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المرحلة الثالثة من التجارب السريرية×تجربة سريرية عشوائية تكيفية×
المجالعلم الأوبئةعلم الأوبئة
العائلةProcess / pipelineProcess / pipeline
سنة النشأة1962 (Kefauver-Harris Amendment formalised phased drug development)Late 1990s–2000s (widespread adoption post-2010)
صاحب الطريقةFDA regulatory framework / ICH guidelinesDonald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
النوعConfirmatory randomised controlled trialExperimental clinical trial design
المصدر التأسيسيFriedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
الأسماء البديلةPhase 3 trial, confirmatory trial, pivotal trial, Phase III RCTadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
ذات صلة66
الملخصA 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.An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.
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ScholarGateقارن الطرق: Phase III clinical trial · Adaptive Randomized Clinical Trial. استُرجع بتاريخ 2026-06-19 من https://scholargate.app/ar/compare