1 videorecording (36 min., 16 sec.) : sound, color
video file
Retrieved April 13, 2024, from https://hstalks.com/bs/554/.
Introduction -- Outline -- Clinical endpoint -- Biomarker -- Prognostic factor -- Predictive factor -- Prognostic/predictive factor -- Surrogate endpoint -- Need for surrogates -- Statistical biomarker validation -- Prognostic biomarker -- Prognostic biomarker - survival by risk group -- Predictive biomarker -- Predictive biomarker - example -- Predictive biomarker - IPASS trial -- Predictive biomarker - IPASS trial: role of EGFR -- Predictive biomarker - interaction hazard ratio -- Surrogate biomarker - single trial -- Surrogate biomarker - meta-analysis -- Validation of surrogate endpoints (1) -- Prediction of clinical outcome -- Validation of surrogate endpoints (2) -- Example in early breast cancer -- Pathological complete response -- Association between S and T -- Lack of association between treatment effects (1) -- Lack of association between treatment effects (2) -- FDA guidance for industry -- Example in gastric cancer -- DFS (PFS) and survival (OS) -- Localized gastric cancer: DFS and OS (1) -- The surrogate threshold effect (STE) -- Localized gastric cancer: DFS and OS (2) -- Localized gastric cancer: DFS and OS (3) -- Localized gastric cancer: DFS and OS (4) -- Advanced gastric cancer: PFS and OS (1) -- Advanced gastric cancer: PFS and OS (2) -- Advanced gastric cancer: PFS and OS (3) -- Messages from examples on surrogate validation -- Ideal requirements for surrogate endpoint validation