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| 무작위 임상시험 (RCT)× | Phase III 임상시험× | |
|---|---|---|
| 분야 | 역학 | 역학 |
| 계열 | Process / pipeline | Process / pipeline |
| 기원 연도≠ | 1948 (first rigorously conducted RCT — MRC streptomycin trial) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| 창시자≠ | Austin Bradford Hill; MRC Streptomycin Trial team | FDA regulatory framework / ICH guidelines |
| 유형≠ | Interventional experimental study | Confirmatory randomised controlled trial |
| 원전 | 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 | 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 |
| 별칭 | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| 관련 | 6 | 6 |
| 요약≠ | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. | 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. |
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