Mike Hill
Seminars
Wednesday 30th September 2026
IPF Clinical Trials- Protecting Primary Endpoints
9:00 am
- Protecting primary endpoints is fundamentally about reducing avoidable measurement variability without influencing efficacy outcomes. In IPF, this is especially important because FVC is effort-dependent, patients are vulnerable, and lost or poor-quality assessments can be difficult to recover
- Endpoint stewardship should standardize, detect, intervene, verify, and document-while remaining blinded and proportionate. The operational principle is to improve how endpoints are measured, never what is measured; interventions should be triggered by correctable measurement-quality risks, not by whether FVC rises, falls, or suggests efficacy
- Effective stewardship combines rapid operational review with broader scientific surveillance and governance. Phase II requires fast, front-loaded review, while later-stage trials benefit from blinded RBQM/QTL/KRI monitoring, statistical and clinical adjudication, and escalation only when findings are corroborated, clinically meaningful, and operationally actionable- supporting endpoint interpretability and regulatory confidence
