From the newsletter
Africa bears 25% of the global disease burden but hosts just 1.1% of global clinical trials, leaving millions without access to emerging therapies. In an exclusive interview with Healthcare Rising, Dr Henshaw Mandi, a senior epidemiologist at Coalition for Epidemic Preparedness Innovations (CEPI), explains that this exclusion delays drug availability and limits local manufacturing.
“You can’t talk about local manufacturing without clinical trials. Trials are where production begins, you need to manufacture small batches to test. If we’re not doing trials here, we’re not part of the value chain. Manufacturing must start with African-led research on African soil.” he adds.
As Africa faces rising climate-linked health threats, its exclusion from global clinical trials limits access to life-saving innovation and undermines efforts to build resilient, responsive health systems.
More details
Why are clinical trials important for Africans, and for Africa’s pharmaceutical development?
Clinical trials are essential for public health because they are the only way to test whether a medical product, be it a drug, vaccine or device, is safe and effective for people. You can’t give a product to a population without scientifically proving its effects. Beyond the health benefits, trials help build critical systems: they create jobs, train professionals and stimulate local manufacturing.
For Africa, clinical trials also represent ownership. Historically, our role has been limited to providing blood samples and data that are shipped abroad and then buying back expensive finished products. That’s extractive and unsustainable. We want to develop our own diagnostics, vaccines and treatments. Conducting trials locally ensures the products we develop are truly relevant to our populations and gives us control over our healthcare future.
How do clinical trials work and what are the key phases?
A clinical trial typically follows a structured process. Before any human testing, the product goes through pre-clinical studies, usually on animals, to determine its safety and biological activity. Once that’s cleared, regulators may approve trials in humans, which occur in four phases.
Phase 1 tests the product on a small number of people to assess basic safety. Phase 2 involves more people to start evaluating effectiveness. Phase 3 is a much larger study to confirm both safety and efficacy across broader populations. If successful, the product can then be submitted for licensing. Sometimes there's a Phase 4, which looks at how the product performs in real-world conditions after approval.
Trials also drive early manufacturing, small batches are produced for testing, which builds local capacity. They create opportunities for communities to participate in innovation and improve public trust in the final product.
Does Africa currently have the capacity to run clinical trials?
Yes. Africa does have capacity, but it is unevenly distributed. Countries like Kenya, South Africa, Senegal and Egypt have well-established clinical trial infrastructure. Rwanda is also making strong progress. Kenya, for instance, is involved in major trials like the new tuberculosis vaccine and long-acting HIV treatments.
However, only a few out of 55 African countries have this maturity. We need to decentralise these capabilities and ensure more countries participate, so that we can test across diverse settings and populations. Clinical trials require specialised infrastructure, trained professionals, and strong regulatory support, all of which exist in some places, but not everywhere.
The issue isn’t just technical; it’s also political and financial. To expand capacity, we need investment in training, infrastructure and coordinated policies across countries.
What major gaps still hinder clinical trial growth in Africa?
Several gaps persist. First, human resources: we don’t have enough trained professionals. We need more clinical researchers, trialists, and regulatory experts. Second, regulatory maturity is low in many countries. Less than 10 countries have strong enough systems to efficiently review and approve trial protocols. Third, local investment is weak, most funding comes from outside Africa, which limits ownership and relevance.
Another major issue is fragmentation. Countries operate in silos, with different regulatory processes, timelines and approval criteria. This makes it hard to run multicountry trials or scale innovation. For example, a trial approved in Nigeria may not be accepted in Kenya because their processes are different.
That’s why the African Medicines Agency (AMA) is a game-changer. It's being developed to harmonise regulatory processes across Africa, so if a product is approved through AMA, it could be used in all member states. That would speed up access, reduce duplication and attract more investment in African research and development.
Why is it important to test health products across Africa’s diverse populations?
Africa is one of the most genetically, culturally and geographically diverse continents on the planet. What works for one group may not work the same way for another. So if we only test in one country, one tribe, or one city, we miss out on vital data and may even develop products that don’t benefit everyone equally.
For example, Kenya has 47 counties and each has unique demographics. The people of Kisumu differ from those in Nairobi or Mombasa. Similarly, Tanzania’s Mwanza is different from Dar es Salaam or Arusha. Nigeria alone has over 500 ethnic groups. If we’re not testing across this diversity, we’re failing to capture real-world variability in treatment outcomes.
Diversity in clinical trials ensures that when a product reaches the market, it’s effective and safe for the people who need it. It also strengthens equity, giving all communities a stake in medical innovation.
What is the issue with clinical trial fee standardisation in Africa?
There is no unified fee structure for professionals involved in clinical trials across Africa and that’s a problem. For instance, clinical research associates (CRAs), the people who monitor and support trials, may charge very different rates even for similar work. In Kenya, one might ask for $10/hour, while in Tanzania it could be $50/hour.
This inconsistency undermines the value of African professionals and creates confusion for sponsors. It also allows exploitation: when fees are too low, it’s assumed the person may not be competent or experienced. On the other hand, high fees without justification can scare away funders.
If we develop standard benchmarks or guidelines, not to fix everyone at the same rate, but to define fair, experience-based ranges, it could uplift the profession. Junior staff would know what to expect and senior professionals could negotiate based on merit. Standardisation adds credibility and encourages sponsors to treat African trial sites with the seriousness they deserve.
What impact could standardised fees have on the value of clinical research in Africa?
Standardised fees would signal that African professionals know their worth and are organised. It would remove the guesswork and raise the profile of clinical researchers. When a sponsor sees a consistent, transparent structure, it builds trust and respect.
It also opens a clear pathway for career growth. For instance, a junior CRA might start with a benchmark rate of $25/hour. With training and experience, they could move to $50 or $75/hour as a senior. This clarity encourages people to stay in the profession and improve their skills.
Ultimately, it's about building value and dignity into African clinical research. If we want to lead our own health future, we must ensure our professionals are respected, fairly compensated and supported to grow.