手法を比較

	第I相臨床試験	適応的無作為化比較試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1960s (formal regulatory framework established ~1963–1970s)	Late 1990s–2000s (widespread adoption post-2010)
提唱者	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
種類	Interventional clinical study design	Experimental clinical trial design
原典	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.
別名	Phase 1 trial, first-in-human study, FIH study, dose-escalation study	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
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.	An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.