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| Kohorttimuotoinen vaiheen II kliininen tutkimus× | Paritettu tapausselä-kontrollitutkimus× | |
|---|---|---|
| Tieteenala | Epidemiologia | Epidemiologia |
| Menetelmäperhe | Process / pipeline | Process / pipeline |
| Syntyvuosi≠ | 1960s–1980s (formalized with Simon optimal designs, 1989) | 1950s–1970s |
| Kehittäjä≠ | Gehan (1961) for Phase II designs; matching frameworks adapted from case-control methodology | Brian MacMahon and others; systematised by Schlesselman (1982) |
| Tyyppi≠ | Controlled clinical trial design | Observational analytic design |
| Alkuperäislähde≠ | Gehan, E. A. (1961). The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases, 13(4), 346–353. DOI ↗ | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755474 |
| Rinnakkaisnimet | matched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trial | matched case-referent study, individually matched case-control, pair-matched case-control, matched case-control design |
| Liittyvät | 5 | 5 |
| Tiivistelmä≠ | A matched Phase II clinical trial is a single-arm or small-controlled early-efficacy study in which treated patients are paired with matched controls — drawn from historical databases, registries, or concurrent external cohorts — on key prognostic variables such as age, disease stage, and performance status. This design allows preliminary efficacy assessment without a concurrent randomized arm, trading randomization for feasibility while partially controlling for confounding through the matching process. | A matched case-control study is an observational epidemiological design in which each case (a person with the disease or outcome of interest) is paired with one or more controls (persons without the outcome) who share one or more characteristics — such as age, sex, or clinical setting — to control confounding. Exposure history is then compared between cases and their matched controls to estimate the odds ratio of the exposure-disease association. |
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