Optimizing Recruitment and Biomarker Precision in Autoimmune and Rare Autoimmune Trials

Autoimmune and rare autoimmune diseases are complex and pose challenges for clinical trials. These conditions vary widely in their manifestations and severity, making them difficult to diagnose and treat. Inherent heterogeneity also presents unique difficulties in protocol development, such as developing entry criteria and complex endpoints, recruitment, and retention. While patients often experience a diagnostic odyssey, which causes enormous stress and frustration, new advancements in precision medicine and biomarker-informed decisions are changing our approach.