Innovating Endpoints in IPF: Including & Beyond FVC to Determine Clinical Efficacy

FVC remains the gold-standard endpoint for IPF clinical trials, but its variability can undermine trial reliability, increase costs, and complicate regulatory approval. As the field moves forward, there is growing recognition of the need to refine endpoints by integrating additional, more predictive measures. This interactive workshop will spotlight innovative strategies for endpoint selection— drawing lessons from other respiratory diseases and leveraging data-driven approaches to boost trial sensitivity and efficiency.

Key discussion points:

Addressing the Limitations of FVC

  • Exploring the variability of FVC and its implications for trial design
  • Identifying complementary or alternative measures to improve accuracy and enhance trial success Learning from Composite Endpoints in Pulmonary Arterial Hypertension
  • Assessing how composite endpoints—such as six-minute walk distance, respiratory hospitalizations, and imaging biomarkers—can provide a more holistic measure of efficacy Advancing Clinical Trial Desig
  • Harnessing quantitative, data-driven approaches to develop novel composite endpoints that increase sensitivity, facilitate regulatory approval, and reshape the future of IPF clinical research