International Taskforce Proposes Structure for Improving Lupus Clinical Trials

Clinical trials are important for discovering new treatments for many diseases, including lupus. However, not all clinical trials are created in the same manner, which has led to concern about trial design with inconsistent end points in lupus study and the efficacy of new therapies. The complexity of lupus disease compounds these concerns. To address shortfalls and challenges in lupus trials, the Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE) Taskforce was created.

The TRM-SLE Taskforce is a group of lupus experts from around the world that includes academicians, clinicians, people living with lupus and patient advocacy organization representatives, industry partners, and regulatory experts. The taskforce is working together to develop a tool that determines how well treatments for lupus improve how a patient feels, functions and survives. The clinical outcome assessment (COA) tool will measure the effects of treatments in a way that is meaningful to both patients and doctors and aligns with guidances provided by regulatory agencies for approval of new lupus treatments. The LFA serves on the patient council, steering committee and scientific advisory committees of the taskforce to ensure patient preferences are prioritized throughout the duration of the project.

A new COA for the study of lupus will be a challenging undertaking, but the development of a measure that is consistent and accepted by key stakeholders will hopefully lead to successful clinical trials that advance research and bring new treatments to those living with the disease. Continue to follow the Lupus Foundation of America for updates on the development of a new COA for lupus study. Learn more about participating in clinical trials.

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