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	Klinická štúdia fázy I	Návrh diagnostickej štúdie presnosti
Odbor	Epidemiológia	Klinický výskum
Rodina	Process / pipeline	Process / pipeline
Rok vzniku	1960s (formal regulatory framework established ~1963–1970s)	2003-2015
Tvorca	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
Typ	Interventional clinical study design	Research Design
Pôvodný zdroj	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.
Ďalšie názvy	Phase 1 trial, first-in-human study, FIH study, dose-escalation study	diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation
Príbuzné	6	2
Zhrnutie	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.