Case Study: Scientific Advice/Early Model

Situation

The partner needed support in ensuring its phase 3 trial design was set up for a potentially successful regulatory assessment and HTA in the UK and the EU

Objective

Seek scientific advice on the phase 3 trial design and early economic model from NICE and EMA

Solution

Submit scientific advice briefing book focusing on trial design and economic model design and outcomes in consultation with clinical/HEOR experts on key outcomes and model design

Impact

Scientific advice received was useful in reinstating robustness of Phase 3 trial program and redesigning the core economic model to suit HTA needs