What is it about?

We present a suite of 6 interactive, open-source, web-based tools for monitoring key safety parameters in clinical trials (e.g., adverse events, lab results, vital signs results). The tools are freely available and run in your web browser without the need for any specialized or proprietary software. The tools were developed by a team of Biostatisticians and Programmers, with input and guidance from Medical Officers.

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Why is it important?

The traditional paradigm for safety reporting is to output long text-based tables of data, which make it challenging to detect meaningful signals and trends in the data. By visualizing the data with charts, we make it faster and easier for the user to detect clinically-relevant patterns and anomalies in the results. We enhance these abilities by making the charts interactive, so users can zoom, filter, sort, drill down, and navigate the data in real time. While other data visualization tools exist, many are proprietary and require purchasing expensive licenses to create and share the charts. By contrast, our tools are freely available open source, and they run in a standard web browser (e.g., Firefox, Chrome, Safari) without the need for any additional software or plug-ins.

Perspectives

It's exciting to work on novel and innovative projects like the Safety Explorer Suite. Tools like the Safety Explorer have the chance to improve the quality and efficiency of our work, by granting us greater insights into the data we collect. We work in an industry that must balance the need to work quickly (to get treatments to patients as quickly as possible) with the need to be extremely thorough and safe (to protect the health and well being of our patients). My hope is that the Safety Explorer, and other tools like it, will grant us the ability to hasten our work while also maintaining our rigorous commitment to patient health and safety.

Ryan Bailey
Rho Inc

Read the Original

This page is a summary of: The Safety Explorer Suite, Therapeutic Innovation & Regulatory Science, February 2018, SAGE Publications,
DOI: 10.1177/2168479018754846.
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