Comparar métodos

	Estudo de Confirmação Fundamental (Fase III)	Ensaio Clínico Randomizado (ECR)
Área	Epidemiologia	Epidemiologia
Família	Process / pipeline	Process / pipeline
Ano de origem	1962 (Kefauver-Harris Amendment formalised phased drug development)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
Autor original	FDA regulatory framework / ICH guidelines	Austin Bradford Hill; MRC Streptomycin Trial team
Tipo	Confirmatory randomised controlled trial	Interventional experimental study
Fonte seminal	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
Outros nomes	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Relacionados	6	6
Resumo	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.