Showing stat.APShow all
2 papers · 1 filter
stat.AP2026
Evaluation of Individual and Trial Level Association Metrics in the Validation of a Binary Surrogate Endpoint for a True Time-to-Event Endpoint
Renee Y. Ge, Azadeh Shohoudi, Malini Iyengar +2
Candidate binary endpoints are often considered as surrogates for time-to-event (TTE) clinical endpoints, primarily because they can be assessed at earlier time points. To be submi…
stat.AP2026
Evaluation of Minimal Residual Disease as a Surrogate for Progression-Free Survival in Hematology Oncology Trials: A Meta-Analytic Review
Jane She, Xiaofei Chen, Malini Iyengar +1
Traditional health authority approval for oncology drugs is based on a clinical benefit endpoint, or a valid surrogate. In 1992 the FDA created the Accelerated Approval pathway to…