Operationalising Real World Evidence in Early Access Programmes: Designing Fit-for-Purpose, Low-Burden Data Collection
- Designing data collection approaches that remain within the treatment context and do not interfere with clinical trials
- Identifying what data is truly valuable to collect within EAPs vs where alternative approaches are more appropriate
- Building low-burden, scalable data capture frameworks for physicians and patients
- Translating EAP data into tangible value (e.g. informing safety, dosing, HTA, or prelaunch decision making)