health, Vanderbilt University Medical Center, Nashville, TN
Read the Full Video Transcript
Ruchika Talwar: Hi, everyone. Welcome back to UroToday's Health Policy Center of Excellence. As always, my name's Ruchika Talwar, and I'm a urologic oncologist at Vanderbilt in Nashville, Tennessee. Today, I'm excited to be joined by Dr. Kristian Stensland, who's an assistant professor of urology at Michigan Medicine. He'll be chatting with us today about some recent work that he published in urology practice about the size and scope of urologic oncology clinical trials. Dr. Stensland, thanks for joining us.
Kristian Stensland: Yeah, thanks so much for the invitation. Happy to be here and chat about our work. So yeah, thanks so much for the opportunity to present our work. I'm going to give us a brief intro and overview of where our work came from and what we were looking at. Again, as you mentioned, we've looked at the size and scope of the Urologic Oncology Clinical Trials Enterprise, and I always kick [inaudible 00:00:50] off by saying I have no financial disclosures, but do have some funding from the NIH for this work. Anytime I talk about clinical trials, I always want to highlight clinical trialists as well as participants in clinical trials because clinical trials are a huge amount of work. So I always want to show appreciation and respect to everyone who's involved in trials, from level of funders and regulatory agencies, all the way down to our patients and clinical trial participants. Anytime we start talking about clinical trial failure, I think the importance here is that we want to focus on future improvement, not to indict those who are involved in trials.
With that kind of a preamble, I did want to talk about estimating the size and scope of Urologic Oncology Clinical Trials Enterprise, which was recently published in Urology Practice. Again, I want to recognize my co-authors for their help in this work. Really, the preamble to this or the principal question behind this paper was why should any and all urologists care about clinical trials? There's theoretical benefits of clinical trials being important to advance science and trials really underpin a lot of our guidelines and help us direct our clinical care. But a question that comes up frequently is, are there really that many urology patients who are involved in trials and why should this apply to people who maybe aren't running their own trials or designing their own trials? So we sought to answer this question of how many urologic oncology patients there are who are actually involved in trials so that we can contextualize that compared to other things that we're examining. So to answer this question, we accessed all phase two to three interventional urologic oncology trials that were registered on clinicaltrials.gov since 2007.
This was when there was an FDA amendment act as well as some other legislation that required clinical trials to be registered, which is why this specific date pops up in the literature quite a bit. Then we calculated the cumulative actual enrollment for either completed or terminated trials and the anticipated enrollment for trials that are still ongoing, so I haven't read out the results yet. What we found was we identified almost 11,000 total trials, of which almost 5,000 were completed, about 1,500 were terminated, meaning they were closed before they reached an anticipated endpoint, and there are close to 4,500 that are ongoing. But to those that were completed or terminated, meaning no longer enrolling patients, there are about 473,000 urologic oncology patients enrolled. Then for the trials that are currently ongoing, there's almost 600,000 participants that are needed to complete all of those spots. So putting those results in context, that means that there are over 100 patients, 107 participants on average, that are enrolled every day into a urologic oncology trial.
This means that over the course of the year, there are about 28,000 urologic oncology patients enrolled into a trial, which means there are more urologic oncology trial participants per year than there are new cases of testicular, penile, or ureteral cancer combined. There are unfortunately fewer participants who are enrolling per year over time. So when we bunched this out by year, within the last five years, there are fewer patients than there were the years, five years before that and the five years before that. So unfortunately, enrollment does seem to be decreasing, at least on a per trial basis.
So our conclusions from this are that there are many urologic oncology patients that are impacted by trials, not just from the results of them, but also from the conduct and implementation of the trial themselves. So we believe that investing in improvements to clinical trials themselves is critical, including how we design and conduct them. I also believe that training at all stages of clinical trial design and implementation is important, not just for those who are going to run trials, but also to all urologists because there are great opportunities to engage with our patients and get them involved in clinical trials. Just briefly want to highlight the folks at University of Michigan, my co-authors, and our funders for supporting our work.
Ruchika Talwar: Thanks so much. I think a lot of the numbers that you bring up really allow us to quantify what a significant number of patients are touched by clinical trials and the clinical trials process. You referenced areas for improvement, so let's dig in a bit there. In your mind, what are the biggest areas that we as a field should focus on in terms of quality improvement in both trial design, trial enrollment, and trial execution?
Kristian Stensland: It's a great question, and that's really the focus of a lot of my work and where my career is headed is trying to identify where some of these barriers to specifically enrollment come from. I think there are a lot of different areas to focus on, and I think the biggest thing honestly is just that there are not that many people who are looking at why clinical trials are not successful and looking for areas of improvement. So we have this great evidence base that's generated by clinical trials, but we don't have a lot of evidence about clinical trials. So I think there is an increasing amount of emphasis, and we've seen a lot of folks, the SUO, the AUA, ASCO of course, that are supporting training for both trainees and established investigators to just get rooted in clinical trials. I think highlighting some of that just to get people exposed and really raising awareness that clinical trials are important, but also giving funding and training to people on how to roll out these clinical trials is going to be huge and probably the best thing we can do for the next few years.
Ruchika Talwar: So we have a lot of exposure to clinical trials at large academic medical centers, but the issue is that the majority of patients actually get their care at smaller centers closer to home, or they have relationships established with their community physicians. So in your mind, what can we do to instead of bringing patients to large centers, what can we do to bring trials to patients?
Kristian Stensland: Yeah, excellent question. I think this is a big area of focus, particularly so you've seen the expansion of new things like telehealth that has allowed us to bring a lot more care to people where they are. I think one big component that's really important is doing a lot of context assessment, and so figuring out where people are and then meeting their needs so that people can be served by trials better. Some of our own work has looked at the distribution of trials, and we have some work recently that's looking at where some areas, and some populations by extension, are very underserved by trials. There's a great group in Kansas led by Shelly Ellis that's looking at improving access to trials within rural communities and looking at strategies for that. A lot of that is rooted in some pretty good implementation science principles that are looking at context assessment and then identifying barriers and strategies to overcome those barriers so that we can get that care and science out to varied populations, which is really important.
Ruchika Talwar: Yeah, absolutely. So as we wrap up here, what are the big takeaways that you'd like our urologic community to know about clinical trials?
Kristian Stensland: Yeah, I think the biggest thing honestly is just that the Clinical Trials Enterprise is huge, and you don't have to be running a clinical trial to be engaged with clinical trials. I think that making sure we bring up clinical trials whenever possible to potential participants discussing them with our patients, I think patients are much more willing to engage with clinical trials than it seems. A lot of the established literature shows that if we offer enrollment into a clinical trial, the majority of patients are going to accept. I think they're very interested in helping contribute to science and also receiving many of the benefits of trials if we're just willing to offer it to them. So I would recommend learning about clinical trials and offering and engaging whenever possible, and I think we can make a lot of progress together.
Ruchika Talwar: Absolutely. I couldn't agree more. Thanks for sharing your expertise with us today.
Kristian Stensland: Thanks again so much for the invitation. Always a pleasure.
Ruchika Talwar: To our UroToday audience, thanks for joining us. We'll see you next time.
Ruchika Talwar: Hi, everyone. Welcome back to UroToday's Health Policy Center of Excellence. As always, my name's Ruchika Talwar, and I'm a urologic oncologist at Vanderbilt in Nashville, Tennessee. Today, I'm excited to be joined by Dr. Kristian Stensland, who's an assistant professor of urology at Michigan Medicine. He'll be chatting with us today about some recent work that he published in urology practice about the size and scope of urologic oncology clinical trials. Dr. Stensland, thanks for joining us.
Kristian Stensland: Yeah, thanks so much for the invitation. Happy to be here and chat about our work. So yeah, thanks so much for the opportunity to present our work. I'm going to give us a brief intro and overview of where our work came from and what we were looking at. Again, as you mentioned, we've looked at the size and scope of the Urologic Oncology Clinical Trials Enterprise, and I always kick [inaudible 00:00:50] off by saying I have no financial disclosures, but do have some funding from the NIH for this work. Anytime I talk about clinical trials, I always want to highlight clinical trialists as well as participants in clinical trials because clinical trials are a huge amount of work. So I always want to show appreciation and respect to everyone who's involved in trials, from level of funders and regulatory agencies, all the way down to our patients and clinical trial participants. Anytime we start talking about clinical trial failure, I think the importance here is that we want to focus on future improvement, not to indict those who are involved in trials.
With that kind of a preamble, I did want to talk about estimating the size and scope of Urologic Oncology Clinical Trials Enterprise, which was recently published in Urology Practice. Again, I want to recognize my co-authors for their help in this work. Really, the preamble to this or the principal question behind this paper was why should any and all urologists care about clinical trials? There's theoretical benefits of clinical trials being important to advance science and trials really underpin a lot of our guidelines and help us direct our clinical care. But a question that comes up frequently is, are there really that many urology patients who are involved in trials and why should this apply to people who maybe aren't running their own trials or designing their own trials? So we sought to answer this question of how many urologic oncology patients there are who are actually involved in trials so that we can contextualize that compared to other things that we're examining. So to answer this question, we accessed all phase two to three interventional urologic oncology trials that were registered on clinicaltrials.gov since 2007.
This was when there was an FDA amendment act as well as some other legislation that required clinical trials to be registered, which is why this specific date pops up in the literature quite a bit. Then we calculated the cumulative actual enrollment for either completed or terminated trials and the anticipated enrollment for trials that are still ongoing, so I haven't read out the results yet. What we found was we identified almost 11,000 total trials, of which almost 5,000 were completed, about 1,500 were terminated, meaning they were closed before they reached an anticipated endpoint, and there are close to 4,500 that are ongoing. But to those that were completed or terminated, meaning no longer enrolling patients, there are about 473,000 urologic oncology patients enrolled. Then for the trials that are currently ongoing, there's almost 600,000 participants that are needed to complete all of those spots. So putting those results in context, that means that there are over 100 patients, 107 participants on average, that are enrolled every day into a urologic oncology trial.
This means that over the course of the year, there are about 28,000 urologic oncology patients enrolled into a trial, which means there are more urologic oncology trial participants per year than there are new cases of testicular, penile, or ureteral cancer combined. There are unfortunately fewer participants who are enrolling per year over time. So when we bunched this out by year, within the last five years, there are fewer patients than there were the years, five years before that and the five years before that. So unfortunately, enrollment does seem to be decreasing, at least on a per trial basis.
So our conclusions from this are that there are many urologic oncology patients that are impacted by trials, not just from the results of them, but also from the conduct and implementation of the trial themselves. So we believe that investing in improvements to clinical trials themselves is critical, including how we design and conduct them. I also believe that training at all stages of clinical trial design and implementation is important, not just for those who are going to run trials, but also to all urologists because there are great opportunities to engage with our patients and get them involved in clinical trials. Just briefly want to highlight the folks at University of Michigan, my co-authors, and our funders for supporting our work.
Ruchika Talwar: Thanks so much. I think a lot of the numbers that you bring up really allow us to quantify what a significant number of patients are touched by clinical trials and the clinical trials process. You referenced areas for improvement, so let's dig in a bit there. In your mind, what are the biggest areas that we as a field should focus on in terms of quality improvement in both trial design, trial enrollment, and trial execution?
Kristian Stensland: It's a great question, and that's really the focus of a lot of my work and where my career is headed is trying to identify where some of these barriers to specifically enrollment come from. I think there are a lot of different areas to focus on, and I think the biggest thing honestly is just that there are not that many people who are looking at why clinical trials are not successful and looking for areas of improvement. So we have this great evidence base that's generated by clinical trials, but we don't have a lot of evidence about clinical trials. So I think there is an increasing amount of emphasis, and we've seen a lot of folks, the SUO, the AUA, ASCO of course, that are supporting training for both trainees and established investigators to just get rooted in clinical trials. I think highlighting some of that just to get people exposed and really raising awareness that clinical trials are important, but also giving funding and training to people on how to roll out these clinical trials is going to be huge and probably the best thing we can do for the next few years.
Ruchika Talwar: So we have a lot of exposure to clinical trials at large academic medical centers, but the issue is that the majority of patients actually get their care at smaller centers closer to home, or they have relationships established with their community physicians. So in your mind, what can we do to instead of bringing patients to large centers, what can we do to bring trials to patients?
Kristian Stensland: Yeah, excellent question. I think this is a big area of focus, particularly so you've seen the expansion of new things like telehealth that has allowed us to bring a lot more care to people where they are. I think one big component that's really important is doing a lot of context assessment, and so figuring out where people are and then meeting their needs so that people can be served by trials better. Some of our own work has looked at the distribution of trials, and we have some work recently that's looking at where some areas, and some populations by extension, are very underserved by trials. There's a great group in Kansas led by Shelly Ellis that's looking at improving access to trials within rural communities and looking at strategies for that. A lot of that is rooted in some pretty good implementation science principles that are looking at context assessment and then identifying barriers and strategies to overcome those barriers so that we can get that care and science out to varied populations, which is really important.
Ruchika Talwar: Yeah, absolutely. So as we wrap up here, what are the big takeaways that you'd like our urologic community to know about clinical trials?
Kristian Stensland: Yeah, I think the biggest thing honestly is just that the Clinical Trials Enterprise is huge, and you don't have to be running a clinical trial to be engaged with clinical trials. I think that making sure we bring up clinical trials whenever possible to potential participants discussing them with our patients, I think patients are much more willing to engage with clinical trials than it seems. A lot of the established literature shows that if we offer enrollment into a clinical trial, the majority of patients are going to accept. I think they're very interested in helping contribute to science and also receiving many of the benefits of trials if we're just willing to offer it to them. So I would recommend learning about clinical trials and offering and engaging whenever possible, and I think we can make a lot of progress together.
Ruchika Talwar: Absolutely. I couldn't agree more. Thanks for sharing your expertise with us today.
Kristian Stensland: Thanks again so much for the invitation. Always a pleasure.
Ruchika Talwar: To our UroToday audience, thanks for joining us. We'll see you next time.