手法を比較

	第IV相試験	症例対照研究
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	Formalised 1970s–1990s (ICH E3 guideline 1994)	1950s (formal methodology); precursors in the 1920s
提唱者	Regulatory agencies and pharmaceutical industry (ICH, FDA, EMA frameworks)	Janet Lane-Claypon (early precursors, 1926); formalized by Brian MacMahon and Jerome Cornfield in the 1950s–1960s
種類	Post-marketing observational or interventional study	Observational analytic study design
原典	International Conference on Harmonisation (ICH). (1994). ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. ICH Secretariat.	Schlesselman, J.J. (1982). Case-Control Studies: Design, Conduct, Analysis. Oxford University Press. ISBN: 978-0195027860
別名	post-marketing surveillance study, post-approval study, Phase 4 study, PMS study	case-referent study, case-control design, retrospective case-control, case-control analysis
関連	5	6
概要	A Phase IV study is a post-marketing surveillance study conducted after a drug, device, or intervention has received regulatory approval. Its primary purpose is to monitor long-term safety, detect rare adverse events, assess effectiveness in routine clinical practice, and explore new indications or populations not adequately represented in earlier trials. Phase IV evidence accumulates continuously throughout a product's commercial life.	A case-control study is a retrospective observational design in which individuals who have developed a disease or outcome of interest (cases) are compared with individuals who have not (controls) to determine whether prior exposure to a putative risk factor differs between the two groups. The primary measure of association is the odds ratio, which approximates the relative risk when the outcome is rare. Case-control studies are especially efficient for investigating rare diseases and generating etiological hypotheses.