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Engineering an FDA-compliant digital instrument

Taking the leading steroid toxicity index digital with MGH

Technology Architecture
UX / UI Design
Product Strategy
React Native

The Challenge 

As leaders in their field, Dr. John Stone, MD, MPH and Director, Clinical Rheumatology at Massachusetts General Hospital and his colleague Dr. Eli Miloslavsky understood the critical role that glucocorticoids (commonly known as steroids) play in medicine. Steroids are used to treat a wide array of autoimmune diseases (such as multiple sclerosis and rheumatoid arthritis), allergies, skin conditions, and more. However, in their highly respected clinic at MGH, they often found themselves managing the negative side effects of steroids for their patients.

Drs. Stone and Miloslavsky recognized a major flaw in existing measurements of steroid toxicity in clinical trials. These instruments only measured the benefits of steroids, while ignoring the side effects. Unfortunately the side effects of steroids can be quite severe, including higher cholesterol and triglycerides, greater vulnerability to infections, and a higher risk of diabetes. Longer-term, steroids can cause weight gain, slower healing, fatigue, and depression, to name just a few.

Seeing this problem, they began to develop the Glucocorticoid Toxicity Index (GTI), a novel balanced outcome measure that scored change in steroid toxicity over time. The research behind the GTI was developed by 20 international clinicians across a variety of sub-specialties, and has been published and peer reviewed.

While the science of the GTI was very well received, adoption in clinical trials was limited by the difficulty of using the index. The tool was administered via pen and paper, which caused many administrative challenges in the research setting. Recognizing the need for a digital solution that appealed to research organizations and pharmaceutical companies, Drs. Stone and Miloslavsky approached ADK with their vision and initial funding from a pharmaceutical partner.

The Solution

ADK and Drs. Stone and Miloslavsky began by working together to develop a deep, shared understanding of the algorithm and the use case during clinical trials. ADK’s designers architected the interface of the application, while engineers dove in deep to understand and document the algorithm’s intent. ADK’s experience developing applications for clinical environments ensured that the application and the algorithm were documented and thoroughly defined. In collaboration, adjustments to the algorithm were made and a unified “language” was developed which ensured that results of the instrument matched the medical science.

The result is the Glucocorticoid Toxicity Index (GTI), a first-of-its-kind software which offers clinical researchers an intuitive interface to collect and measure steroid impacts in clinical trials

After the successful launch of GTI’s .Net and React application, ADK’s product team attended an international conference on pediatric rheumatology with the goal of developing an algorithm for a pediatric-specific GTI. Due to the differences in medical protocols and care standards for pediatric patients, the algorithm and interface were adjusted. 

Both GTI and pGTI are now live and in use by clinical research organizations (CROs) to measure how steroid toxicity is impacting patient health. The GTI application is now FDA 21 CFR Part 11 compliant, which will enable much broader pharmaceutical research applications going forward. 

Why ADK?

The clinicians behind GTI had the vision to see that existing methods for measuring steroid toxicity were failing patients. And they had the clinical expertise to develop their own algorithm. They knew that using this more accurate data, medical staff could provide more effective treatments for patients and reduce the risk of endangering patients’ overall health. They just needed a team to help them translate their clinical vision into robust, FDA-compliant software.

Because of our deep experience in clinical environments and building to digital healthcare standards, we were able to translate the medical science behind GTI into a robust, FDA-compliant application with Dr. Stone and his team. We continue to support them as they enhance the product and roll-out trial-specific versions with various pharmaceutical partners.