AUTHOR=Cougnaud Laure , Faes Margaux , Van Krunckelsven Dirk , De Roeck Arne , Pasetto Michela , Fieuw Ann , Andersen Claus A. , Meyvisch Paul 

TITLE=Interactive medical and safety monitoring in clinical trials with clinDataReview: a validated and open-source reporting tool

JOURNAL=Frontiers in Medicine

VOLUME=Volume 11 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1356323

DOI=10.3389/fmed.2024.1356323

ISSN=2296-858X

ABSTRACT=Continuous medical and safety monitoring of subject data during a clinical trial is a critical part of evaluating the safety of trial participants and as such is governed by protocol procedures and regulatory guidelines to meet the trial's intended objectives. We present an open-source validated graphical tool (clinDataReview R package) which provides access to the trial data with drill-down to individual patient profiles. The tool incorporates functionalities that facilitate detection of error and data inconsistencies requiring follow-up. It supports regular medical monitoring and oversight as well as safety monitoring committees with interactive tables and listings alongside graphical visualizations of the primary safety data in reports. An implementation example is given where the tool is used to deliver validated outputs following FDA/EMA guidelines. As such, this tool enables a more efficient, interactive, and reproducible review of safety data collected during an ongoing clinical trial.  data, individual or aggregate data, which poses a considerable operational challenge to the study sponsor. This challenge can be addressed in numerous ways which may or may not include outsourcing of certain activities.Traditionally, safety data can be delivered in the form of static Tables, Listings, and Figures (TLFs). While these are useful for standardized high-level safety reporting for submission to the regulatory authorities, they lack the interactivity needed to drill down into safety signals, to explore all safety readouts on a patient-level, review aggregate data, ensure signal detection or trending.