A review of EMA approvals, clinical guidelines, Health Technology Assessment (HTA) decisions, and real-world treatment patterns will identify the evidence needed to inform the PICO requirements for each country.
The Joint Clinical Assessment (JCA) consolidation maps distinct and overlapping EU Member State requirements into the fewest possible PICOs to address all Member State needs.
The consolidated PICO scope is validated by key opinion leaders from EU member states, to ensure all relevant comparators and subpopulations are captured and that PICOs are reflective of real-world clinical practice.