Glucocorticoid Toxicity Index
Building the first FDA-compliant steroid toxicity measurement app
A first-of-its-kind Glucocorticoid Toxicity Index (GTI) tool developed at Massachusetts General Hospital was only able to be administered via pen and paper, making it difficult to use in clinical research.
Gaining a deep knowledge of the tool and the clinical trial process to transform the GTI algorithm into an FDA 23-CFR Part 11 compliant digital application.
For the first time, CROs and investigators have an intuitive digital tool to collect and measure changes in steroid toxicity over time in clinical trials, positively impacting patient health.
The pen and paper administration of a breakthrough steroid toxicity measurement tool made its use in clinical trials difficult, hampering research organizations and pharmaceutical companies.
Dr. John Stone, MD, MPH and Director, Clinical Rheumatology at Massachusetts General Hospital, and his colleague, Dr. Eli Miloslavsky, recognized a major flaw in steroid toxicity measurements in clinical trials. To address this problem, they developed the Glucocorticoid Toxicity Index (GTI), which is able to measure changes in steroid toxicity over time.
Initially, the tool was administered in clinical trials via pen and paper, but this method was inefficient and limited research capabilities. The doctors knew they needed a more scalable, researcher-friendly solution that would appeal to research organizations and pharmaceutical companies for use in clinical trials.
ADK worked closely with the doctors, gaining a deep knowledge of the algorithm and how it’s used in clinical trials in order to develop the first digital application that could accurately measure the impact of steroids in clinical trials.
While ADK strategists got up to speed on the science and how it is applied to improve patient health, ADK designers architected the interface of the application. Meanwhile, our engineers dove in to fully understand the underlying algorithm and how to embed it in the product.
The ADK team leaned on extensive experience developing software for clinical use to ensure that the tool not only provided an accurate measurement, but also an improved user experience.
In collaboration with the inventors of the tool, adjustments to the algorithm were made and a unified “language” was developed which ensured that results of the instrument matched the medical science.
After achieving critical FDA compliance, GTI is effectively measuring the impact of steroid toxicity on patient health and is enabling broader pharmaceutical research.
GTI, and a version called pGTI that’s specific to pediatrics, are allowing the clinicians behind the algorithm to provide more accurate data, and therefore treatments, to improve patients’ overall health.
We continue to support the evolution of the FDA-compliant application, and the development of trial-specific versions rolled out with various pharmaceutical partners.