--- title: Steritas GTI --- ![Steritas_Website_STOX_Suite_1267x539pxl_VF1](https://www.steritas.com/hubfs/Hero-images/Steritas_Website_STOX_Suite_1267x539pxl_VF1.jpg) # The GTI ## The assessment that changed the game ### Steritas GTI ### The first validated clinical outcome assessment of steroid-toxicity The Steritas Glucocorticoid Toxicity Index (GTI) provides a systematic approach to assessing steroid-toxicity.[1] It has been validated and is FDA 21 CFR Part 11-enabled to demonstrate the steroid-sparing benefits of new drugs and treatment protocols. The GTI provides weighted outcome scores of steroid-toxicity that enable clinicians and regulators to evaluate the impact of steroid-sparing treatments. The GTI is fast, accurate and easy to implement. ### Get “steroid-toxicity reduction” in the label   Regulatory agencies such as the U.S. Food & Drug Administration and European Medicines Agency view steroid reduction as a reflection of both efficacy and safety.  The GTI, its pediatric sibling the pGTI, and the point-of-care friendly GTI-MD have been used in more than 30 disease indications, across more than 2500 sites in 92 countries. ### Evaluate the impact of steroid-sparing treatments   The GTI is  the one systematic assessment of steroid-toxicity that has been validated to inform decision making in the treatment of inflammatory diseases. The instrument provides weighted outcome scores of steroid-toxicity that enable clinicians and regulators to evaluate the impact of steroid-sparing treatments. The GTI is fast, accurate and easy to implement.   The GTI provides the only clinical outcome assessment (COA) that drug developers can rely on to demonstrate improved safety of their new treatments compared to steroids. When a new therapy is shown to be non-inferior to standard therapy with regard to efficacy, the safety of the new agent, as measured by the GTI, becomes of paramount importance.  ![](https://www.steritas.com/hs-fs/hubfs/KOL%20images%20for%20Clinician%20Quotes/Max%20Hamburger%2c%20MD_600x600pxl.png?width=480&height=480&name=Max%20Hamburger%2c%20MD_600x600pxl.png) "While some steroid-toxicities can be mitigated by tapering the drug back, a lot of the side effects are very long lasting. Steroids are like radiation, the best amount of exposure is no exposure." Max Hamburger, MD Founder, United Rheumtaology [Learn More](https://www.steritas.com/insights/in-conversation-with-max-hamburger-md?hsLang=en) ![](https://www.steritas.com/hs-fs/hubfs/KOL%20images%20for%20Clinician%20Quotes/James%20T.%20Rosenbaum%2c%20MD_600x600pxl.png?width=480&height=480&name=James%20T.%20Rosenbaum%2c%20MD_600x600pxl.png) "Steroid toxicity is rampant and it can be fatal -  bringing it onto the radar screen of the practicing physician is really, really important." James T. Rosenbaum, MD Chief of Ophthalmology emeritus at the Legacy Devers Eye Institute, Portland, Oregon [Learn More](https://www.steritas.com/insights/j-rosenbaum-on-steroid-toxicity-in-ophthalmology?hsLang=en) ![](https://www.steritas.com/hs-fs/hubfs/KOL%20images%20for%20Clinician%20Quotes/Dedee%20Murrell%2c%20MD%2c%20DSc_600x600pxl.png?width=480&height=480&name=Dedee%20Murrell%2c%20MD%2c%20DSc_600x600pxl.png) "Steroid-toxicity is a huge problem amongst our patients. When they have to be on these drugs for one or more years to keep the disease suppressed they experience many, many complicated side effects, some of which are life threatening." Dedee Murrell, MD DSc Head of the Department of Dermatology and St George Hospital, University of New South Wales, Sydney, Australia Professorial Fellow at The George Institute for Global Health [Learn More](https://www.steritas.com/insights/dedee-murrell-talks-dermatology-steroid-toxicity?hsLang=en) ![](https://www.steritas.com/hs-fs/hubfs/KOL%20images%20for%20Clinician%20Quotes/Professor%20Yoshiya%20Tanaka%2c%20MD%2c%20PhD_600x600pxl.png?width=480&height=480&name=Professor%20Yoshiya%20Tanaka%2c%20MD%2c%20PhD_600x600pxl.png) "We know that it is not easy to taper patients safely. So if we find a patient's toxicity scores are worsening we can try an immunosuppressant or a biologic drug and then we need to track to see if we can taper the glucocorticoids safely." Yoshiya Tanaka, MD PhD Professor and Chairman of the First Department of Internal Medicine, School of Medicine. Dean of Graduate School of Medical Science, University of Occupational and Environmental Health, Japan [Learn More](https://www.steritas.com/insights/prof-yoshiya-tanaka-discusses-steroid-toxicity-autoimmune-diseases?hsLang=en) ### Easy to use, whatever your workflow   The GTI balances scientific rigor and data analytics with ease of use. In most cases, the STOX® Suite calculates steroid-toxicity using data that are collected routinely in clinical trials or in practice. [Download the GTI Factsheet](https://www.steritas.com/gti-data-sheet?hsLang=en) ### STOX Suite licenses are tailored to the design of your clinical trial   We welcome your interest in the Steritas GTI and related assessments. All uses of the GTI require a license, whether you are an academic researcher, biotech start-up, a large pharmaceutical company, or a clinical research organization.   Steritas will structure a use license to support the scope and design of your trial and the needs of your organization. [![Contact Us](https://no-cache.hubspot.com/cta/default/8277484/ae0693a9-1262-44ce-b397-628a36727fba.png)](https://cta-redirect.hubspot.com/cta/redirect/8277484/ae0693a9-1262-44ce-b397-628a36727fba)  ### Discover how the GTI demonstrates efficacy and safety in your next trial [![Request today](https://no-cache.hubspot.com/cta/default/8277484/4359c404-8f3f-47df-b9db-db816887d17f.png)](https://cta-redirect.hubspot.com/cta/redirect/8277484/4359c404-8f3f-47df-b9db-db816887d17f) ### The STOX Suite in clinical trials ### Steroid-toxicity is being measured in a growing list of clinical trials for inflammatory disease drug candidates. The** **STOX Suite (GTI, pGTI and GTI-MD) has been licensed in 25+ disease indications, across 1100 sites in 80 countries across the world. [![View a list of trials](https://no-cache.hubspot.com/cta/default/8277484/3e9ed80a-a68c-4d0e-ad8c-47f3de3c3e88.png)](https://cta-redirect.hubspot.com/cta/redirect/8277484/3e9ed80a-a68c-4d0e-ad8c-47f3de3c3e88) [{"tag":"gti"}] ### Related Insights Read more Read more Read more ### References