Shaping the Future of CKD Trials with Meaningful Patient-Reported Outcomes
- Harmonizing clinician-designed PRO measures with what regulators (e.g., FDA/EMA) expect to ensure trial endpoints are accepted
- Ensuring PROs capture what matters to patients (symptoms, QoL, treatment burden) especially in early or mild CKD, not just lab or imaging changes
- Integrating PROs early in development (Phase II/POC) to inform Phase III design and labelling claims
- Leveraging real-world evidence and external controls to validate PRO metrics, reduce placebo arms, and speed regulatory approval