Comparar métodos

	Ensayo clínico de fase III	Fase II Ensayo Clínico
Campo	Epidemiología	Epidemiología
Familia	Process / pipeline	Process / pipeline
Año de origen	1962 (Kefauver-Harris Amendment formalised phased drug development)	1960s–1970s (formalised in US federal drug regulation)
Autor original	FDA regulatory framework / ICH guidelines	U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework)
Tipo	Confirmatory randomised controlled trial	Interventional clinical study design
Fuente 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: 978-3319185392
Alias	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial
Relacionados	6	6
Resumen	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 Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment.