Interactive statistical monitoring to optimize review of potential clinical trial issues during study conduct.

ABSTRACT:

Background

Statistical monitoring involves the review of prospective study data collected in participating sites to detect intra/inter patients and sites inconsistencies. We report methods and results of statistical monitoring in a phase IV clinical trial.

Method

PRO-MSACTIVE is a study evaluating ocrelizumab in active relapsing multiple sclerosis (RMS) patients in France. Specific statistical methods (volcano plots, mahalanobis distance, funnel plot …) have been applied to a SDTM database to detect potential issues. R-Shiny application was developed to generate an interactive web application in order to ease site and/or patients identification during statistical data review meetings.

Results

The PRO-MSACTIVE study enrolled 422 patients in 46 centers between July 2018

SUBMITTER: Pau D 

PROVIDER: S-EPMC10064420 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature