方法对比
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| 前瞻性IV期研究× | 病例对照研究× | |
|---|---|---|
| 领域 | 流行病学 | 流行病学 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 1970s–1980s (formalized in post-marketing regulatory frameworks) | 1950s (formal methodology); precursors in the 1920s |
| 提出者≠ | Regulatory and pharmaceutical research community (ICH E2E, EMA PASS guidelines) | Janet Lane-Claypon (early precursors, 1926); formalized by Brian MacMahon and Jerome Cornfield in the 1950s–1960s |
| 类型≠ | Observational / interventional post-marketing study design | Observational analytic study design |
| 开创性文献≠ | Strom, B.L. (Ed.). (2005). Pharmacoepidemiology (4th ed.). Wiley. ISBN: 978-0470863088 | Schlesselman, J.J. (1982). Case-Control Studies: Design, Conduct, Analysis. Oxford University Press. ISBN: 978-0195027860 |
| 别名 | prospective post-marketing surveillance study, prospective pharmacovigilance study, prospective post-authorization safety study, PASS (prospective) | case-referent study, case-control design, retrospective case-control, case-control analysis |
| 相关≠ | 5 | 6 |
| 摘要≠ | A prospective Phase IV study is a post-marketing investigation conducted after a drug, device, or intervention has received regulatory approval, following participants forward in real time to collect safety, effectiveness, and utilization data under routine clinical practice conditions. Unlike retrospective designs that mine existing records, prospective enrollment allows pre-specified data collection, defined follow-up windows, and direct measurement of outcomes as they occur, making it central to post-authorization safety surveillance and long-term effectiveness research. | A case-control study is a retrospective observational design in which individuals who have developed a disease or outcome of interest (cases) are compared with individuals who have not (controls) to determine whether prior exposure to a putative risk factor differs between the two groups. The primary measure of association is the odds ratio, which approximates the relative risk when the outcome is rare. Case-control studies are especially efficient for investigating rare diseases and generating etiological hypotheses. |
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