Comparar métodos

	Ensayo Clínico Fase I	Ensayo Clínico Aleatorizado (ECA)
Campo	Epidemiología	Epidemiología
Familia	Process / pipeline	Process / pipeline
Año de origen	1960s (formal regulatory framework established ~1963–1970s)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
Autor original	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines	Austin Bradford Hill; MRC Streptomycin Trial team
Tipo	Interventional clinical study design	Interventional experimental study
Fuente seminal	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.	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
Alias	Phase 1 trial, first-in-human study, FIH study, dose-escalation study	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Relacionados	6	6
Resumen	A Phase I clinical trial is the first stage of human testing for a new drug, biologic, or intervention. Its primary objective is to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) rather than therapeutic efficacy. Small cohorts of participants — typically healthy volunteers or patients with advanced disease — receive sequentially increasing doses to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) that define the boundary for subsequent trials.	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.