Phase II trials

Who sets the design

Active comparator / placebo

Phases

Accelerated approval pathways
- Conditional marketing authorisation (EMA)
- Accelerated assessment (EMA)

Adaptive clinical trial designs

Smaller and more flexible clinical trials
- Phase I/II
- Phase II/III

Surrogate endpoints, biomarkers vs survival

RWE, registries

Patient involvement

Compassionate use

Documentation and submission modifications

Post market requirements