Increasingly, medical affairs teams are being called upon to play more expansive roles that may include analyzing health economics, informing product development and commercialization strategies, and driving innovative evidence generation in clinical development and postmarket surveillance activities.
Clinical outcome assessments (COA) to quantify steroid-toxicity can help medical affairs teams identify and communicate important patterns and trends in patient demographics, inform risk assessment and patient stratification efforts, improve safety monitoring, support regulatory compliance, and much more.
With the right tools to analyze steroid-toxicity in large patient cohorts and existing population data, medical affairs and health economics and outcomes research (HEOR) teams can generate the evidence needed to support crucial decisions and drive improved steroid use in clinical practice.
The STOX® Suite is a selection of clinical outcome assessments (COAs) designed to score and quantify changes in steroid-toxicity over time. The scientifically rigorous algorithms at the heart of the STOX Suite provide unprecedented power to measure steroid-toxicity in prospective and retrospective studies of large patient populations and existing data, including insurance claims and electronic health records (EHRs).
The STOX Suite includes clinical outcome assessments (COA) optimized for different settings:
The STOX Suite has been licensed in 25+ disease indications, across 1100 sites in 80 countries across the world.
With its streamlined domains based on data routinely collected in the clinic and recorded in EHRs, the GTI-MD is ideally suited for retrospective studies. Using existing data, researchers can derive glucocorticoid-toxicity scores across large patient cohorts to investigate relationships between glucocorticoid use, cumulative dose and increased steroid-toxicity. This provides a foundation for assessing the benefits of non-steroid alternative treatments.
Through quantitative analysis of treatment costs associated with the 80+ known steroid-toxicities, researchers will be able to develop a more accurate picture of how glucocorticoids affect patients outside of controlled clinical trials and anecdotal data collected at the point of care. Ultimately, insights gained using the GTI-MD may inform treatment guidelines, payer coverage, and decisions about where to focus development efforts to serve the greatest medical need.
Martha N. Stone