In Kenya, toxicologists and epidemiologists face a difficult choice: to pursue better-paid work to support their families, or volunteer as reviewers for vaccine clinical trials, often without the compensation needed to cover even their children’s school fees.

Their dilemma underscores a broader challenge in Africa’s clinical research ecosystem. Slow, duplicative approval processes and limited regulatory capacity continue to deter sponsors from bringing trials to the continent. The continent accounts for 25% of the global disease burden, but just 4% of clinical trials. 

This “stark disparity” means that access to vaccines, diagnostics, and medicines is “not always guaranteed,” said Caxton Murira, a clinical research expert with the Science for Africa Foundation. 

Yet the continent also represents “enormous untapped potential” for the creation of effective and ethical medicines and vaccines, said Angelika Joos, science and regulatory policy executive at  Merck, and a panelist at the fourth and final event in a series at the annual Africa Regulatory Conference. 

“Africa is critical for advancing science and for ensuring that medicines work for everyone,” she said, addressing the recent webinar, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The four-part online conference focused on patient and community engagement, under-represented populations, innovative designs, and lastly, streamlining regulatory processes. 

Creating incentives for reviewers is one of the many ways experts have proposed to improve the continent’s regulatory system for clinical trials. To draw more clinical trials to Africa, panelists urged countries to  harmonize, simplify, and accelerate approvals for regulatory and ethics approvals across the continent. 

A ‘mismatch’ in the R&D pipeline

At the heart of the problem is chronic underinvestment. Funding for clinical research and development does not reflect Africa’s burden of disease, Murira noted. This gap spans both infectious diseases, such as malaria and tuberculosis, and noncommunicable diseases (NCDs) like diabetes and heart disease, which are rising as Africa’s population ages.

And while many countries have made significant progress in reducing infectious diseases, NCDs are often neglected in clinical research and trials, Murira argued. 

Globally, clinical trials exceeded $84 billion in market size in 2024, with every dollar invested in clinical research yielding a $405 return. Yet only 4% of the roughly 25,000 trials that occur each year take place on the African continent. 

This mismatch, driven by global market and industry strategies rather than local disease burden, jeopardizes the future of new medicines and demonstrates the chronic underinvestment in the continent’s healthcare ecosystem.  

Experts pointed to capacity fragmentation, poor visibility of resources, and a time-consuming regulatory process as worsening Africa’s clinical trial under-representation. Many countries can host clinical trials – beyond the usual hubs where funding is typically concentrated to such as South Africa, Egypt, Nigeria, Kenya, Ghana, and Tanzania. However, lesser-known sites struggle to compete with established centers.

Networks for collaboration

To enhance this visibility, the South African-based start-up, nuvoteQ, has set up an interactive online platform called the Clinical Trials Community (CTC) Africa. 

CTC aims to attract investment in African clinical trials by showcasing the continent’s clinical trialists and research sites, said CEO Adriaan Kruger. 

It is an “interactive platform” that provides a registry of sites, data on site feasibility, and access to country-specific regulatory and ethics information to make it easier for sponsors to find and partner with African research locations. 

“We actively work on providing and building a financially sustainable model so that we can keep these platforms running in the long term,” said Kruger, noting that past initiatives have failed to gain traction.

Efforts to enhance visibility and partnerships are already underway regionally. The Science for Africa Foundation, headquartered in Nairobi, has mapped over 3,500 clinical trial centers, regulatory boards in 55 countries, and 196 ethics committees. The goal, Murira said, is to improve visibility while highlighting gaps that need investment.

“We’ve shifted from asking, ‘What’s your research capacity?’ to ‘How can we use what you have to position you to be a leader on the African continent?’” said Murira, who heads the foundation’s clinical trials and research portfolio. 

Standardizing the process 

Aside from finding suitable sites for trials, researchers or pharmaceutical companies looking to recruit patients into clinical trials find that the approval process can be duplicative, ineffective, and expensive, said Joos. 

These delays hinder patient access to innovative treatments, and deter researchers from attempting more trials.

Bioethicist Keymanthri Moodley, an emeritus professor at Stellenbosch University, highlighted the lack of standardization – and trust – between research approval boards as impeding the process. 

“One research committee does not trust the competency of another,” Moodley argued. So if malaria vaccine researchers wanted to recruit participants across a national border, they could run into months-long delays for approvals from both countries. Furthermore, both researchers and reviewers are in need of training. 

“We have the tools but we need standardization,” said Moodley, pointing to World Health Organization’s (WHO) Global Benchmarking Tool (GBT) as a helpful metric for evaluating national regulatory authorities (NRAs). 

“There has been so much development at the theoretical level. But the area where we experience challenges is implementation. The continent is heterogeneous. Every country is different, but in general, very few resources are allocated to regulatory authorities and research ethics committees. And so we were always complaining about delays in regulatory approval,” said Moodley, who also served as founding director of a WHO Collaborating Centre in Bioethics.

David Mukanga, deputy director for Africa regulatory systems at the Gates Foundation, echoed these concerns, saying that as research ethics committee members are not paid to review trials, they are placed in a difficult position. 

“If you review 30 protocols in five years, it doesn’t count towards your promotion,” he said. But supervising a PhD student does.” 

This leaves academics juggling teaching loads, exams, and financial pressures while trying to support essential ethical reviews. 

“There needs to be creative incentives for people to be able to commit time and be recognized for their good work in supporting reviews,” he said.

Reducing duplication through regulatory reliance

One solution gaining attention is regulatory reliance – the concept that one country’s drug regulator uses the scientific assessments of another trusted authority. This, in turn, could reduce redundant reviews and shorten approval timelines.

“Leveraging trusted national regulatory assessments reduces duplication, speeds approvals, and fosters collaboration,” said Lada Leyens, a senior director at the pharmaceutical company Takeda. 

The UK’s medicines regulator recently introduced a clinical trial reliance pathway allowing approvals within two weeks when a trusted authority has already assessed the application, Leyens noted. For under-resourced African regulators facing staff shortages and high turnover, reliance could significantly shorten timelines.

Africa’s future

For those working to improve the clinical research and trials ecosystem in Africa, enhancing the visibility of capacity, fostering trust between researchers, regulators, sponsors, and the community, and increasing investments in ethical clinical trials in Africa all remain critical goals. 

“We need to build the capabilities now and the capacities now to position Africa as a key player in the next decade of this global health innovation. It’s about equity, it’s about scientific progress, and it’s about preparing Africa for the future,” remarked Joos. 

The webinar, Streamlining regulatory and ethics approvals, was the fourth of a four-part online African Regulatory Conference hosted by IFPMA. All four sessions were recorded and available for viewing.

Image Credits: Eugene Kabambi/ WHO, IFPMA.