手法を比較

	多施設共同第I相臨床試験	用量反応分析
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1970s–1980s (formalized in FDA Phase I guidance 1977; ICH E6 GCP 1996)	Conceptual roots 16th century; modern epidemiological application mid-20th century
提唱者	Established through FDA regulatory guidance and ICH harmonization frameworks	Paracelsus (conceptual foundation); formalized by John Snow and later Bradford Hill
種類	Interventional clinical study design	Quantitative analytical method
原典	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.	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
別名	multisite Phase I trial, multi-institutional Phase I study, Phase I dose-escalation multicenter study, first-in-human multicenter trial	exposure-response analysis, concentration-response modeling, dose-response modeling, DRA
関連	6	4
概要	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.	Dose-response analysis quantifies the relationship between the magnitude of an exposure (the dose) and the probability or rate of an outcome (the response). It is a core analytical strategy in epidemiology and toxicology, providing evidence that increasing exposure systematically increases — or decreases — the risk of disease. A demonstrated dose-response gradient is one of Bradford Hill's classic criteria supporting causal inference.