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	Fas III klinisk prövning – Konfirmerande pivotal studie	Randomiserad klinisk prövning (RCT)
Ämnesområde	Epidemiologi	Epidemiologi
Familj	Process / pipeline	Process / pipeline
Ursprungsår	1962 (Kefauver-Harris Amendment formalised phased drug development)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
Upphovsperson	FDA regulatory framework / ICH guidelines	Austin Bradford Hill; MRC Streptomycin Trial team
Typ	Confirmatory randomised controlled trial	Interventional experimental study
Ursprungskälla	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
Alias	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Närliggande	6	6
Sammanfattning	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.