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SUPERIORITY TEST FOR PROPORTIONAL ODDS SURVIVAL MODELS WITH CURE FRACTION
Studies that prove the superiority of a drug in relation to others already existing in the market are of great interest in clinical practice. Based on them the Brazilian National Agency of Sanitary Surveillance (ANVISA) grants superiority drugs registers which can cure faster or increase the probability of cure of patients, compared to standard treatment. It is of the utmost importance that hypothesis tests control the probability of type I error, that is, they control the probability that a non-superior treatment is approved for use; and also achieve the test power regulated with as few individuals as possible. Tests of hypotheses existing for this purpose or disregard the time until the event of interest occurrence (allergic reaction, positive effect, etc.) or are based on the proportional hazards model and ignore the possibility of cure. In this work we developed and investigated a hypothesis tests for clinical trials of superiority, based on the comparison of survival curves under the assumption that the data follow the proportional survival odds model considering cure fraction. Simulation studies are conducted to analyse the ability to control the probability of type I error and the value of the power of the tests when the data do not satisfy the assumption of the test and when they satisfy, for different sample sizes. We conclude that the probability of type I error is underestimated when the data do not satisfy the assumption of the test. And it is controlled when they satisfy, as expected.
Superiority test, type I error, cure fraction
Juliana Cobre, Juliana Cecília da Silva Teixeira