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| 후향적 3상 임상시험× | 회고적 코호트 연구× | |
|---|---|---|
| 분야 | 역학 | 역학 |
| 계열 | Process / pipeline | Process / pipeline |
| 기원 연도≠ | Late 20th century (ICH E8 1997; widespread retrospective Phase III use from 1990s onward) | Mid-20th century (widely formalized 1950s–1970s) |
| 창시자≠ | Regulatory framework codified by ICH E8/E9 (1997–1998); retrospective application developed through post-marketing and registry practice | Systematic use attributed to early 20th-century occupational epidemiology; formalized in modern epidemiological theory by Brian MacMahon and others |
| 유형≠ | Retrospective comparative clinical study | Observational analytic study |
| 원전≠ | Friedman, L. M., Furberg, C. D., & DeMets, D. L. (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN: 978-1441915856 | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| 별칭 | retrospective Phase III study, historical Phase III trial, Phase III retrospective analysis, retrospective comparative efficacy trial | historical cohort study, non-concurrent cohort study, retrospective follow-up study, historical prospective study |
| 관련≠ | 5 | 6 |
| 요약≠ | 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 retrospective cohort study assembles a group of individuals who share a common starting point and reconstructs their exposure history and subsequent outcomes entirely from pre-existing records. Because the data have already been collected before the study begins, the design is far faster and cheaper than a prospective cohort; however, the researcher must work with whatever information was recorded at the time rather than collecting purpose-built measurements. |
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