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| フェーズIII臨床試験× | コホート研究× | |
|---|---|---|
| 分野 | 疫学 | 疫学 |
| 系統 | Process / pipeline | Process / pipeline |
| 提唱年≠ | 1962 (Kefauver-Harris Amendment formalised phased drug development) | Mid-20th century (formal epidemiological design codified ~1950s) |
| 提唱者≠ | FDA regulatory framework / ICH guidelines | Doll & Hill (British Doctors Study, 1951); Snow (cholera, 1854) |
| 種類≠ | Confirmatory randomised controlled trial | Observational longitudinal study design |
| 原典≠ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| 別名 | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT | longitudinal study, follow-up study, panel study, incidence study |
| 関連 | 6 | 6 |
| 概要≠ | A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption. | 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. |
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