Michelle Richardson
Associate Director, Patient-Centered Research & Clinical Outcome Assessment Otsuka
Seminars
Thursday 16th October 2025
Shaping the Future of CKD & ADPKD Trials with Meaningful Patient-Reported Outcomes (PROs)
9:00 am
- Ensuring PROs capture what matters to the ADPKD patient population (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
- Harmonizing clinician-designed PRO measures with what regulators (e.g., FDA/EMA) expect to ensure trial endpoints are accepted
- Leveraging real-world evidence and external controls to validate PRO metrics, reduce placebo arms, and speed regulatory approval
Tuesday 17th March 2026
Moderator:
