Recommendations for more efficient lupus trials
| 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.