Zhaohui Su, VP, Strategic Consulting at Veristat, shared a post on LinkedIn:
“If you haven’t read the paper by Alexandros Sagkriotis, it is highly recommended for professionals in HEOR, regulatory science, market access, or evidence and strategy.
As real-world evidence gains importance in regulatory, HTA, and payer decision making, the lack of harmonization poses a significant challenge. This paper presents practical insights from the UK, the EMA, the FDA, and global policy initiatives.
Key points include:
- The MHRA emphasizes flexibility and scientific dialogue.
- The EMA focuses on consistency and structured governance.
- The FDA offers detailed guidance that can be resource-intensive, with specific analytic expectations and thorough methodological reviews.
- HTA bodies introduce additional criteria centered on comparative effectiveness and value, contributing to fragmentation even within shared health systems.
The main takeaway is that RWE fragmentation stems from both legitimate functional differences and avoidable operational misalignment. Achieving progress will necessitate shared minimum standards and transparency mechanisms, rather than simply adding more guidance documents.”
Title: Advancing real-world evidence harmonization: lessons from the UK, EMA and global policy frameworks
Authors: Alexandros Sagkriotis
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