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| Μελέτη Φάσης IV με Ζεύγη× | Αντιστοίχιση Βαθμολογίας Προδιάθεσης× | |
|---|---|---|
| Πεδίο≠ | Επιδημιολογία | Ερευνητική Στατιστική |
| Οικογένεια | Process / pipeline | Process / pipeline |
| Έτος προέλευσης≠ | 1980s–1990s (formalized in post-marketing regulatory frameworks) | 1983 |
| Δημιουργός≠ | Regulatory tradition (FDA, EMA); matching methodology from Rosenbaum & Rubin (1983) | Paul Rosenbaum and Donald Rubin |
| Τύπος≠ | Observational study design | Method |
| Θεμελιώδης πηγή≠ | Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. Wiley. ISBN: 978-0470029244 | Rosenbaum, 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 ↗ |
| Εναλλακτικές ονομασίες≠ | matched post-marketing surveillance study, Phase IV matched cohort study, matched pharmacoepidemiological study, post-authorization matched safety study | PSM, propensity score weighting, covariate balance |
| Συναφείς≠ | 5 | 3 |
| Σύνοψη≠ | A 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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