手法を比較

	多施設共同第IV相試験	用量反応分析
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1980s–1990s (formalized with post-marketing requirements in modern drug regulation)	Conceptual roots 16th century; modern epidemiological application mid-20th century
提唱者	Regulatory agencies and pharmaceutical industry (ICH E2E, FDA, EMA post-marketing frameworks)	Paracelsus (conceptual foundation); formalized by John Snow and later Bradford Hill
種類	Observational or interventional post-marketing study	Quantitative analytical method
原典	Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. John Wiley & Sons. ISBN: 978-0470029619	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
別名	multicenter post-marketing study, multicenter pharmacovigilance study, multi-site phase IV study, post-authorization safety study	exposure-response analysis, concentration-response modeling, dose-response modeling, DRA
関連	6	4
概要	A multicenter Phase IV study is a post-marketing surveillance investigation conducted simultaneously at two or more clinical or research sites after a drug, device, or intervention has received regulatory approval. By pooling real-world data from diverse patient populations and geographic regions, it detects rare adverse events, evaluates long-term effectiveness, characterizes safety in subgroups, and fulfills regulatory post-authorization commitments that single-site studies cannot achieve.	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.