Client team was preparing to move a new candidate vaccine into global Phase III trials. The global and local medical affairs and HEOR organizations needed to understand what evidence is required to support vaccine technical committee approvals and what country-specific data gaps exist.
- Multidisciplinary framework:
– Identified the clinical, economic, and humanistic outcomes data critical for vaccine technical committees to recommend a vaccine for use
– Conducted multidisciplinary workshop to identify data requirements across the organization.
- Assess data gaps:
Conducted a systematic literature review across 12 developed and developing countries that resulted in evaluating the quality and utility of ~300 articles.
We identified country-specific data gaps and developed evidence generation strategies that enabled country leads to prioritize local evidence generation prior to vaccine approval meetings.