In order to achieve | Recommendations | Methods |
Smaller and shorter trials | Decrease or control background medications | |
Pharmacodynamic-based selection of background medications | ||
Focus on strategical populations based on disease severity or biomarkers | ||
Use more discriminatory endpoints (especially as primary endpoints) | More stringent improvement | |
Low disease activity | ||
Sustained improvement | ||
Single organ assessments | ||
Flexibility in development programmes | Adaptive trials | |
Phase II trials could provide pivotal proof of efficacy | ||
Single organ endpoints should justify approval for all affected patients (not just people with SLE) | ||
Progress on unmet needs requiring community action | Identification and training of more trial sites | |
Outreach to more patients (especially minority patients) | ||
More work on PROs to incorporate patient perspectives in endpoints | ||
Advance precision medicine concepts for lupus |
PRO, patient-reported endpoint.