השוואת שיטות

	ניסוי קליני שלב I	שלב III ניסוי קליני
תחום	אפידמיולוגיה	אפידמיולוגיה
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1960s (formal regulatory framework established ~1963–1970s)	1962 (Kefauver-Harris Amendment formalised phased drug development)
הוגה השיטה	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines	FDA regulatory framework / ICH guidelines
סוג	Interventional clinical study design	Confirmatory randomised controlled trial
מקור מכונן	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.	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
כינויים	Phase 1 trial, first-in-human study, FIH study, dose-escalation study	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
קשורות	6	6
תקציר	A Phase I clinical trial is the first stage of human testing for a new drug, biologic, or intervention. Its primary objective is to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) rather than therapeutic efficacy. Small cohorts of participants — typically healthy volunteers or patients with advanced disease — receive sequentially increasing doses to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) that define the boundary for subsequent trials.	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.