เปรียบเทียบวิธี

	การทดลองทางคลินิกระยะที่ II	การทดลองทางคลินิกแบบสุ่ม (RCT)
สาขาวิชา	ระบาดวิทยา	ระบาดวิทยา
ตระกูล	Process / pipeline	Process / pipeline
ปีกำเนิด	1960s–1970s (formalised in US federal drug regulation)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
ผู้ริเริ่ม	U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework)	Austin Bradford Hill; MRC Streptomycin Trial team
ประเภท	Interventional clinical study design	Interventional experimental study
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: 978-3319185392	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 2 trial, Phase II study, early efficacy trial, proof-of-concept trial	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
ที่เกี่ยวข้อง	6	6
สรุป	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.	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.