Authors

Lynn Adams, Vice President, Internal Medicine & Dermatology

Jacqueline Sievers, Senior Clinical Project Manager

Expanding clinical trials into Sub-Saharan Africa (SSA) and the Middle East and North Africa (MENA) is essential to advancing drug development. These regions combine high unmet need with opportunities to strengthen diversity, equity and scientific validity in global research. However, delivering trials successfully in these environments requires more than traditional operational models; it’s a deliberate approach to leadership, regional expertise and execution the ability to manage complexity proactively rather than reactively.

Why Africa Matters in Sickle Cell Disease Research

Africa is central to sickle cell disease research because it carries the world’s highest disease burden. As disease-modifying treatments and gene therapies advance, sponsors increasingly recognize that Africa must play a larger role in global programs to generate representative data, broaden research access and reach the communities most affected.

The question is not whether Africa belongs in global sickle cell disease research, but how sponsors can engage the region strategically to strengthen science, execution and patient outcomes.

Including African countries is about more than increasing enrollment, it creates opportunities to generate more representative data, broaden access to research and ensure scientific innovation reaches the communities that need it most. When incorporated thoughtfully, Africa becomes not only a recruitment geography but a strategic component of a globally-representative development program.

The challenge: When complexity becomes the critical path

Clinical trial execution in SSA and MENA is shaped by complexities that directly affect timelines, including:

• Evolving or unpublished regulatory and ethics expectations
• Multi-layered approval pathways across central and local authorities
• Cross-border data transfer and sample movement constraints
• Infrastructure and logistics dependencies
• Geopolitical and high-visibility environments

These factors sit on the critical path and demand a tailored operating model.

From Global Strategy to Country-Level Execution

Global strategy creates value only when translated into country-level execution. In SSA and MENA, success depends on understanding factors that extend far beyond protocol requirements, including regulatory pathways, import and export requirements, logistics infrastructure, laboratory capabilities, referral networks and site readiness.

This insight helps sponsors select countries based on local intelligence and realistic delivery potential rather than assumptions.

Capability matters: Building teams that anticipate, not react

Complex regions require teams that continuously build capability by:

The result is a team equipped to anticipate issues, manage uncertainty and sustain momentum.

Best Practices for Execution

Across programs, several principles consistently distinguish successful trial delivery in SSA and MENA:

• Plan for unwritten rules. Anticipate evolving regulatory and ethics expectations.
• Focus on the true critical path. Account for ethics approvals, MTAs/DTAs and import/export processes.
• Let logistics inform strategy. Use customs, laboratory and transport realities to guide country and site selection.
• Lead with transparency. Pair realistic communication with practical mitigation strategies.
• Monitor the external environment. Track geopolitical and public health developments that may affect delivery.

Building Capability That Lasts

Well-executed studies strengthen the wider research ecosystem. Investments in investigator experience, laboratory capability, regulatory knowledge and site infrastructure contribute to a stronger research ecosystem. For sponsors, these investments create opportunities to support future hematology, rare disease and noncommunicable disease programs with less operational uncertainty and greater efficiency.

The most successful partnerships are therefore built not only to deliver today's study, but also to strengthen the foundation for tomorrow's innovation.

Leadership Perspective

"Success in Africa is not about avoiding complexity. It is about understanding it early and turning it into action. When regional expertise, local relationships and disciplined execution come together, sponsors gain the confidence to move important therapies forward and bring innovation closer to the patients who need it most."

Lynn Adams
Vice President, Internal Medicine & Dermatology, IQVIA Biotech

Final Thought

Africa’s role in sickle cell disease research extends beyond adding countries to a protocol. Success requires more than adding countries to a protocol. It requires local knowledge, regional leadership and the ability to anticipate challenges before they affect timelines.

When sponsors combine scientific ambition with the right operational expertise, complexity becomes manageable, risks become visible earlier and important therapies can move forward with greater confidence.

Learn more about how IQVIA Biotech combines global capabilities, regional expertise and biotech-focused flexibility to turn opportunity into successful clinical development.