手法を比較

	後向き第III相臨床試験	生存時間解析
分野	疫学	研究統計
系統	Process / pipeline	Process / pipeline
提唱年	Late 20th century (ICH E8 1997; widespread retrospective Phase III use from 1990s onward)	1958
提唱者	Regulatory framework codified by ICH E8/E9 (1997–1998); retrospective application developed through post-marketing and registry practice	Edward L. Kaplan and Paul Meier
種類	Retrospective comparative clinical study	Method
原典	Friedman, L. M., Furberg, C. D., & DeMets, D. L. (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN: 978-1441915856	Kaplan, E. L., & Meier, P. (1958). Nonparametric estimation from incomplete observations. Journal of the American Statistical Association, 53(282), 457–481.
別名	retrospective Phase III study, historical Phase III trial, Phase III retrospective analysis, retrospective comparative efficacy trial	Kaplan-Meier analysis, Cox regression, TTE analysis
関連	5	3
概要	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.	Survival analysis is a collection of statistical methods for modeling time from a defined starting point until an event of interest occurs (disease, recovery, death, equipment failure). Kaplan and Meier's nonparametric estimator (1958) and David Cox's proportional hazards model (1972) jointly enabled analysis of censored data—individuals whose event times are unknown because they left the study or were still event-free at follow-up. Indispensable in oncology, cardiology, infectious disease research, engineering reliability, and any field where time-to-event matters.