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Etapp III kliiniline uuring×Kohortuuring×
ValdkondEpidemioloogiaEpidemioloogia
PerekondProcess / pipelineProcess / pipeline
Tekkeaasta1962 (Kefauver-Harris Amendment formalised phased drug development)Mid-20th century (formal epidemiological design codified ~1950s)
LoojaFDA regulatory framework / ICH guidelinesDoll & Hill (British Doctors Study, 1951); Snow (cholera, 1854)
TüüpConfirmatory randomised controlled trialObservational longitudinal study design
AlgallikasFriedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
RööpnimetusedPhase 3 trial, confirmatory trial, pivotal trial, Phase III RCTlongitudinal study, follow-up study, panel study, incidence study
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 cohort study assembles a group of individuals who share a common starting point — typically freedom from the outcome of interest — and follows them over time to observe who develops the outcome. By comparing incidence rates between exposed and unexposed subgroups, researchers can estimate relative risk and absolute risk differences. Cohort studies are the gold-standard observational design for measuring disease incidence and establishing temporal relationships between exposure and outcome.
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ScholarGateVõrdle meetodeid: Phase III clinical trial · Cohort Study. Loetud 2026-06-19 aadressilt https://scholargate.app/et/compare