Сравнение на методи

	Мултицентрово клинично изпитване Фаза I	Клинично изпитване Фаза I
Област	Епидемиология	Епидемиология
Семейство	Process / pipeline	Process / pipeline
Година на възникване	1970s–1980s (formalized in FDA Phase I guidance 1977; ICH E6 GCP 1996)	1960s (formal regulatory framework established ~1963–1970s)
Създател	Established through FDA regulatory guidance and ICH harmonization frameworks	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines
Тип	Interventional clinical study design	Interventional clinical study design
Основополагащ източник	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). ICH.	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.
Други названия	multisite Phase I trial, multi-institutional Phase I study, Phase I dose-escalation multicenter study, first-in-human multicenter trial	Phase 1 trial, first-in-human study, FIH study, dose-escalation study
Свързани	6	6
Резюме	A multicenter Phase I clinical trial is the first systematic administration of an investigational agent to humans, conducted simultaneously across two or more clinical sites. Its primary objectives are to characterize the safety and tolerability profile of the intervention, determine the maximum tolerated dose (MTD), and describe pharmacokinetic and pharmacodynamic behavior. Distributing enrollment across sites increases participant accrual speed and enhances the generalizability of early-phase safety data.	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.