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.
例
- Superiority vs non-inferiority
- Intent-to-treat analysis
- Interim analysis with DSMB
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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.