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The specific outcome a trial is designed to measure, fixed in advance: for example how long patients live, or how long before their cancer grows. A trial 'meets its endpoint' when the new treatment beats the comparison on that measure.
The primary endpoint determines the trial's size and its verdict; secondary endpoints (response rate, quality of life, safety, overall survival if not primary) add context but are not what the trial was powered to prove. Overall survival is the gold standard because it is unambiguous and matters most, but it takes years and is muddied when control patients later receive the new drug; progression-free survival, response rate and pathologic complete response are faster surrogates that may or may not translate into living longer. Choosing endpoints, and whether regulators should accept surrogates, is one of the most contested areas in oncology.
Shares Reading a hazard ratio, Confidence interval, Quality-adjusted survival (QALYs and Q-TWiST), Quality of life and patient-reported outcomes (QoL, PRO).
Shares Reading a hazard ratio, Confidence interval, Quality-adjusted survival (QALYs and Q-TWiST), Hazard ratio (HR).
Shares Reading a hazard ratio, Confidence interval, Randomised trial, Phase 1, 2 and 3 trials.
Shares Quality of life and patient-reported outcomes (QoL, PRO), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Progression-free survival (PFS), Overall survival (OS).
Shares P-value, Confidence interval, Primary, secondary and co-primary endpoints, Hazard ratio (HR).
Shares Primary, secondary and co-primary endpoints, Randomised trial, Phase 1, 2 and 3 trials, Progression-free survival (PFS).
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Hazard ratio (HR), Progression-free survival (PFS), Overall survival (OS).
Shares Blinded trial, Objective response rate (ORR), Progression-free survival (PFS).