sample size adjustment

sample size adjustment

In a clinical trial, an interim assessment of blinded data to validate sample size calculations or reevaluate the sample size.
References in periodicals archive ?
Our trial for uncomplicated urinary tract infections (uUTI) just passed two-thirds enrollment, which triggers a pre-planned review of the blinded data for potential sample size adjustment. The outcome of this analysis will determine the enrollment timeline, which will guide our decision on the optimal filing strategy for the uUTI data.'
The study is expected to enroll 174 patients randomized to either EscharEx, gel vehicle placebo or non-surgical standard-of-care of either Santyl or Hydrogel, at a ratio of 1:1:1, with a 3 months follow-up and with an interim assessment for futility and sample size adjustment, once the trial has achieved approximately 50% of the target patients enrollment.
This pivotal trial will enrol 1,000 patients, with an interim look, to allow sample size adjustments, if required.