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Statistical Tests Based on New Composite Hypotheses in Clinical Trials Reflecting the Relative Clinical Importance of Multiple Endpoints Quantitatively
Author(s) -
Nishikawa Masako,
Tango Toshiro,
Ohtaki Megu
Publication year - 2009
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200800190
Subject(s) - statistical hypothesis testing , clinical trial , statistics , statistical analysis , alternative hypothesis , composite number , mathematics , medicine , econometrics , null hypothesis , algorithm
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.