Metodebevisregistrering

Phase III clinical trial

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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Kilderegistrering

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Phase III Confirmatory Clinical Trial

Taksonomisk metoderegistrering · process-pipeline / epidemiology

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. · URL

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