“Expanding Access Isn’t Just About Fairness—It’s About Building Better Treatments for Everyone”

Global health has seen plenty of upheaval in recent weeks. First came news that the United States is severing ties with the World Health Organization (WHO). Then came the decision by the Trump administration to all but shutter the US Agency for International Development (USAID), which brought at least 30 international clinical trials to a sudden halt.

All this provided an ironic backdrop for Regina Barragan-Carrillo, MD, a postdoctoral fellow at City of Hope Comprehensive Cancer Center, who this week presented results that show clinical trials in renal cell carcinoma (RCC) mostly take place in wealthy countries, even though poverty is strongly linked to poor outcomes in this disease. Barragan-Carrillo presented her findings at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), held February 13-15, 2025, in San Francisco, California.

ASCO, as well as the National Cancer Institute and the FDA, have called for both academic investigators and pharmaceutical companies to take steps to ensure that clinical trial enrollment for new therapies more closely matches the population of patients who will take the drugs. But data show it’s been an uphill battle. The Lazarex Foundation reported in 2024 that Black patients make up 5% of clinical trial participants, although they are 13% of the US population, and Hispanic patients are only 1% of trial participants even though they are 16% of the population.

Regina Barragan-Carrillo, MD | Image credit: ASCO

Barragan-Carrillo’s study focuses on a key problem: too many studies don’t go where the patients are. The American Journal of Managed Care^® (AJMC^®) spoke with Barragan-Carrillo in San Francisco during ASCO GU about her findings and their importance, given the shifting landscape over support for diversity and equity initiatives in health care.

This interview has been lightly edited for clarity.

AJMC: What do we know about the connections between RCC and poverty?

Barragan-Carrillo: We know that lower socioeconomic status is linked to both a higher risk for developing RCC and worse survival outcomes. And these survival outcomes are dependent on later diagnosis and worse access to care, as well as less access to novel systemic therapy.

For example, here in the US, Black patients [with RCC] have a 16% higher mortality rate compared with their non-Hispanic White counterparts. In Arizona, when we’re talking about patients from Latino origins, it's been documented that these patients are twice as likely to be diagnosed in advanced stages and have nearly double the risk of dying from early-stage disease compared with non-Hispanic White patients.

This does not stop at the individual-patient level. On a global scale, people that come from lower-income face even greater barriers to care, with 5-year survival rates up to 50% lower than in wealthier countries. There definitely is an important risk, not only from a biological standpoint, but more from contamination and exposure to environmental factors that could increase the risk for developing the RCC. Access to care also plays a very important role.

AJMC: Your findings show that 76% of the trials in RCC were conducted exclusively in high-income countries and that none were available in low-income countries. Beyond the fact that the trials fail to reflect racial and ethnic diversity, what knowledge do we lack about drug delivery in low-income countries when we fail to include them in trials?

Barragan-Carrillo: So, what do we not learn about that process when we don't do the trials in low-income countries? We do not learn a lot, to be quite frank with you, when these trials are not conducted in all sorts of backgrounds. In low-income countries, we are missing critical information about how the treatments work in the real-world setting, but also how drug distribution works.

For example, how do we ensure that hospitals have the right capability to handle the drug, to have the correct refrigeration system to ensure the quality of the drug is going to be maintained; that it [matches] the quality when they were doing the research in high-income countries. The fact that we're not annotating for that, and we don't have the evidence to support it, also leads to fewer opportunities to improve it.

It's going to be very hard to have specific steps to improve the quality of care, even for patients who are living in remote areas of the US. We’re missing out on a lot of critical information.

AJMC: What are some other challenges with drug delivery that we could learn about during a clinical trial?

Barragan-Carrillo: Many patients in [low-to-middle-income countries] have coexisting conditions, such as malnutrition, parasitic infection, or environmental exposures, that do not happen in high-income countries that could alter the drug’s effectiveness. It’s hard to pinpoint a single thing, but the one sure thing is that populations do look very different across the US and across the globe—so all these external factors that are seen more often in other countries are not being shown in the clinical trials. And we're not sure if the interventions that have proven to be effective for patients living in high-income countries are going to be as effective for patients living in other regions of the world.

AJMC: Your results highlight the disproportionate role that pharma plays in funding trials. Almost all the time, pharma sponsors trials for their own investigational drugs—not for generic drugs that low-income countries would be more likely to afford. Whose job should it be to maintain the infrastructure to pay for those kinds of studies?

Barragan-Carrillo: That’s the million-dollar question, to be completely honest. Right now, no one is really taking ownership. If I can be very transparent, pharma companies clearly do focus on the profit and the patent in drug trials, meaning they rarely invest in trials for generics. And even though generics could be game changers for low-income countries, it's something that does not have an economic interest where we ask ourselves, “Who should be the one stepping up?” It has to be a collaborative effort.

First, governments must take a more active role, particularly through public health care agencies and funding bodies and international agencies. For example, the WHO should step up to help coordinate the effort and establish funding mechanisms. [Nongovernmental organizations] have a role to play, especially in implementation; patient advocacy and public and private partnerships can offer a way forward, pairing the infrastructure and expertise from the industry with the public sector funding and global priorities.

An important example that I love to highlight is the Drugs for Neglected Diseases initiative. It’s a very good model, in the sense that it brings together different stakeholders to fund research on diseases that are disproportionately affecting low-income regions. We need to do something similar in the space of not only RCC, but oncology in general to help patients worldwide.

AJMC: Why should it matter to wealthy countries for poor countries to have access to clinical trials? How does everyone benefit when everyone has access?

Barragan-Carrillo: First, I think of fairness. Cancer is just not a problem of wealthy countries, so why should clinical research be concentrated there? If we test new therapies only in high-income settings, we end up with treatments that may not be applicable, accessible, or even effective in a large portion of the world's population.

Right now, we're overwhelmingly concentrated in high-income countries, which is leaving out the majority of the world's patients who have cancer; 70% to 75% of all new cancer cases are happening in lower- and middle-income countries, so we're talking about almost three-quarters of our worldwide patient population. And expanding access isn't just about being fair; it’s also about making treatments better, stronger, and more effective for everyone.

Beyond equity, there are scientific benefits to expanding clinical trials globally. Genetic diversity matters, and it matters a lot in oncology. It matters a lot when you talk about pharmacodynamics and pharmacokinetics; the way patients respond to different cancer treatments can vary a lot on the genetic background, environmental exposures, and underlying health conditions. Including low-income countries in trials gives us more representation on data, and it leads to better and more universally effective treatments.

Another thing I’d like to mention is that we learn how to make treatments in health care environments. Not every country is going to have the same access to high-tech imaging, robotic surgery, or expensive immunotherapies. Understanding how to adapt the treatments for different levels of health care infrastructure can help make them more scalable and more accessible worldwide.

AJMC: So, we might actually learn how to do things in a less expensive way?

Barragan-Carrillo: Yes, 100%. There’s what we call reverse engineering, where we learn how to adapt certain information in a lower-income setting and then we bring it back to a higher-income setting to be more much more cost-effective. That can allow patients to have access to are without so much financial toxicity.

AJMC: Obviously, you were working on this study for a long time. But you happen to be presenting these results just as the new administration is pulling back on personnel, on funding that supported a lot of this kind of research, and on the infrastructure that supported this work. Many of these decisions, of course, are being contested. What are the implications of presenting your research now, in this changing environment?

Barragan-Carrillo: I think scaling back this type of funding, it's a major step in the wrong direction. From a scientific point of view, cutting funding from whole global health research doesn't just slow down the progress, it actively worsens these priorities. The broader implications are quite concerning. It could mean less innovation….

This could lead to worse patient outcomes. If trials only happen in wealthy regions, we'll continue to see major inequities in who benefits from scientific answers. It leads to a weaker international collaboration, which not only has an impact on health care, but also an economic and social impact.

Global health efforts rely not only on partnerships, they also rely on collaboration between groups and between countries. So, when the funding disappears, these partnerships end up breaking down. Rebuilding them is going to take years. At a time when we should be looking at expanding clinical trial access, these cuts do the exact opposite—by shrinking opportunities, limiting research, and ultimately costing lives.