Defined term · Trial design and conduct
Phase 3
Confirmatory clinical development, adequately powered for a pre-specified primary endpoint in the population for which authorisation is sought.
§1Phase 3
§1.2Category
Trial design and conduct — Terms describing how a clinical study is constructed and run.
§1.3Related terms
- Phase 2 — Exploratory clinical development establishing dose and preliminary efficacy. Phase 2 estimates in selected populations are systematically larger than the confirmatory…
Compound Evidence Institute · CEI-GT-062 · https://compoundevidence.com/glossary/phase-3/ · retrieved 30 July 2026