手法を比較

	第I相臨床試験	フェーズIII臨床試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1960s (formal regulatory framework established ~1963–1970s)	1962 (Kefauver-Harris Amendment formalised phased drug development)
提唱者	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines	FDA regulatory framework / ICH guidelines
種類	Interventional clinical study design	Confirmatory randomised controlled trial
原典	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
別名	Phase 1 trial, first-in-human study, FIH study, dose-escalation study	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
関連	6	6
概要	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.