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January 2023

Meeting Report: The ALPHA Project — A Stakeholder Meeting on Lupus Clinical Trial Outcome Measures and the Patient Perspective

Lupus Science & Medicine

Faegre Drinker Consulting principals Lauren Bloch and Timothy Franson, M.D., coauthored an article for Lupus Science & Medicine that discusses how the lupus community may work together with regulatory agencies to simplify and standardize outcome measures to accelerate the development of lupus therapeutics.

Bloch and Franson highlight information presented during a meeting facilitated by the Addressing Lupus Pillars for Health Advancement (ALPHA) Global Advisory Committee (GAC) titled “A Stakeholder Meeting on Lupus Clinical Trial Outcome Measures and the Patient Perspective” and provide background information on the ALPHA Project, which began in 2018.

The authors outline past, present and future clinic trial outcome measure development in lupus. They also note that the GAC will share updates on progress as well as unanticipated challenges that arise throughout the process.

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