JCA is underway…what it really means for rare disease evidence
Introduction This article first appeared in the Rare Focus newsletter on LinkedIn (October 2025). The EU Joint Clinical[…]
EU JCA 2025 Explained: What Rare Disease Sponsors Need to Know Now
The EU Joint Clinical Assessment (JCA) is one of the most significant changes to hit market access in years.[…]
AI, Rare Disease Research, and the Risks of “Synthetic Patients”
Artificial intelligence (AI) is beginning to find its place in rare disease research. With small populations, fragmented[…]
EU Joint Clinical Assessment: What Sponsors Need to Know in 2025
The Joint Clinical Assessment (JCA) came into force in January 2025. It begins with oncology and advanced therapies and[…]
5 Misconceptions About Patient Engagement in JCA – And Why Early Access Could Be Your Advantage
As EU HTA evolves under the Joint Clinical Assessment (JCA), the expectations for structured, regulator-ready patient engagement[…]
5 Patient Evidence Myths That Could Undermine Your EU JCA Strategy
The bar for patient evidence in EU health technology assessment (HTA) is rising fast. As the Joint Clinical[…]
Using PICO to Build Stronger Evidence in Rare Disease Advocacy
Supporting structured, independent patient input in the EU JCA era The European Joint Clinical Assessment (JCA) is[…]
How Digital Patient Insights Can Strengthen Your EU HTA Submission
The EU Joint Clinical Assessment (JCA) represents a significant shift in the regulatory landscape for companies developing[…]
Why Patient Voices Are Critical for EU Joint Clinical Assessment (JCA) Now
The European Union is in the midst of a transformative shift toward a harmonized Health Technology Assessment[…]