Sep 25, 2009

Statistical tests based on new composite hypotheses in clinical trials reflecting the relative clinical importance of multiple endpoints quantitatively

Biometrical Journal. Biometrische Zeitschrift
Masako NishikawaMegu Ohtaki

Abstract

In clinical trials, several endpoints (EPs) are often evaluated to compare treatments in some therapeutic area. Suppose that there are two EPs in a clinical trial. We propose a new set of composite hypotheses for continuous variables, taking the relative clinical importance of the EPs into account. The main hypotheses were formulated to show that a treatment is so superior to the control treatment, which is not necessarily a placebo, in one EP, that the possible non-inferiority of the treatment by at most a certain value in the other EP can be compensated sufficiently, taking the clinical point of view into account. The maximum non-inferiority margin of one EP might not be a biologically unimportant difference in exchange for much superiority of the other EP. This formulation leads to a new composite EP and a very simple test statistic. The intersection-union principle was employed to derive the proposed test.

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Citations

Mentioned in this Paper

Chronic Airflow Obstruction
Endpoint Determination
Statistical Test
Asthma
Biometry
Forced Expiratory Volume Function
Clinical Trials
Two-Parameter Models
Clinical Trial [Publication Type]

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