How Can Lower-Income Countries Maintain Representation in Clinical Trials?

When considering the entire world, the majority of cancer-related clinical trials occur in the US. Additionally, with region-based genetic disorders in consideration, both the pharmaceutical companies and countries must find ways to ensure trial representation remains prudent.

Syed Osman Ali Ahmed, MBBS, BSc (Hons), MRCP, FRCPath, CCT, discussed this issue in his presentation titled “Global Experience with Cellular Therapeutics”, which was delivered at the 2025 Immune Cell Effector Therapy (ICE-T) Congress.

Ahmed, an attending physician at King Faisal Specialist Hospital and Research Centre in Saudi Arabia, spoke with CancerNetwork® about how some regulations are in place to help mitigate this problem. For example, many countries require a specific number of patients representing the country to be enrolled in a registrational trial for a product to be marketed.

On the part of lower- and middle-income countries, he added that they must act to build trust with pharmaceutical companies, which can range from organizing a clinical trial ecosystem to developing institutions. Additionally, for more expensive and advanced therapies, regulators may need to place pressure on pharmaceutical companies to ensure they enroll a representative patient population in their clinical trials.

Transcript:

Even in the US, for example, there’s now an increasing mandate to have greater ethnic representation. That’s great for the US, but for the rest of the world, let’s talk about higher-income countries and middle-income countries, whether [they are in] the Middle East, the safaris, or Asia. [Regarding] these countries, especially where these therapies may be marketed, many of them—especially in Saudi Arabia—stipulate that if you’re going to market a therapy [in these countries], you should have enrolled patients on those registrational trials. That puts some pressure on industry to come here. A lot of times, there is an invisible barrier for industry to open trials. It doesn’t have to be that way.

The patient populations are here. What needs to be built is trust in the trial ecosystem in any given country. It requires, not a huge amount, but some investment on the part of low- and middle-income countries, especially those that have large populations, to organize the clinical trial ecosystem to make it more attractive for industry to come and say “Look, there are large populations of patients over here who can benefit from this.” That has happened in the field of hepatitis. It’s happened for antibiotics. It’s happened through the antiviral trials. It’s happened for trials for hydroxyurea and sickle cell [disease].

Trials at scale can be conducted in middle-income, low-middle-income, and even lower-income countries if you organize a trial ecosystem. The challenge is to allow that same confidence to be built for more expensive, advanced therapies. That is where there will have to be some regulatory pressure from regulators—not just in these countries, but also in the West—to say, “You have to go across the world and get a more representative enrollment of patients.” There is going to have to be some of that….That’s at the regulator level.

If it’s at an institutional level, we’ve been able [to open trials] through a great team over here in the institution. We [once] weren’t able to get industry or partners to open trials because the timelines were too long; it wasn’t organized enough. It took a bit of effort and a small investment to streamline the processes, to make it quicker, and to make the time to enroll in an opening trial more efficient. Once that happens, and that confidence gets built, you’re then able to open an institution in any given country for trials. Once an industry partner gets confident in an institution in a country, they get confident in the country. Then, they may fan out in that country and in that region. It’s a question of building confidence and trust, and it’s upon industry to take a bit of a risk and see that there is a greater benefit beyond the financial interest. There’s a greater humanitarian benefit that can be obtained by making these innovative trials accessible to more patients.

Reference

Ahmed SO. Global experience with cellular therapeutics. Presented at the 2025 Immune Cell Effector Therapy Congress; September 27-28, 2025; Kansas City, KS.