Discover how global sponsors and CROs can optimize clinical trial outsourcing and patient engagement in Africa by addressing cultural, operational, and regulatory complexities from day one.
Guest
- Dr. Sam Mbunya
- Global Patient Advocate; Consultant in Patient Education, Advocacy & Program Management
- Focus: Sickle cell disease, hemophilia, rare blood disorders, and cancer in African regions
- Based in Malmö, Sweden; Active in global project collaborations (US, Kenya, African universities)
Episode Overview
This session, recorded live at COG Nordics, features a practical fireside chat with Dr. Sam Mbunya—an experienced patient advocate and program consultant—exploring the real-world nuances of launching and sustaining clinical trial operations in Africa. The discussion moves beyond broad generalizations, highlighting how local context, community trust, and operational diligence are critical in clinical trial outsourcing and CRO selection for African sites.
Key topics include the operational and cultural barriers sponsors often overlook, such as health literacy, transport, family decision dynamics, and the legacy of previous studies. Dr. Mbunya outlines best practices for early and ongoing engagement with patient groups, community leaders, and local health systems, emphasizing why these steps are essential for both participant protection and long-term study viability.
Listeners working in clinical operations, clinical trial outsourcing, and CRO/vendor management will find actionable strategies for designing studies that respect local realities. The conversation also explores how partnerships, clear communication, and data stewardship can help sponsors and CROs avoid common pitfalls and deliver on inclusion goals—turning compliance into true community impact and clinical study optimization.
Key Moments
00:00:20 – Why Africa is not a single trial environment and the operational impact of country and community diversity
00:02:53 – The health literacy gap: How poor understanding of diseases and research affects trial recruitment and retention
00:04:21 – Patient “hope” vs. informed participation: Why transparent communication matters in clinical trial outsourcing settings
00:06:03 – Addressing practical barriers such as transport, family dynamics, and cultural decision-making during CRO selection and protocol development
00:08:02 – The pitfalls of a “one size fits all” approach: Communicating and customizing study materials for multilingual, multicultural settings
00:10:09 – The importance of engagement after negative outcomes: Building trust and credibility post-trial, not just during recruitment
00:12:44 – Distinguishing participants from implementers: How involving patients from the outset improves both feasibility and ethical compliance
00:16:25 – Regulatory maturity and bottlenecks: Strategies to work with local and national ethics boards for timeline and approval optimization
00:18:09 – Leveraging technology and patient advocates for scalable education and improved health literacy
00:20:02 – The role of roundtables, advisory councils, and WhatsApp groups in ongoing community dialogue and study support
00:26:04 – Top three challenges for sponsors: Open-minded protocol design, governmental engagement, and robust data stewardship
Top 3 Takeaways
- Prioritize Early Engagement with Local Stakeholders - Integrate patient groups, community leaders, and local systems into study design and CRO selection processes well before recruitment begins to ensure buy-in, accurate feasibility, and operational alignment.
- Invest in Health Literacy and Culturally Relevant Communication - Optimize study materials and participant discussions for language, tradition, and educational context—driving true understanding, reducing risk, and strengthening clinical operations best practices.
- Treat Regulatory and Data Strategies as Core Pillars, Not Afterthoughts - Engage proactively with national authorities and invest in transparent, locally tailored data management to streamline approvals, foster trust, and enable long-term clinical study optimization at new sites.
Links & Resources
Quotes
“Have an open-minded approach where you look at how people live, listen to their challenges, and engage government and patient advocacy groups from the protocol stage, not after.” – Dr. Sam Mbunya
“It’s not just about recruiting fast—it’s about protecting participants, building trust, and ensuring the process starts with patients and families, not just ends with them.” – Dr. Sam Mbunya
“Data protection and ownership are critical—robust registries and transparent practices help optimize clinical trial outsourcing and build credibility.”
“There’s always this backdrop that the global north puts Africa as a one size fits all project; but the dynamics, language, and context require a fundamentally different operational approach.”
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