In a new report published by Buie et al in Lupus Science & Medicine, the Addressing Lupus Pillars for Health Advancement Project Global Advisory Committee—comprising physicians, biotechnicians, patient advocates, and government consultants—outlined new methods for improving lupus clinical trial outcome measures, according to the Lupus Foundation of America. The report comes after experts recognized the need for more efficient standards of drug development in order to more effectively treat patients with lupus. The committee suggested several modifications to the current procedures—such as simplified evaluation tactics to aid researchers in capturing lupus disease activity across all patient groups; the sharing of data sets from all clinical trials, even those that did not reach their endpoints; the inclusion of patient perspectives on clinical trial outcomes to inform a more patient-focused approach; and strategies for seeking approval from drug regulation organizations. They also addressed the hurdles that researchers currently hope to overcome regarding the development of novel lupus therapeutics—including outcome measure and symptom-targeting variability caused by the disease’s intricacy, which can result in the involvement of multiple U.S. Food and Drug Administration review divisions and complicate the creation of comprehensive tools to analyze outcome measures. “Consensus across the lupus community to simplify and standardize clinical trial outcome measures would provide a more promising avenue for evaluating the success of interventions … [and lead to] approval of more powerful tools that will help the future of lupus drug development,” concluded Karen H. Costenbader, MD, MPH, Director of the Lupus Program at Brigham and Women’s Hospital and Chair of the Medical-Scientific Advisory Council at the Lupus Foundation of America.
May 25, 2023