SYSTEM AND METHOD FOR CONTINUOUS DATA ANALYSIS OF ONGOING CLINICAL TRIAL

摘要

PROBLEM TO BE SOLVED: To provide a safe system where blind information is integrated so that clinical trial data and blind data are safely stored.SOLUTION: Trial data associated with a subject identifier indicating a subject is accessed from a trial database. Blind data including a subject identifier associated with a trial group identifier indicating a trial group associated with a subject identifier is accessed from a blind database. Grouped data is produced by grouping trial data into plural groups according to a trial group identifier, from the trial data and blind data, without identifying subject identifiers associated with trial group identifiers of grouped data. Statistical analysis is performed on the grouped data, and statistical significance for target parameters between plural groups in the grouped data is calculated. It is determined whether the statistical significance exceeds a predetermined threshold.