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Thử nghiệm lâm sàng Giai đoạn III điều chỉnh theo rủi ro×Thử nghiệm lâm sàng ngẫu nhiên thích ứng×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1980s–presentLate 1990s–2000s (widespread adoption post-2010)
Người khởi xướngEvolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialistsDonald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
LoạiConfirmatory randomized trial with baseline risk stratification and covariate adjustmentExperimental clinical trial design
Công trình gốcPocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley. ISBN: 978-0471901556Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
Tên gọi khácrisk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase IIIadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
Liên quan66
Tóm tắtA risk-adjusted Phase III clinical trial is a large-scale confirmatory randomized experiment that explicitly incorporates participants' baseline prognostic risk profile into both the randomization process and the primary statistical analysis. By stratifying patients on known risk factors before allocation and adjusting for those factors in the outcome model, the design achieves greater statistical precision, reduces confounding, and produces treatment effect estimates that are more clinically meaningful across patient subgroups.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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ScholarGateSo sánh phương pháp: Risk-adjusted Phase III clinical trial · Adaptive Randomized Clinical Trial. Truy cập ngày 2026-06-20 từ https://scholargate.app/vi/compare