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| 임상 1상 시험× | 적응형 무작위 배정 임상시험× | |
|---|---|---|
| 분야 | 역학 | 역학 |
| 계열 | Process / pipeline | Process / pipeline |
| 기원 연도≠ | 1960s (formal regulatory framework established ~1963–1970s) | Late 1990s–2000s (widespread adoption post-2010) |
| 창시자≠ | 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 |
| 유형≠ | Interventional clinical study design | Experimental clinical trial design |
| 원전≠ | Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. DOI ↗ | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| 별칭 | Phase 1 trial, first-in-human study, FIH study, dose-escalation study | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| 관련 | 6 | 6 |
| 요약≠ | 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. |
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