FDA and Lupus Research Alliance Form Drug Development Consortium
The FDA is teaming up with the Lupus Research Alliance to launch the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to address challenges affecting clinical trial success.
The consortium will consult with lupus patients, medical societies, industry, academic clinical researchers and scientists, as well as the FDA and other federal agencies to “define common challenges in drug development and facilitate approaches that will have the most immediate impact on advancing therapeutic development” for the disease.
The FDA says the forum will consider the impact of potential treatments by “refining existing measurement tools that clinical research has shown may not always adequately assess a drug’s effectiveness” and seek to optimize patient-reported outcome measures.
About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latinx, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
