Development of a Web-Based Interactive Tool for Visualizing Breast Cancer Clinical Trial Tolerability Data

Area of Science:

• Clinical trial methodology
• Data visualization
• Patient-reported outcomes

Background:

• Longitudinal patient tolerability data from clinical trials is often summarized in ways that obscure valuable insights.
• Existing methods may not fully capture the patient treatment experience.

Purpose of the Study:

• To develop an interactive web application for exploring and visualizing patient tolerability data.
• To empower clinicians and researchers with enhanced data analysis capabilities.

Main Methods:

• Utilized adverse event (AE) data and patient-reported outcomes (PROs) from the NSABP-B35 phase III clinical trial.
• Developed an interactive web application using R and Shiny, incorporating Sankey diagrams.
• Implemented four tools: AE Explorer, PRO Explorer, Cohort Explorer, and Custom Explorer for data visualization.

Main Results:

• Demonstrated the application's utility with examples from NSABP-B35 and NSABP-B30 trials.
• Users can visualize and compare AEs and PROs across treatments over specified time periods.
• The Cohort Explorer allows visualization of patient subgroups based on symptoms and severity, while the Custom Explorer supports uploading of user data.

Conclusions:

• An interactive web application has been developed for exploring and visualizing clinical trial tolerability data.
• The tool is adaptable for other clinical trial data and can enhance patient-clinician discussions on treatment decisions.