3rd IABS Workshop on Real World Evidence
Pragmatic Randomized Controlled Vaccine Trials: Toward Global Alignment on Regulatory Framework and Evidence Standards
About the workshop
Traditional randomised controlled trials (RCTs) remain the gold standard for evaluating the safety and efficacy of medicinal products, including vaccines. However, they are not always feasible, appropriate or fit-for-purpose in every setting. Timelines, ethical considerations, rare outcomes and unpredictable epidemiology can limit their applicability.
Post-authorisation observational studies can complement RCTs by providing insights into vaccine effectiveness and safety in broader real-world populations. However, their observational nature and the absence of randomisation, blinding and controlled comparisons can limit their interpretation for regulatory and policy decision-making.
Pragmatic randomised controlled trials offer an approach that combines the methodological strength of randomisation with more streamlined execution and follow-up using real-world data sources. Often embedded within routine care and conducted in broader, more representative populations, they can support more efficient evidence generation and provide further insight into vaccine effectiveness, safety and population-level impact.
Focus of the workshop
The workshop will explore the opportunities and challenges associated with pragmatic trial designs and their role within evidence frameworks and regulatory and policy decision-making.
The discussions will address:
- Scientific considerations
- Ethical considerations
- Operational considerations
- Regulatory considerations
- Real-world data sources
- Vaccine effectiveness and safety
- Population-level impact
- Global alignment and methodological standards
Building on previous IABS workshops and discussions on real-world evidence, the workshop will bring together leading vaccine experts in study design and regulatory science across relevant stakeholders. A key objective is to develop consensus-based recommendations on the conduct of vaccine pragmatic randomised controlled trials, with the aim of strengthening the evidence base and supporting regulatory and policy decision-making.
More information
Find out more about the workshop, including the programme, speakers and registration, via the official IABS event website.
Our members & strategic partners
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