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Two trials reported changes to the primary endpoint based on interim analysis [ 9, 15], one introduced an additional (secondary) endpoint [ 22] and one dropped an endpoint [ 23] subsequent to interim analyses.
We recently proposed a 2-stage phase II design that has the option for direct assignment (i.e., stop randomization and assign all patients to the experimental arm in stage 2) based on interim analysis (IA) results.
Recommendations made by the DMC or based on interim analysis were identified and potential sources of bias assessed.
The majority of recommendations based on interim analysis or by DMCs were either to continue the trial as planned or to terminate early.
A search strategy that allowed for the identification of relevant case studies with extended recommendations based on interim analysis or by DMC was used.
The TLR rates for Zilver PTX in each of the matching registry subpopulations, based on interim analysis, were 6%% at 12 months [ 14].
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It has been calculated that 700 patients are required to identify risk predictors of the primary endpoint, with a possible increase to 1000 patients based on interim risk analysis.
No treatment change was made based on interim PET scan results.
It should be noted that if there appears to be an unexpectedly high number of repair breakdowns among short-term catheterization cases compared to long-term catheterization cases either as reported by study site staff or the study monitor, or based on the interim analysis, any one of the study Institutional Review Boards (IRBs) may also temporarily or permanently halt the study at any time.
"This is about what was expected based on the interim analysis," he says.
This report includes patients who participated for ≥6 months based on an interim analysis date of February 12 , 2015
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