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Retrospective phase III clinical trial

A retrospective Phase III clinical trial evaluates the comparative efficacy and safety of an intervention against a control using data that were collected before the study was designed. Rather than enrolling new patients prospectively, researchers analyze existing records — from registries, hospital databases, or historical trial archives — to address a Phase III-level question: does Treatment A outperform the current standard of care in a large, representative patient population? This design is used when prospective enrollment is infeasible, unethical, or when historical data are sufficiently complete to support a rigorous comparison.

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Retrospective Phase III Clinical Trial

Taxonomisk metodpost · process-pipeline / epidemiology

Friedman, L. M., Furberg, C. D., & DeMets, D. L. (2010). Fundamentals of Clinical Trials (4th ed.). Springer. · ISBN 978-1441915856
International Conference on Harmonisation. (1998). ICH E9: Statistical Principles for Clinical Trials. Federal Register, 63(179), 49583–49598. · URL

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