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II faasi kliiniline uuring×Randomiseeritud kontrollitud uuring (RCT)×
ValdkondEpidemioloogiaEpidemioloogia
PerekondProcess / pipelineProcess / pipeline
Tekkeaasta1960s–1970s (formalised in US federal drug regulation)1948 (first rigorously conducted RCT — MRC streptomycin trial)
LoojaU.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework)Austin Bradford Hill; MRC Streptomycin Trial team
TüüpInterventional clinical study designInterventional 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: 978-3319185392Friedman, 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 2 trial, Phase II study, early efficacy trial, proof-of-concept trialRCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Seotud66
KokkuvõteA Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment.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 II clinical trial · Randomized clinical trial. Loetud 2026-06-19 aadressilt https://scholargate.app/et/compare