Methoden vergelijken

	Fase III Klinische Studie	Gerandomiseerde klinische studie (GKS)
Vakgebied	Epidemiologie	Epidemiologie
Familie	Process / pipeline	Process / pipeline
Jaar van ontstaan	1962 (Kefauver-Harris Amendment formalised phased drug development)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
Grondlegger	FDA regulatory framework / ICH guidelines	Austin Bradford Hill; MRC Streptomycin Trial team
Type	Confirmatory randomised controlled trial	Interventional experimental study
Oorspronkelijke bron	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
Aliassen	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Verwant	6	6
Samenvatting	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.