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A trial can be designed to detect a tiny improvement that is statistically real but too small to matter. Protocols should state up front what size of benefit would be worth having, and be built to detect that.
Protocols pre-declare the smallest benefit patients would value, using the ESMO-MCBS or ASCO Value Framework thresholds (e.g., a hazard ratio and absolute gain in median OS or PFS), justify the sample size against it, and report whether the observed effect met it. Regulators and HTA bodies use the pre-declared threshold in review, discouraging trials sized to detect trivial differences.
Shares Nathan Cherny, Prasad: most surrogate endpoints in cancer trials correlate poorly with survival, European Society for Medical Oncology (ESMO), Progression-free survival (PFS).
Shares Prasad: most surrogate endpoints in cancer trials correlate poorly with survival, European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), Progression-free survival (PFS).
Shares European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), Progression-free survival (PFS), Overall survival (OS).
Shares European Society for Medical Oncology (ESMO), Hazard ratio (HR), Overall survival (OS), Trial design, endpoints and cost.
Shares European Society for Medical Oncology (ESMO), Hazard ratio (HR), American Society of Clinical Oncology (ASCO), Trial design, endpoints and cost.
Shares Hazard ratio (HR), Progression-free survival (PFS), Overall survival (OS).
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost.
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost.