Key Takeaways
- Companies will need to put more work into their clinical development strategies to succeed at the EU Health Technology Assessment Regulation’s joint clinical assessment process (JCA), a consultant says.
- Firms that are “tough on themselves” instead of being overly optimistic when it comes to health economic modelling are likely to fare best.
- Real-world evidence will not be widely included in JCAs, although data collected under compassionate use programs for certain products could be eligible for this purpose.
The EU Health Technology Assessment (HTA) Regulation will require companies to “get smart on their own clinical trial development,” according to Mark Mayhew, head of portfolio and strategy at the...
“There’s a little bit more work that needs to go into thinking through your clinical development strategy. That doesn’t necessarily have to take more time, it just takes more brains...