Africa’s Rising Role in Global Clinical Trials

For years, a statistic has persisted: only about 3% of the world’s clinical trials are conducted in Africa, despite the continent being home to roughly 20% of the global population. However, the COVID-19 pandemic served as a catalyst, forcing a reevaluation of this disparity and highlighting the need for increased clinical trial infrastructure across Africa. A modern initiative aims to dramatically change this landscape, positioning the continent as a key player in global health research.

The Challenge of Fragmentation

The limited capacity wasn’t due to a lack of qualified investigators or willing participants. Instead, the primary obstacle was fragmentation. Dozens of regulatory bodies, varying levels of site infrastructure, inconsistent processes, and limited coordination across 54 countries created significant hurdles for sponsors attempting to conduct trials at scale.

Introducing the Africa Clinical Research Network (ACRN)

Tariro Makadzange, founder and CEO of the Africa Clinical Research Network (ACRN), is spearheading efforts to overcome these challenges. ACRN is designed to create an “always on, always ready” clinical trial platform across the continent, with an ambitious goal: to increase Africa’s share of global clinical trials to 15% within the next decade.

Beyond Manufacturing: Supporting Clinical Development

While acknowledging the importance of local vaccine manufacturing, spurred by the pandemic, Makadzange emphasizes that manufacturing is only one piece of the puzzle. “Even if you do bring in manufacturing, how do you support clinical development?” This question led to the creation of ACRN, a network designed to continuously run trials across various therapeutic areas, enabling rapid activation during future health crises.

Building on Existing Infrastructure and Partnerships

Over the past few decades, investments from organizations like the National Institutes of Health (NIH) have strengthened infrastructure in specific disease areas, such as HIV and infectious diseases. However, broader therapeutic areas like oncology, cardiometabolic diseases, and renal disease remain significantly underrepresented in African clinical research. ACRN recognizes the need for collaboration, stating, “We strongly feel there’s no way we can do it on our own … we need partners.”

ACRN: A Research Platform, Not Just a Network

Established approximately a year and a half ago, ACRN is backed by initial funding from the Gates Foundation and the Ellison Institute of Technology in Oxford. The organization is building a comprehensive “research platform,” not simply a network, to address the complexities of the African regulatory landscape. Africa comprises 54 countries, each with distinct regulatory authorities, varying levels of maturity, and diverse requirements.

De-Risking Complexity for Sponsors

ACRN aims to simplify this complexity for sponsors by building a regulatory intelligence function, directly engaging with national regulators, and aligning with continental initiatives like the African Medicines Agency and the African Free Trade Agreement. These efforts are designed to harmonize processes and reduce fragmentation. The network is standardizing contracting, Standard Operating Procedures (SOPs), and startup processes to accelerate activation and ensure predictability for sponsors.

A Growing and Diverse Applicant Pool

Within six months of launching an expression of interest, ACRN received nearly 600 applications from sites and investigators across the continent. Following a rigorous review process, including visits to over 80 sites in 15 countries, 35 sites were selected for the initial network. This composition is deliberate, with approximately two-thirds being highly experienced sites and one-third being emerging sites with strong patient reach and growth potential. The long-term vision includes a more decentralized model incorporating physician groups and specialist practices into routine care.

Demographic and Economic Opportunities

Africa’s rapidly growing population – representing roughly 20% of the world today and projected to comprise nearly a third of the global population by the conclude of the century – presents a compelling argument for increased clinical trial participation. This growth isn’t just a matter of diversity in drug development. it as well represents a significant economic opportunity.

Expanding Beyond Infectious Diseases

Historically, industry-sponsored trials in Africa have primarily focused on late-phase vaccine and HIV studies. ACRN is working to expand research into broader therapeutic areas, engaging with global pharmaceutical and Contract Research Organizations (CROs) to move beyond traditional infectious disease research. For studies funded by global health organizations, ACRN can provide near end-to-end support, including protocol development, regulatory submissions, feasibility assessments, and site management. For industry-sponsored programs, the organization is exploring partnerships with global CROs to enhance operational capabilities.

A Digital-First Approach

ACRN is leveraging a digital-first approach, building its technology stack from the ground up with support from Oracle. This includes tools for site selection, feasibility studies, Electronic Data Capture (EDC), randomization, and data analytics. The organization is also exploring eSource integration, AI-enabled data query handling, and automation of regulatory writing workflows. This approach minimizes paper-based processes for sites, offers cleaner data flows for sponsors, and potentially accelerates query resolution.

Regulatory Progress and Collaboration

More than 11 African countries have achieved WHO Maturity Level 3 for their regulatory systems, indicating strengthening oversight. The African Medicines Agency is also taking shape under experienced leadership, and trade agreements are reducing barriers. As Makadzange states, “There’s really no good reason why more studies are not being done on the continent.”

A Catalyst for Change

ACRN positions itself as a catalyst, connecting sites, regulators, global health funders, pharmaceutical companies, and CROs. While the 3% figure underscores the current underrepresentation, the 15% target serves as a provocation. Diversifying research capacity is not only a matter of fairness but also a crucial resilience strategy for global health security.