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Badanie kliniczne z randomizacją (RCT)×Badanie kliniczne fazy III×
DziedzinaEpidemiologiaEpidemiologia
RodzinaProcess / pipelineProcess / pipeline
Rok powstania1948 (first rigorously conducted RCT — MRC streptomycin trial)1962 (Kefauver-Harris Amendment formalised phased drug development)
TwórcaAustin Bradford Hill; MRC Streptomycin Trial teamFDA regulatory framework / ICH guidelines
TypInterventional experimental studyConfirmatory randomised controlled trial
Źródło pierwotneFriedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385Friedman, 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
Inne nazwyRCT, randomized controlled trial, randomised controlled trial, clinical randomized trialPhase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
Pokrewne66
PodsumowanieA randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions.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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  3. PUBLISHED
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  3. PUBLISHED

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ScholarGatePorównaj metody: Randomized clinical trial · Phase III clinical trial. Pobrano 2026-06-19 z https://scholargate.app/pl/compare