Conducting infectious disease trials in low-income countries is more than important; it is vital if we want to close the gap in global health. These are the regions hit hardest by diseases like malaria, TB, and HIV, yet they’re still underrepresented in trials. That gap doesn’t just slow down innovation; it limits the impact of vaccines and treatments where they’re needed most.

The Importance of Clinical Trials in Low-Income Countries

Low-income countries tend to be underrepresented in clinical research. According to the 2024 Access to Medicine Index, less than half of industry clinical trials involve low- or middle-income countries (only 43% included LMICs), and an even smaller share occurs specifically in low-income countries (about 3.5%). This gap quite obviously means populations miss out on early access to life-saving innovative treatments that are underrepresented in data on new therapies.

It is not only a question of equity. Without data from these settings, we are missing key information. Patterns of disease, underlying health conditions, environments, and healthcare systems vary widely between regions. Additionally, the necessity for diversity in inclusion in clinical trials, as well as genetics and immunogenicity, affects vaccine effectiveness against specific strains.

Global Health Context in Low-Income Countries

Malaria: According to the WHO, malaria accounts for over 250 million cases annually worldwide, and over 94% of cases occur in the WHO African region (WHO Malaria Fact Sheet).

HIV/AIDS: In 2023, an estimated 39.9 million people were living with HIV globally. Sub-Saharan Africa, which includes both low- and lower-middle-income countries, remains the most affected region, accounting for approximately 65% of all global cases (UNAIDS Global HIV Statistics and Factsheet).

This isn’t new information, but it’s still important, these are the regions where the burden is highest, and yet, many of the trials for treatments and vaccines for infectious diseases are conducted elsewhere.

When trials are run elsewhere, it’s harder to know if the results will translate. Different settings mean different comorbidities, different health systems, different risks. Running the research locally gives you data that’s more rooted in the actual context, and that makes it more useful, not just for regulators, but for the people the intervention is meant to help.

Key Challenges in Conducting Trials in Low-Income Countries

There is a strong consensus that more infectious disease trials should be conducted in low-income countries. However, practical challenges on the ground can slow progress. That’s why having a trusted partner to help navigate complex environments is key. For over 25 years, our team has been supporting sponsors in successfully planning and executing their trials.

Varied Infrastructure

Infrastructure can vary greatly across the continent. Some clinical sites are located in areas with unstable power or communications access, varied laboratory infrastructure, and potentially difficulty for the participants to access the site. But this is not the full picture. There are also high-performing, well-established sites across Africa that meet global trial standards.

Regulatory Complexity

Each country’s regulatory and ethics review processes are different. Timelines, documentation formats, and communication styles vary. It can feel unpredictable. But with decades of experience navigating local requirements and supporting harmonization efforts across the continent, P95 works closely with ethics boards, regulatory authorities, and ministries of health to move trials forward efficiently.

Recruitment and Trust

Recruitment takes more than showing up with a protocol. In many low-income settings, people haven’t had much contact with clinical research. Trust isn’t a given. Some communities remember negative experiences; others have heard rumors and both matter. If people aren’t sure what the trial is or why it’s happening there, they may say no. Sometimes they say yes, but drop out later.

Understanding the study is another element. If the consent process is rushed or poorly translated, participants may not really know what they’ve agreed to. That’s a problem, ethically and practically. Then there’s access. Getting to the clinic might mean losing a day’s pay or leaving kids at home. If transport isn’t reliable, people just won’t come. Even small costs add up fast when money is tight.

You can’t fix this with a flyer. Engagement has to start early. Local teams need to lead it. The language has to make sense. People need space to decide for themselves, with no pressure. If that part isn’t done well, recruitment stalls, and retention usually gets worse.

Opportunities in Low-Income Country Trials

The barriers are there, but so are the openings. In many low-income settings, the research environment is changing in ways that matter.

Partnerships

The right-fit partnerships don’t just get trials off the ground; they create systems that stay in place long after the study has concluded. Organizations like The Global Fund, Gavi, and the Gates Foundation (to mention just a few) are putting money and resources into vital research infrastructure.

Technological and Digital Advancements

Accessibility to technology, means that in some studies, follow-up visits are handled by phone or through basic mobile apps, while in others, a simple text message is enough to check in or send reminders. These tools by no means replace on-site care, but they help fill the gaps, especially in places where the nearest clinic might be hours away.

This kind of connectivity is changing the field in remote locations where access to healthcare facilities is limited or particularly challenging. In 2023, the International Telecommunication Union (ITU) reported that over 63% of people now in Africa own a mobile phone, providing a tool to extend clinical trial oversight to areas that would otherwise be difficult to reach.

Local Capacity

One of the biggest shifts is the growth of local research teams. When trials are staffed by people who know the community, things tend to run better. Recruitment improves, communication is clearer, and the trial is more likely to stay on track. That only works if there is a long-term investment, not just training for one study but building roles and systems that last.

Final thoughts: Conducting infectious disease trials in low-income countries

Running infectious disease trials in low-income countries certainly comes with challenges, as we’ve seen throughout this article. Yet, those known and to-be-expected challenges don’t represent any real reasons not to conduct the work. When trials are done well in these contexts, the data is stronger. It reflects real disease patterns, real system constraints, and real outcomes. That’s the kind of evidence global health actually needs, especially for infectious diseases.

At P95, we have spent years navigating these environments. We’ve worked in systems under strain and still delivered what regulators, policymakers, and funders need to move forward. If your next study is heading into Africa or another LMIC, we’re ready to support it, start to finish.

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