Advancements in cardiovascular data analysis: PAROT - A novel GLP-compliant application for efficient telemetry and ECG data visualization and reporting

Abstract

Some of the challenges associated with the conduct of cardiovascular (CV) telemetry studies include the analysis, review, and management of large datasets that may be collected across different species (e.g., rat, dog, or NHP) using various study designs (e.g., cross-over or parallel). Many labs consequently face limitations such as lack of flexibility, control, and ease of GLP-compliant upgrades using either internal or off-the-shelf applications. In response to the ICH E14/S7B Q&As and best practice recommendations along with internal demand for efficient data reporting and visualization tools for CV telemetry and surface lead ECG data analysis, we have developed a novel GLP-compliant application termed Ponemah Analysis and Reporting Output Tool (PAROT). The PAROT application is a web-based platform designed to address limitations in our existing analysis tools, enhancing CV data analysis by enabling users to analyze, visualize, and generate files to allow for statistical analysis and SEND reporting. PAROT integrates with other platforms such as Ponemah for data acquisition/analysis and SAS for statistical analysis (e.g., ANOVA) and reporting. This has led to efficiency gains in data review, interpretation, reporting and informed decision making. The purpose of this abstract is to highlight the development and application of PAROT while demonstrating some of its features using real-world exemplary data that facilitate data review consistent with ICH S7B Q&As. These features include individual animal and group mean time course plots for all CV parameters, scatter plots of QT/QTc vs. HR/RR to evaluate heart rate correction methods, and statistical outputs showing least significant difference (LSD) and root mean square error (RMSE) values to demonstrate study sensitivity. Finally, the summary data can be exported to generate a file consistent with SEND. While this application is specific for internal use, it serves as a model for harmonizing data integrity, analysis, and compliance in CV studies. In summary, the PAROT application represents an enhancement in CV data review and visualization, while integrating current updates in regulatory guidance and enabling users to utilize their data effectively in drug safety and development.