Columbia University

Medidata Solutions, Inc.

Edward F Ikeguchi

Glen M Devries

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 ().

Method and apparatus of assuring informed consent while conducting secure clinical trials

This invention concerns a method of improving kidney function, whereby a negative pressure is induced in the kidney. One embodiment useful in this regard comprises a balloon catheter having at least one lumen therethrough where the proximal end of the lumen is connected to a vacuum source.

Method of inducing negative pressure in the urinary collecting system and apparatus therefor

An apparatus and method of producing a megaureter for purposes of expanding the native urothelium of the ureter to be used in various types of urinary tract reconstruction. A unique ureteral catheter which may be placed either transurethrally or percutaneously, comprising a urinary drainage tube combined with a tissue expander.

Growing community of inventors

Larchmont, NY, United States of America

Edward F Ikeguchi