- ABOUT STERITAS
- STERITAS GTI
- CLINICAL SCIENCE
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 summarizes results in a SteriTox Profile for each patient. The Cumulative Worsening Score (CWS), and the Aggregate Improvement Score (AIS), provide nuanced interpretations of steroid-toxicity from the same dataset. Higher scores indicate higher toxicity (worsening), lower scores indicate lower toxicity (improvement). Therefore, if an investigational treatment is effective in decreasing steroid-toxicity, the CWS and AIS will be lower in the investigational arm of the trial.
1. Fardet L, Petersen I, Nazareth I. Prevalence of long-term oral glucocorticoid prescriptions in the UK over the past 20 years. Rheumatol Oxf Engl. 2011;50:1982–1990.
2. Laurence Fardet, MD, PhD, Irene Petersen, PhD, and Irwin Nazareth, MD, PhD Monitoring of Patients on Long-Term Glucocorticoid Therapy- A Population-Based Cohort Study. Medicine. Volume 94, Number 15, April 2015
3. Rice JB, White AG, Johnson M, Wagh A, Qin Y, Bartels-Peculis L, Ciepielewska G, Nelson WW. Healthcare resource use and cost associated with varying dosages of extended corticosteroid exposure in a US population. J Med Econ. 2018 Sep;21(9):846-852. 10.1080/13696998.2018.1474750. Epub 2018 May 23. PMID: 29741439.
4. FDA 21 CFR, Part 11 enabled tools. Software as a Medical Device (SaMD)