手法を比較

	実薬フェーズIV試験	スクリーニング検査評価
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1967 (pragmatic concept); 2000s (pragmatic Phase IV formalized)	1968 (Wilson-Jungner principles); statistical framework developed 1970s–2000s
提唱者	Schwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); PRECIS framework by Thorpe et al. (2009)	Wilson & Jungner (WHO criteria, 1968); foundational work by Pepe, Altman, and others in statistical test evaluation
種類	Observational / interventional hybrid study design	Observational diagnostic / epidemiological evaluation design
原典	Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Chalkidou, K. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology, 62(5), 464-475.	Wilson, J. M. G., & Jungner, G. (1968). Principles and Practice of Screening for Disease. World Health Organization. Public Health Papers No. 34.
別名	pragmatic post-marketing study, real-world phase IV trial, pragmatic pharmacovigilance study, pragmatic post-approval study	screening study, screening performance evaluation, screening accuracy assessment, STE
関連	5	6
概要	A pragmatic Phase IV study is a post-marketing investigation conducted under routine clinical conditions to evaluate a drug or device's real-world effectiveness, long-term safety, and comparative performance. Unlike the controlled Phase III environment, it intentionally minimizes protocol restrictions — broad eligibility criteria, standard-of-care comparators, and naturalistic follow-up — to generate evidence directly applicable to everyday clinical practice.	Screening test evaluation is a systematic epidemiological approach for assessing whether a test or program can accurately and cost-effectively identify individuals with a condition before symptoms appear. It quantifies diagnostic performance metrics — sensitivity, specificity, predictive values, and the ROC curve — and evaluates whether a screening program meets established public health criteria for adoption and harm-benefit balance.