A Dialogue on How to Spark Clinical Trial and Policy Engagement in Africa
Date: November 13, 2024

Overview:
The webinar convened a diverse group of stakeholders, including patient advocacy leaders, medical professionals, researchers, and policymakers, to explore clinical trial engagement and related policy issues in Africa. The discussion highlighted existing challenges, untapped opportunities, and strategic approaches to advancing clinical trial capabilities on the continent.

Opening Presentation:
Dr. Dan Milner, Executive Director of the ATOM Coalition, delivered the keynote presentation. Drawing from his extensive global health background, Dr. Milner detailed the profound importance of clinical trials in Africa, emphasizing their role in advancing medical knowledge, enhancing patient care, and ensuring sustainable access to medications. His on-the-ground experience in Africa and Haiti has cemented his status as a pivotal figure in tackling healthcare disparities.

Key Points from Dr. Milner’s Presentation:

1. Broader Impact of Clinical Trials:
o Contribute to economic growth within healthcare systems and reduce patient financial strain.
o Enhance training, education, and technology transfer for medical professionals.
o Provide critical data that informs health policies and regulatory frameworks.
o Facilitate market readiness for future medication availability.

2. Challenges Hindering African Clinical Trial Participation:
o Limited infrastructure, trained personnel, and trial facilities.
o Ethical concerns about trial necessity and justification.
o Predominant focus on infectious diseases, with insufficient emphasis on oncology.
o Underrecognition of Africa as a viable market for cancer research.

3. Benefits of Expanding Clinical Trials in Africa:
o Direct patient care and support during trials.
o Improved medical knowledge and professional competency.
o Creation of valuable data for policymakers, leading to informed decisions.
o Market insights that pave the way for partnerships and sustainable access.
o Most crucially, ongoing access to medications after trial completion.

Current Status of Clinical Trials: Dr. Milner shared data from the U.S. registry to illustrate trial activity disparities:
• Ghana: 253 trials, 4% focusing on cancer.
• Kenya: 772 trials, 6% focusing on cancer.
• Malawi: 350 trials, 5% focusing on cancer.
• U.S. states like Alabama and Massachusetts were noted for significantly higher trial numbers, underscoring the disparity.

Panel Discussion Insights:
Following Dr. Milner’s presentation, a panel of experts provided additional perspectives:
• Nestor Masaru, an oncologist from Uganda, stressed the importance of raising awareness at both ministerial and community levels to promote clinical trial engagement.
• Penny, a patient advocate, highlighted the need for integrating patient voices throughout the trial process to ensure informed consent and a patient-centered approach.
• Flavia, an experienced clinical trial expert, pointed out that inadequate consent processes and socio-cultural dynamics often lead to high dropout rates.
• Natayna, pharma representative highlighted Africa’s success in managing infectious diseases and proposed applying these lessons to cancer care. She stressed prioritizing cancer treatment and research through clinician training, partnerships, and ministry support. Key strategies included culturally aware outreach, early screening programs, and using cancer centers as models. Natayna also urged demonstration projects to build sustainable partnerships among NGOs, governments, and communities, advancing clinical trials in Africa.

Recommendations for Advancement:
1. Multi-Sectoral Partnerships: Strengthen collaborations among governments, NGOs, and academic institutions to build and sustain clinical trial infrastructure.
2. Community Engagement: Implement comprehensive patient education and create community advisory boards to boost participation and retention.
3. Centers of Excellence: Develop centralized clinical trial hubs to enhance accessibility, capacity-building, and professional training.

Key Takeaways:
• Building clinical trial capacity in Africa requires holistic strategies involving policy backing, educational outreach, and partnerships with local and global stakeholders.
• Ensuring drug availability post-trial and continued patient support are vital for leveraging trial benefits.
• Addressing high dropout rates involves refining informed consent processes and reducing logistical barriers for participants.
Concluding Remarks: Dr. Milner concluded by highlighting the ethical imperative of ensuring that clinical trial outcomes translate into real-world benefits for African communities. The panelists collectively advocated for sustained dialogue, ongoing education, and collaborative efforts to advance the clinical trial landscape in Africa.

Acknowledgments:
Andrew Spiegel, Chair of the World Patients Alliance, extends heartfelt gratitude to all panelists and participants for their valuable contributions. Special thanks to Bristol Myers Squibb for their generous sponsorship and unwavering support, which made this impactful webinar possible.