Comparar métodos

	Ensaio Clínico Randomizado Prospectivo	Estudo de Confirmação Fundamental (Fase III)
Área	Epidemiologia	Epidemiologia
Família	Process / pipeline	Process / pipeline
Ano de origem	1948 (landmark MRC streptomycin trial)	1962 (Kefauver-Harris Amendment formalised phased drug development)
Autor original	Austin Bradford Hill / Medical Research Council	FDA regulatory framework / ICH guidelines
Tipo	Experimental / interventional study design	Confirmatory randomised controlled trial
Fonte seminal	Medical Research Council (1948). Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. British Medical Journal, 2(4582), 769–782.	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	Prospective RCT, randomized controlled trial, RCT, controlled clinical trial	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
Relacionados	5	6
Resumo	A prospective randomized clinical trial (RCT) is an experimental study in which participants are assigned to intervention or control groups by chance before any outcomes are observed, then followed forward in time. Random allocation eliminates systematic selection bias, making this design the gold standard for establishing causal efficacy of treatments in medicine and clinical research.	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.