System and method of continuously analyzing trial data of an ongoing
clinical trial is provided. A statistical analysis is performed on a
trial database containing subject trial data without suspending the
ongoing clinical trial. If the result of the statistical analysis does
not exceed a predetermined threshold value, then the statistical analysis
is repeated while the clinical trial is ongoing. In a blinded clinical
trial, a grouped database is generated from the trial database and a
blinding database prior to performing the statistical analysis. The
grouped database groups the subject trial data according to the study
groups. The ability to continuously monitor and analyze the trial data
for statistical significance in tandem with data collection while the
trial is ongoing provides many benefits to the researchers because the
trial database no longer becomes the bottleneck in obtaining useful
results and statistical analysis can be conducted on a near real-time
basis without having to wait until completion of the trial.