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


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.

  • References17
  • Citations2


Mentioned in this Paper

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

Related Feeds


This feed focuses in Asthma in which your airways narrow and swell. This can make breathing difficult and trigger coughing, wheezing and shortness of breath.

Allergy and Asthma

Allergy and asthma are inflammatory disorders that are triggered by the activation of an allergen-specific regulatory t cell. These t cells become activated when allergens are recognized by allergen-presenting cells. Here is the latest research on allergy and asthma.

Related Papers

Bulletin of the NYU Hospital for Joint Diseases
Emmanuel Lesaffre
© 2020 Meta ULC. All rights reserved