So sánh phương pháp

	Giai đoạn III Thử nghiệm lâm sàng	Thử nghiệm lâm sàng Giai đoạn II
Lĩnh vực	Dịch tễ học	Dịch tễ học
Họ	Process / pipeline	Process / pipeline
Năm ra đời	1962 (Kefauver-Harris Amendment formalised phased drug development)	1960s–1970s (formalised in US federal drug regulation)
Người khởi xướng	FDA regulatory framework / ICH guidelines	U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework)
Loại	Confirmatory randomised controlled trial	Interventional clinical study design
Công trình gốc	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
Tên gọi khác	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial
Liên quan	6	6
Tóm tắt	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.