เปรียบเทียบวิธี

	การศึกษาทางคลินิกระยะที่ 1	การออกแบบการศึกษาความแม่นยำในการวินิจฉัย
สาขาวิชา	ระบาดวิทยา	การวิจัยทางคลินิก
ตระกูล	Process / pipeline	Process / pipeline
ปีกำเนิด	1960s (formal regulatory framework established ~1963–1970s)	2003-2015
ผู้ริเริ่ม	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines	Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers
ประเภท	Interventional clinical study design	Research Design
แหล่งต้นตำรับ	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.	Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., ... & de Vet, H. C. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Annals of Internal Medicine, 138(1), 40–44.
ชื่อเรียกอื่น	Phase 1 trial, first-in-human study, FIH study, dose-escalation study	diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation
ที่เกี่ยวข้อง	6	2
สรุป	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 diagnostic accuracy study evaluates how well a new diagnostic test (or biomarker, imaging modality, clinical assessment) detects the presence or absence of disease compared to a reference standard (gold standard). Standardized since 2003 by the STARD (Standards for Reporting of Diagnostic Accuracy Studies) initiative, diagnostic accuracy studies are fundamental to clinical medicine, determining whether and how new tests can improve patient diagnosis and treatment.