เปรียบเทียบวิธี

	การทดลองทางคลินิกระยะที่ 3	การทดลองทางคลินิกระยะสุ่มแบบหลายศูนย์ (Multicenter Randomized Clinical Trial
สาขาวิชา	ระบาดวิทยา	ระบาดวิทยา
ตระกูล	Process / pipeline	Process / pipeline
ปีกำเนิด	1962 (Kefauver-Harris Amendment formalised phased drug development)	1970s–1980s (widespread adoption for large-scale efficacy trials)
ผู้ริเริ่ม	FDA regulatory framework / ICH guidelines	Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980s
ประเภท	Confirmatory randomised controlled trial	Interventional experimental design
แหล่งต้นตำรับ	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
ชื่อเรียกอื่น	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial
ที่เกี่ยวข้อง	6	6
สรุป	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 multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments.