Process / pipelineClinical / epidemiology
Phase III Clinical Trial — Confirmatory Pivotal Study
A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption.
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Sources
- Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385
- International Council for Harmonisation (ICH). (1997). E8 General Considerations for Clinical Trials. ICH Harmonised Guideline. link ↗
Related methods
Referenced by
Adaptive Phase III clinical trialAdaptive Randomized Clinical TrialBayesian Phase III Clinical TrialMatched Phase III Clinical TrialMulticenter phase II clinical trialMulticenter Randomized Clinical TrialPhase I Clinical TrialPhase II clinical trialPhase IV studyProspective Randomized Clinical TrialRandomized clinical trialRetrospective phase II clinical trialRetrospective phase III clinical trialRisk-adjusted Phase III clinical trial