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Ashish Kamat: Hello, everybody, and welcome to UroToday's Bladder Cancer Center of Excellence. I'm Ashish Kamat, Professor of urologic oncology, and it's a pleasure to welcome to our forum, doctor Koral Shah, who is a first-year hemonc fellow at the City of Hope Comprehensive Cancer Center.

Koral, thank you so much for taking the time and joining us today. We're really interested to hear what you presented at ASCO GU this year on this very important topic, because it's so relevant to everything that we do, not just in the United States, but of course globally, right now worldwide, and in different countries, different health care systems. So really excited to hear what you have to say, and then your thoughts on the worldwide disparities in bladder cancer clinical trial availability.

Koral Shah: Of course. Thank you so much for having me. It is an honor to be here today. Yes, so very quickly I can definitely review my abstract. So we evaluated the worldwide disparities in bladder cancer clinical trial availability. And for the sake of time, we will just gloss over the methods. But I do have them available if we do want to discuss.

And so a little bit as to the how and why we did this project. So with the help of a wonderful research team at City of Hope, we scoured the National Clinical Trials database and identified all bladder cancer trials from 2019 to 2024. We then took down their clinical trial characteristics, and we also looked at nearly every country in the world and categorized them based on income classification by World Bank ranking.

And we used all this information to assess the association of trial availability, and what specific characteristics are associated with which World Bank ranking. And the reason for all of this is, given all of the obstacles that stand in the way of conducting clinical trials in non-high-income countries, I wanted to see if there was any specific type or trial characteristic really lacking in the bladder cancer space.

And a bit of terminology with World Bank ranking in terms of this abstract in the paper: I am considering high-income countries. I'll call them high-income countries, and the rest will fall under non-high-income countries.

And a bit of background. Bladder cancer poses a disproportionate burden on non-high-income countries, specifically a mortality burden. And so you can see here on the left in the yellow, the top 10 countries with the highest incidence of bladder cancer—90% of those are high-income countries. Whereas on the right, the top 10 countries with the highest mortality of bladder cancer, only 40% of those are high-income countries. So you are already seeing that disproportionate mortality burden.

Going right into our results—to no one's surprise, we confirmed that World Bank ranking is significantly associated with clinical trial availability. What that means is countries with a higher World Bank ranking will have a higher probability of having a bladder cancer trial. And for example, in our study, we had zero bladder cancer trials in low-income countries.

Looking at all of our results, we had 539 trials that spanned 63 countries, meaning most countries did not have a bladder cancer trial. And of these countries, about 61% of them were low-income or low–middle-income countries.

This is a bar graph of the top 20 countries that were most involved in the 539 trials we looked at. You can see that the US dominates most of the bladder cancer trials. And going back and looking at the very high mortality countries, Poland and Egypt were the only two countries that made it onto this top 20 list.

Other ways of looking at the results: high-income countries have a higher incidence of bladder cancer, whereas non-high-income countries have a higher mortality of bladder cancer. And in the bottom right corner, that's our data. Of the 539 clinical trials we looked at, 79% of them were only within high-income countries. And of that, half were in the United States alone

A bit about the trial characteristics as well. So the main takeaways here are that trials in non-high-income countries are mostly sponsored by academia, they have less pharma funding, they're less early phase, and they have larger planned enrollment.

In summary, we are lacking early-phase trials in non-high-income countries, creating a gap in safety and efficacy testing for diverse populations. And if we can focus on expanding early-phase and pharma-funded studies in these settings, this would be a method of progressing towards equitable care for bladder cancer.

And a thank you to UroToday and doctor Ashish Kamat, but also my wonderful City of Hope team.

Ashish Kamat: Thanks so much, Dr. Shah. That was very well done and a sobering spotlight on the disparities in clinical trial. So now, tell me a little bit—because when we look at the data, such as what you presented, it is sobering.

And of course, one of the things that we do, for example, through the International Bladder Cancer Group is try to address these disparities when it comes to guidelines and recommendations for patients and health care systems across the globe. So it's something that we are acutely aware of and trying to help solve through our organization. And I'm sure you worked with doctor Powell and others in that same sphere as well.

But at the same time, when we do this kind of work, we also see that there is a lack of clinical trials in that particular country or region. But what is the cause behind it? Were you able to drill down and see? Was it a perceived lack of infrastructure? Was it a perceived lack of quality control? Were there any metrics that you were able to look at and/or any insights that you have, even if you couldn't look at it in the abstract?

Koral Shah: Yeah, of course. That's a great question. So ASCO in 2024 actually released a policy statement basically urging clinicians and scientists to try to expand the global equity of clinical trials, and they cited a lot of barriers as to why it's difficult to conduct clinical trials in these areas.

They talked about patient-related issues. Of course, you have mistrust of the medical system in a lot of areas. You have provider-related issues, which is actually huge. There's a huge scarcity of oncology providers, technicians, lab scientists in certain settings. And as you know, as a urologist, bladder cancer is primarily driven by surgery and radiation—or more so surgery in other countries, because those are the resources that we have. And so there's lots of provider difficulties as well.

Also, the infrastructure and government regulatory barriers are huge in those countries. And then of course, finally, the big one is industry is a little bit hesitant to participate in certain areas where there's not a well-defined scientific or laboratory or research infrastructure, because it makes it a lot harder to do research in those areas. So I think it's a combination of all of those.

I will say, focusing on my data specifically, because as you said, I was curious which barriers are we seeing the most. And of course, I haven't been able to go through every single country that hosted a bladder cancer trial to see the exact situation in each of those countries, but we are seeing a definite lack of industry funding and early-phase trials in non-high-income countries. So that is already showing us that is probably the number one barrier.

And an interesting thing—now that I've written up the manuscript and we're working on submission, I've looked at a little bit more data, more trials, and done a more in-depth analysis of clinical trial characteristics. And I've looked at countries that have trials only in high-income countries, trials only in non-high-income countries, and then this middle group—so trials that are happening in both settings. And that, I think, will have some very interesting findings, because you basically have this subset of trials that has a PI based in a high-income country, and you can see how much the clinical trial characteristics will differ based on trials that are done solely in high- or in non-high-income countries.

Ashish Kamat: Yeah. And I'd be excited to see what you're finding from your data. But what we gleaned when we did this worldwide thing—and I and my colleagues have worked in countries such as Chile and of course India and Japan and China—and some of this work that we see is driven, in many ways, with, like you said, the reluctance of the patient to participate in a clinical trial, but also just the realities and the scarcity of manpower. Because to do a well-conducted and annotated clinical trial, there's a lot of hurdles and a lot of steps.

And for the hospital or the physician or the PI to actually meet all those regulatory requirements that then make the data worthwhile—for example, from a pharma perspective, like going for a regulatory approval—there's a lot of boxes that have to be checked, because otherwise all that data will be useless, right? Because patients will have expended their time and energy, which we want to recognize. Physicians will have expended their time and energy. But then it won't meet the metrics.

So I think in some ways, it's almost like there has to be a grassroots effort at the local, regional level, educating, providing funding, essentially echoing what we do here and in developed countries, so that they can develop their own infrastructure. We can certainly help, but until that happens, it's unfair, in some ways, what we tend to do is say, “Oh, there's not enough trials in the low-income countries.” But then we're like, “OK, we're not going to provide you with the solution to it,” right?

So I'm really excited to see what your paper has to shed light on, because ultimately, unless we identify the problems, we can't then provide solutions and call-to-action items and things like that. But really appreciate the work that you and your team are doing. And best of luck with the rest of your fellowship.

Koral Shah: Thank you so much.