Study Leads to a New Approach for Evaluating the Effectiveness of Experimental Therapies in Clinical Trials

WASHINGTON, Nov. 5, 2017 /PRNewswire-USNewswire/ -- 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 a significant 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."

Since its inception in 2009, LFA CDAI has published important findings on the impact of background medications taken by people with lupus during clinical trials. The latest LFA CDAI analysis builds upon this work with the goal of creating smarter trial design and moving us closer to new treatments for patients now.

During the American College of Rheumatology Annual Scientific Meeting (November 3-8), the Lupus Foundation of America will conduct on-site Facebook Live interviews with lupus researchers and other health professionals about the findings from their research studies. More than 35 Lupus Foundation of America funded researchers will be presenting on findings from their lupus studies. To learn more about the Facebook Live interviews, visit http://bit.ly/ACR17hub.

About the Lupus Foundation of America's Research Program
Research is the key to solving the cruel mystery of lupus and ending its brutal impact. The Lupus Foundation of America focuses on smarter research that will lead to faster progress, and has supported more than 400 lupus research studies conducted at more than 100 medical institutions throughout the United States. Data generated by the Foundation's early research investments have provided important pathways toward identifying people at highest risk for lupus and stopping the disease before it starts. For more information on Foundation research priorities, visit lupus.org/research.

About the Lupus Foundation of America 
The Lupus Foundation of America is the only national force devoted to solving the mystery of lupus, one of the world's cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact. Through a comprehensive program of research, education, and advocacy, we lead the fight to improve the quality of life for all people affected by lupus. Learn more about the Lupus Foundation of America at lupus.org.

CONTACT:
Mike Donnelly
[email protected]
202.349.1162

SOURCE Lupus Foundation of America

Related Links

http://www.lupus.org