Mastering Hierarchical Composite Endpoints: Challenges & Opportunities in CKD Trials
Time: 1:30 pm
day: Pre-Conference Workshop C
Details:
Hierarchical composite endpoints (HCEs) combine multiple clinical and surrogate endpoints in a single trial, providing a pathway to demonstrate efficacy across various outcomes in CKD trials. However, the complexity of developing, ranking, and interpreting HCEs presents unique challenges, especially in CKD trials where surrogate endpoints such as proteinuria or GFR slope play a critical role.
This workshop will provide an in-depth exploration of how to effectively design, analyze, and interpret HCEs in CKD, addressing both statistical and clinical concerns.
This workshop will cover:
- Understand the differences between HCEs and traditional composite endpoints and their application in CKD trials to gain a thorough understanding of HCEs and their role in CKD trials.
- Learn to rank endpoints by clinical significance, from mortality to surrogate markers like GFR slope, while considering their impact on patient outcomes to develop strategies for constructing HCEs that accurately reflect clinical outcomes and surrogate markers.
- Dive into the complexities of interpreting a statistically significant win ratio HCEs, and examine the clinical meaning behind ratios of 1.1, 1.2, or higher and address criticisms of surrogate endpoint dominance.
- Explore strategies to integrate surrogate endpoints without overshadowing clinically meaningful outcomes, avoiding pitfalls of less impactful markers to understand how to balance surrogate endpoints with clinical significance.