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Etapp III kliiniline uuring×Randomiseeritud kontrollitud uuring (RCT)×
ValdkondEpidemioloogiaEpidemioloogia
PerekondProcess / pipelineProcess / pipeline
Tekkeaasta1962 (Kefauver-Harris Amendment formalised phased drug development)1948 (first rigorously conducted RCT — MRC streptomycin trial)
LoojaFDA regulatory framework / ICH guidelinesAustin Bradford Hill; MRC Streptomycin Trial team
TüüpConfirmatory randomised controlled trialInterventional experimental study
AlgallikasFriedman, 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
RööpnimetusedPhase 3 trial, confirmatory trial, pivotal trial, Phase III RCTRCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Seotud66
KokkuvõteA 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.A 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.
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ScholarGateVõrdle meetodeid: Phase III clinical trial · Randomized clinical trial. Loetud 2026-06-19 aadressilt https://scholargate.app/et/compare