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.[…]
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[…]
Patient experience data is now core evidence for the Joint Clinical Assessment
The EMA’s Reflection Paper published in September 2025 confirms an important shift. Patient experience data is no[…]
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[…]
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[…]
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[…]
Understanding Rare Disease Patient Symptom Search Behaviours Online
Research into human information search behaviour offers valuable insights into how patients and caregivers navigate the process[…]
Overcoming Patient Identification Challenges in Rare Disease Research
Rare disease identification is one of the most critical challenges in healthcare. For patients experiencing vague, overlapping[…]