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We present data from preplanned primary and interim analyses.
An open study of olanzapine and fluoxetine for psychotic major depressive disorder: interim analyses.
Two interim analyses were performed; the second analysis resulted in early termination of the trial.
To evaluate data from a clinical trial before its completion, researchers routinely perform interim analyses.
Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection.
Interim analyses need not be equally spaced, and their number need not be specified in advance.
However, if not performed carefully, interim analyses can compromise the integrity of a clinical trial.
Interim analyses will be conducted when approximately 25%, 50%, and 75% of events have occurred.
Group sequential tests are widely used for interim analyses in randomized clinical trials.
Interim analyses (multiple stages) are usually built-in to terminate futile treatments.
However, as interim analyses revealed a lower than 0.59 correlation in our study sample.
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