- ABOUT STERITAS
- STERITAS GTI
- CLINICAL SCIENCE
To learn more about licensing the GTI for your next trial, click on the links below:
The GTI provides the only clinical outcome assessment (COA) that drug developers can rely on to demonstrate improved safety of their new treatment compared to steroids alone. 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.
The Steritas GTI is comprised of two components: the Core Index and the Damage Checklist. The Core Index is built on nine domains that are standardized and weighted to quantify and compare indicators of toxicity that may occur over the course of a clinical trial. The Damage Checklist is an inventory of steroid toxicities that are less common yet are often severe and generally reflect permanent damage from prior steroid use. The GTI merges these two components in an intuitive workflow that aligns with the normal course of data collection in a clinic visit.
The Steritas GTI provides a nuanced view of patient results, which are summarized in the SteriTox Profile for each patient. The Cumulative Worsening Score (CWS), and the Aggregate Improvement Score (AIS), summarize all of the data entered into the GTI. Higher scores indicate higher toxicity (worsening); lower scores indicate lower toxicity (improvement). Therefore, if an investigational treatment is effective in decreasing steroid-toxicity over time, the CWS and AIS will be lower in the investigational arm of the trial.
The GTI balances rigorous data analytics with an intuitive data entry process that simplifies use for everyone that collects patient data during the course of a clinical trial.
Each patient visit can be recorded in just a few minutes. Data entry can be entered all at once or as patient data become available. Your patient’s SteriTox Profile is reported as soon as all required modules are complete.
The GTI workflow:
We welcome your interest in the Steritas GTI and pGTI. All uses of these instruments 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.
The Steritas GTI provides a definitive outcome measure for clinical investigators to compare efficacy and safety of new drug protocols to conventional steroid therapies. In recent clinical trials that resulted in FDA approval of avacopan as an add-on treatment to standard therapy including glucocorticoids for adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, glucocorticoid-induced toxic effects were secondary endpoints of the trial, as measured by both the GTI-CWS and GTI-AIS. Additional clinical trials are underway that are using the Steritas GTI to support primary and secondary safety endpoints.
1. FDA 21 CFR, Part 11 enabled tools. Software as a Medical Device (SaMD)