Statistical considerations for survival analysis from medical device clinical studies.
Appropriate statistical methods are presented to estimate the 95% lower confidence limit of true event-free probability, with heavy censoring in the small sample size situation, and to compare crude probability, linearized rate, and life-table probability. The problem of survival experience extrapolation beyond the last observed follow-up is also discussed.
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Food and Drug Administration, Center for Devices and Radiological Health, Rockville, Maryland 20857, USA.
D004864:Equipment and Supplies; D006801:Humans; D015993:Life Tables; D011336:Probability; D012306:Risk; D012494:Sampling Studies; D016019:Survival Analysis