SPEAC’s mission has always centered on strengthening the foundations of vaccine safety—through tools, guidance, and evidence, in support of the people who make real-time safety decisions. This month, we’re continuing that work by delivering our largest Data and Safety Monitoring Board (DSMB) training yet, with four separate cohorts and nearly 40 participants engaged across multiple live training sessions.
The program began in October 2025 and is now mid-session, bringing together clinicians, epidemiologists, statisticians, pharmacovigilance specialists, and public health professionals from a wide range of regions in Africa. The growing emphasis on African participation reflects both an increased demand for high-quality safety oversight and the region’s central role in trials for priority pathogens such as Lassa fever, Rift Valley fever (RVF), Mpox, and Marburg virus—all of which require strong, harmonized safety review frameworks to support ongoing and future studies.
A key feature of this year’s training is its close collaboration with Africa CDC, which plays a central role in shaping regional public health priorities and strengthening vaccine safety systems across the continent. This partnership ensures that DSMB content aligns with regional priorities, strengthens continent-wide safety surveillance capacity, and supports Africa’s long-term readiness for trials involving high-consequence pathogens.
A Multi-Session Curriculum Designed for Real-World Decision-Making
SPEAC’s DSMB training is built around the practical realities DSMB members face when reviewing emerging data and guiding safety decisions. Rather than focusing solely on theory, the curriculum emphasizes applied, scenario-based learning, including:
- Structured approaches to safety data review
- Recognizing and interpreting potential safety signals
- Discussion of serious adverse events and adverse events of special interest (AESIs) using standardized frameworks
- Use of SPEAC summary tables, templates, and definitions to support consistent judgment
- Board communication pathways and documentation best practices
Each cohort progresses through the same core curriculum, enabling participants from different regions and backgrounds to develop a shared foundation in high-quality, evidence-informed safety oversight.This year’s program also integrates regional perspectives provided through Africa CDC, ensuring that the training reflects the safety challenges, regulatory contexts, and outbreak response priorities most relevant to the African continent. This alignment helps equip participants with decision-making approaches tailored to real-world conditions in low-resource and epidemic-prone settings.
Why DSMB Training Matters for Global Preparedness
DSMBs play a central role in ensuring the ethical and scientific integrity of clinical research—especially in areas where pathogens are evolving, evidence is limited, or rapid response is required.
Yet around the world, DSMB members often face similar challenges:
- Variation in how adverse events are defined and interpreted
- Limited access to standardized tools
- Differences in decision-making frameworks
- High-pressure contexts with evolving data and incomplete information
SPEAC’s training aims to help bridge these gaps by providing consistent, tools-based guidance that DSMB members can use regardless of setting, region, or disease focus. In Africa—where trials for Lassa fever, RVF, Mpox, and Marburg often operate across multiple countries and partners—strengthening DSMB skills contributes directly to both regional and global preparedness.
A Growing Community of Practice
With two sessions (four cohorts total) running in parallel, this year’s program has created one of the largest cross-cohort DSMB learning environments SPEAC has ever facilitated. Participants engage not only with SPEAC faculty, but also with one another—sharing experiences, evaluating case examples, and discussing how standardized approaches can be adapted for the settings in which they work.
This collaborative environment has been especially valuable for participants who are new to DSMBs, those who are joining boards for the first time, and those who serve on multiple studies and benefit from greater consistency across roles.
What Comes Next
The training will continue over the next several weeks, with upcoming modules focusing on:
- Data interpretation challenges
- Consensus-building and board dynamics
- Communicating decisions to sponsors
- Ethical considerations in safety oversight
- Final applied case discussions using standardized templates
As with past sessions, SPEAC will refine future offerings based on participant feedback and evolving needs across the global vaccine safety community, including continued collaboration with Africa CDC as part of broader efforts to strengthen safety systems across the continent.
Learn More About DSMB Support
SPEAC provides a suite of tools, templates, and resources to support DSMBs, developers, and researchers working in safety assessment. These include guidance on AESIs, standardized decision-making tools, and additional training materials.
Explore SPEAC’s DSMB support, tools, and resources:
https://speacsafety.net/dsmb-support/
