Bringing new therapies to market requires more than strong clinical data, it requires alignment with diverse health technology assessment (HTA) requirements across regions. Differences between HTA bodies like NICE (UK), G‑BA/IQWiG (Germany), and HAS (France) can significantly impact global market access strategy and clinical development planning.
In this conference poster, Daria Shamaida, Senior Statistician II, explores how variation in HTA submissions, including evidence requirements, documentation and timing, creates complexity for multi-country drug development.
From comparator selection to sensitivity analysis, subgroup evaluation, and missing data handling, the same clinical dataset often needs to be adapted to meet different expectations.
By applying strong biostatistics and biometrics expertise, this work highlights how to:
- Align clinical trial design with global HTA expectations
- Optimize health economics and outcomes research (HEOR) strategies
- Strengthen evidence generation for market access
- Manage uncertainty across cost-effectiveness and clinical outcomes
With the right biometrics CRO expertise and early statistical planning, organizations can navigate HTA complexity with confidence, ensuring evidence packages ready for global submission. Click on the poster below to learn more.
