Medidata Solutions, Inc.

Glen M Devries

Edward F Ikeguchi

Alexis E Te

Edwin Goodman

Tarek A Sherif

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.

System and method for continuous data analysis of an ongoing clinical trial

The present invention is a method for conducting clinical trials. The clinical trial consists of the inventive system (); a computing device (); application database (), the personnel database (), and the trial data database; computing devices (), (), and () for use by trial participants and trial investigators; computing device (); computer devices (), (), and () for use by trial monitors; computing devices (), (), and () for use by laboratories to connect via the network ().

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New York, NY, United States of America

Glen M Devries