Exact(2)
Lack of a priori definition of the primary endpoint (to be tested in a confirmatory manner) and lack of an unambiguous delimitation for the secondary endpoints (to be analysed descriptively/exploratively).
Despite the overall improved study quality, again, various methodological weak points were notable in the analysed studies, including: Lack of a priori definition of the primary endpoint (to be tested in a confirmatory manner) and lack of an unambiguous delimitation for the secondary endpoints (to be analysed descriptively/exploratively).
Similar(58)
The family-wise error rate (FWER) control is highly critical for clinical trials with multiple endpoints to be tested.
These composite endpoints need to be tested in future studies to confirm their utility.
32 That is, after success of the noninferiority test for CV safety by ruling out an RR >1.3, CV superiority and specified secondary endpoints were to be tested based on a predefined sequence.
With regard to survival time, the regulatory agencies will demand OS as a primary endpoint if the substance to be tested is probably more toxic than the comparator, if no accepted therapies are available for further treatment and if the time from disease progression to death is short.
Such preclinical data must then help drive the appropriate early phase I combination studies to be evaluated - studies which if well tolerated and active, as determined by relevant pharmacodynamic endpoints, need to rapidly be tested in phase II studies utilising enrichment strategies to select for the most appropriate breast cancer phenotypes.
The superiority of empagliflozin compared to glimepiride on the primary endpoint will be tested after 104 weeks' treatment.
Differences between the four study arms in the two primary endpoints will be tested according to the intention-to-treat philosophy.
The 2.5% significance value is chosen to adjust for the multiple comparisons, because the primary endpoint will be tested on the patient and partner separately.
Only the primary endpoint will be tested in a confirmatory way.
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