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A very simple equivalence testing approach is the ‘two one-sided t-tests’ (TOST) procedure. [11] In the TOST procedure an upper (Δ U) and lower (–Δ L) equivalence bound is specified based on the smallest effect size of interest (e.g., a positive or negative difference of d = 0.3).
In null-hypothesis significance testing, the p-value [note 1] is the probability of obtaining test results at least as extreme as the result actually observed, under the assumption that the null hypothesis is correct. [2] [3] A very small p-value means that such an extreme observed outcome would be very unlikely under the null hypothesis.
The p-value is not the probability that the observed effects were produced by random chance alone. [2] The p-value is computed under the assumption that a certain model, usually the null hypothesis, is true. This means that the p-value is a statement about the relation of the data to that hypothesis. [2]
The weighted harmonic mean of p-values , …, is defined as = = = /, where , …, are weights that must sum to one, i.e. = =.Equal weights may be chosen, in which case = /.. In general, interpreting the HMP directly as a p-value is anti-conservative, meaning that the false positive rate is higher than expected.
This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products.
The interpretation of a p-value is dependent upon stopping rule and definition of multiple comparison. The former often changes during the course of a study and the latter is unavoidably ambiguous. (i.e. "p values depend on both the (data) observed and on the other possible (data) that might have been observed but weren't"). [69]
McNemar's test is a statistical test used on paired nominal data.It is applied to 2 × 2 contingency tables with a dichotomous trait, with matched pairs of subjects, to determine whether the row and column marginal frequencies are equal (that is, whether there is "marginal homogeneity").
Lack of assay sensitivity has different implications for trials intended to show a difference greater than zero between interventions (superiority trials) and trials intended to show non-inferiority. Non-inferiority trials attempt to rule out some margin of inferiority between a test and control intervention i.e. rule out that the test ...