手法を比較

	多施設共同第IV相試験	多施設共同無作為化臨床試験
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)	1970s–1980s (widespread adoption for large-scale efficacy trials)
提唱者	Regulatory agencies and pharmaceutical industry (ICH E2E, FDA, EMA post-marketing frameworks)	Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980s
種類	Observational or interventional post-marketing study	Interventional experimental design
原典	Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. John Wiley & Sons. ISBN: 978-0470029619	Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385
別名	multicenter post-marketing study, multicenter pharmacovigilance study, multi-site phase IV study, post-authorization safety study	multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial
関連	6	6
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.	A multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments.