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Essai clinique de phase II apparié×Étude cas-témoins appariée×
DomaineÉpidémiologieÉpidémiologie
FamilleProcess / pipelineProcess / pipeline
Année d'origine1960s–1980s (formalized with Simon optimal designs, 1989)1950s–1970s
Auteur d'origineGehan (1961) for Phase II designs; matching frameworks adapted from case-control methodologyBrian MacMahon and others; systematised by Schlesselman (1982)
TypeControlled clinical trial designObservational analytic design
Source fondatriceGehan, 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
Aliasmatched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trialmatched case-referent study, individually matched case-control, pair-matched case-control, matched case-control design
Apparentées55
RésuméA 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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ScholarGateComparer des méthodes: Matched Phase II clinical trial · Matched case-control study. Consulté le 2026-06-18 sur https://scholargate.app/fr/compare