השוואת שיטות

	ניסוי קליני רב-מרכזי שלב I	ניסוי קליני שלב II
תחום	אפידמיולוגיה	אפידמיולוגיה
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1970s–1980s (formalized in FDA Phase I guidance 1977; ICH E6 GCP 1996)	1960s–1970s (formalised in US federal drug regulation)
הוגה השיטה	Established through FDA regulatory guidance and ICH harmonization frameworks	U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework)
סוג	Interventional clinical study design	Interventional clinical study design
מקור מכונן	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). ICH.	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
כינויים	multisite Phase I trial, multi-institutional Phase I study, Phase I dose-escalation multicenter study, first-in-human multicenter trial	Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial
קשורות	6	6
תקציר	A multicenter Phase I clinical trial is the first systematic administration of an investigational agent to humans, conducted simultaneously across two or more clinical sites. Its primary objectives are to characterize the safety and tolerability profile of the intervention, determine the maximum tolerated dose (MTD), and describe pharmacokinetic and pharmacodynamic behavior. Distributing enrollment across sites increases participant accrual speed and enhances the generalizability of early-phase safety data.	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.