Phase III Clinical Trial
Large-scale (1,000-5,000+ patients) randomized controlled trials confirming efficacy and monitoring adverse reactions. Pivotal for regulatory submission. Often multicenter, international, and double-blind.
Contoh
- Superiority vs non-inferiority
- Intent-to-treat analysis
- Interim analysis with DSMB
Tahukah Anda?
Large-scale (1,000-5,000+ patients) randomized controlled trials confirming efficacy and monitoring adverse reactions. Pivotal for regulatory submission. Often multicenter, international, and double-blind.