So sánh phương pháp

	Thử nghiệm lâm sàng Giai đoạn III hồi cứu	Thử nghiệm lâm sàng ngẫu nhiên (RCT)
Lĩnh vực	Dịch tễ học	Dịch tễ học
Họ	Process / pipeline	Process / pipeline
Năm ra đời	Late 20th century (ICH E8 1997; widespread retrospective Phase III use from 1990s onward)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
Người khởi xướng	Regulatory framework codified by ICH E8/E9 (1997–1998); retrospective application developed through post-marketing and registry practice	Austin Bradford Hill; MRC Streptomycin Trial team
Loại	Retrospective comparative clinical study	Interventional experimental study
Công trình gốc	Friedman, L. M., Furberg, C. D., & DeMets, D. L. (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN: 978-1441915856	Friedman, 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
Tên gọi khác	retrospective Phase III study, historical Phase III trial, Phase III retrospective analysis, retrospective comparative efficacy trial	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Liên quan	5	6
Tóm tắt	A retrospective Phase III clinical trial evaluates the comparative efficacy and safety of an intervention against a control using data that were collected before the study was designed. Rather than enrolling new patients prospectively, researchers analyze existing records — from registries, hospital databases, or historical trial archives — to address a Phase III-level question: does Treatment A outperform the current standard of care in a large, representative patient population? This design is used when prospective enrollment is infeasible, unethical, or when historical data are sufficiently complete to support a rigorous comparison.	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.