7 ms·
Yes, it may be possible to update standard of care with a robust Phase 2 RCT that convinces doctors, especially for a pilot. Phase 3 trials for a repurposed gen
by savvak 5y ago
Yes, it may be possible to update standard of care with a robust Phase 2 RCT that convinces doctors, especially for a pilot. Phase 3 trials for a repurposed generic would be more expensive, but a new label indication would provide further incentives to update SoC because doctors and pharmacies would be less exposed to liability for prescribing off-label.