Сравнение методов

	Фаза III клинического исследования	Рандомизированное контролируемое испытание (РКИ)
Область	Эпидемиология	Эпидемиология
Семейство	Process / pipeline	Process / pipeline
Год появления	1962 (Kefauver-Harris Amendment formalised phased drug development)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
Автор метода	FDA regulatory framework / ICH guidelines	Austin Bradford Hill; MRC Streptomycin Trial team
Тип	Confirmatory randomised controlled trial	Interventional experimental study
Основополагающий источник	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
Другие названия	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Связанные	6	6
Сводка	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 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.