TRACE Project (2025–2026)
The TRACE Project (Trial Regulation and Clinical Ethics Optimization) is a regional initiative launched in 2024 to harmonize and strengthen clinical trial regulatory frameworks and ethics review processes across specific African nations, aiming to create a coordinated, transparent, and efficient clinical trial environment.
This optimization is driven by four workstreams, including Capacity Building & Accreditation, which professionalizes ethics committees, and Digital Transformation, which focuses on digitalization tools and piloting an AI-based consent reviewer to improve transparency and efficiency. Ultimately, TRACE seeks to address systemic bottlenecks and optimize trial review systems by launching IRB certification toolkits and working toward a proposed Key Performance Indicator of a 30% reduction in review timelines