Exact(2)
No formal statistical interim analysis of the outcome data is planned.
The PI will be responsible for the correct execution and continuity of the project, online registry data base set-up and maintenance, preparation of documents (e.g. registry protocol, patient information and informed consent and data collection manual) and preparation of documents for notification to ethic committees in addition to statistical (interim) analyses.
Similar(57)
Interim statistical hypothesis tests will be performed only for the primary efficacy endpoint, LPFS.
An interim statistical analysis was performed after the first study to evaluate treatments and study design.
According to the statistical design, an interim analysis was to be conducted after enrolment of the sixtieth patient.
All authors had full access to the de-identified dataset used for analysis (including interim statistical reports and tables).
Two of these methods are sampling-based and do not require an interim statistical testing of the outcome.
A two-sided p value of less than 0.05 will be considered to indicate statistical significance (except interim analysis).
If the mean SD turns out to be higher than 5.7, we will use the statistical principles of interim analysis [ 114] to control for random errors.
The expected mean follow-up time is 3.3 years based on the enrolment of 700 patients, and 2.8 years for the enrolment of 1000 patients according to the pre-specified interim statistical analysis.
Due to the statistical characteristics of an interim analysis, the achieved power of this study would be unnecessarily reduced.
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