A Lupus Foundation of America study has led to the development of a new model for assessing patient outcomes in clinical trials. The new model, based on findings from the Lupus Foundation of America's Collective Data Analysis Initiative (LFA CDAI), yields a more comprehensive profile of a lupus patient's response to therapy and takes into account the important fact that how well a patient responds to treatment varies over time. This model is an improvement over the existing standard of using a single "landmark" visit to assess outcomes. The model can also be used to design future studies and to accelerate the identification of effective new therapies that would ultimately benefit people with lupus.
The data supporting the development of this new model is part of the Lupus Foundation of America's Collective Data Analysis Initiative (LFA CDAI) study, "Estimating Duration of Response in Systemic Lupus Erythematosus (SLE) Trials," and was released at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Diego.
In a typical lupus trial, patient responses are analyzed only at their final visit (also known as a landmark visit), which doesn't account for overall effectiveness of the treatment throughout the entire study. Additionally, the new method can handle drop-outs and missed patient visits which can further complicate evaluation of a patient's response to treatment.
"As a statistician, I'm interested in exploring novel analytical methods that might help to increase the signal-to-noise ratio in SLE trials," said Dr. Mimi Kim, LFA CDAI Co-chair. "Given the variability in lupus symptoms over time, investigating the effect of treatment on response duration may be a more robust approach for identifying effective new therapies and it is critical to explore this data in order to move lupus research forward."