Сравнение методов
Просматривайте выбранные методы рядом; строки с различиями подсвечены.
| Исследование Фазы IV с поправкой на риск× | Когортное исследование× | |
|---|---|---|
| Область | Эпидемиология | Эпидемиология |
| Семейство | Process / pipeline | Process / pipeline |
| Год появления≠ | 1990s–2000s (formalized with ICH E2E and EMA PASS guidelines) | Mid-20th century (formal epidemiological design codified ~1950s) |
| Автор метода≠ | Regulatory and pharmacoepidemiology community (ICH, EMA, FDA frameworks) | Doll & Hill (British Doctors Study, 1951); Snow (cholera, 1854) |
| Тип≠ | Observational / quasi-experimental clinical study design | Observational longitudinal study design |
| Основополагающий источник≠ | Strom, B. L. (Ed.). (2005). Pharmacoepidemiology (4th ed.). John Wiley & Sons. ISBN: 978-0470863107 | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| Другие названия | risk-adjusted post-marketing surveillance study, adjusted Phase IV trial, risk-stratified post-authorization study, PASS with risk adjustment | longitudinal study, follow-up study, panel study, incidence study |
| Связанные≠ | 3 | 6 |
| Сводка≠ | A risk-adjusted Phase IV study is an observational or semi-experimental post-marketing study conducted after a drug or device has received regulatory approval. It uses statistical risk-adjustment techniques — such as propensity score matching, inverse probability weighting, or multivariable regression — to control for confounding by indication and baseline patient differences, thereby producing more credible safety, effectiveness, and utilization estimates than unadjusted real-world analyses. | A cohort study assembles a group of individuals who share a common starting point — typically freedom from the outcome of interest — and follows them over time to observe who develops the outcome. By comparing incidence rates between exposed and unexposed subgroups, researchers can estimate relative risk and absolute risk differences. Cohort studies are the gold-standard observational design for measuring disease incidence and establishing temporal relationships between exposure and outcome. |
| ScholarGateНабор данных ↗ |
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