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Zhodná štúdia fázy IV×Zodpovedajúce skóre sklonu×
OdborEpidemiológiaŠtatistika vo výskume
RodinaProcess / pipelineProcess / pipeline
Rok vzniku1980s–1990s (formalized in post-marketing regulatory frameworks)1983
TvorcaRegulatory tradition (FDA, EMA); matching methodology from Rosenbaum & Rubin (1983)Paul Rosenbaum and Donald Rubin
TypObservational study designMethod
Pôvodný zdrojStrom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. Wiley. ISBN: 978-0470029244Rosenbaum, P. R., & Rubin, D. B. (1983). The central role of the propensity score in observational studies for causal effects. Biometrika, 70(1), 41–55. DOI ↗
Ďalšie názvymatched post-marketing surveillance study, Phase IV matched cohort study, matched pharmacoepidemiological study, post-authorization matched safety studyPSM, propensity score weighting, covariate balance
Príbuzné53
ZhrnutieA Matched Phase IV study is a post-marketing observational design in which patients who received an approved drug (or intervention) are matched to comparable non-exposed patients — or patients on an alternative therapy — to evaluate real-world safety, effectiveness, or long-term outcomes. Conducted after regulatory approval, it combines the epidemiological rigour of matching with the breadth of post-authorization pharmacovigilance, generating evidence that randomized trials are rarely powered or timed to provide.Propensity score matching (PSM) is a method for reducing confounding bias in observational studies by balancing baseline characteristics between treatment groups, simulating randomization. Developed by Rosenbaum and Rubin (1983), it estimates the probability of receiving treatment given observed covariates, then matches or weights treated and control individuals with similar treatment probabilities. Widely used in medicine, epidemiology, and policy evaluation when randomized trials are infeasible or unethical, enabling estimation of treatment effects while controlling for selection bias.
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ScholarGatePorovnať metódy: Matched Phase IV Study · Propensity Score Matching. Získané 2026-06-18 z https://scholargate.app/sk/compare