手法を比較

	レジストリベース研究	実践的臨床試験
分野	臨床研究	臨床研究
系統	Process / pipeline	Process / pipeline
提唱年	2000s-present	2009-2015
提唱者	Patient registries began mid-20th century; modern registry research formalized 2000s–2010s	Thorpe et al. (2009); PRECIS framework developed by international consortia
種類	Research Design	Research Design
原典	Gini, R., Francesconi, P., Mazzaglia, G., Brignoli, G., Cricelli, C., Lapi, F., & Cricelli, A. (2020). Chronic disease prevalence from Italian administrative databases: the PREVALENTIST study. BMC Public Health, 13, 191.	Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Tugwell, P. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 180(10), E47–E57.
別名	registry research, registry study, disease registry, registry-based cohort	pragmatic trial, real-world trial, effectiveness trial, PRECIS-2
関連	3	4
概要	Registry-based research uses systematically collected clinical data from patient registries—organized databases of patients with a specific disease or condition—to conduct observational studies. Registries began in the mid-20th century but have proliferated since the 2000s as electronic health records expanded and funding agencies recognized their value for real-world evidence generation. Registry studies provide large, diverse, representative populations without the cost of recruiting and following prospectively, enabling rapid generation of clinical evidence.	A pragmatic trial is designed to evaluate the real-world effectiveness of an intervention in typical clinical settings with diverse, representative patients, minimal exclusion criteria, and clinically relevant outcomes. Developed by Thorpe and colleagues (2009) and formalized via the PRECIS-2 framework (2015), pragmatic trials bridge the gap between explanatory efficacy trials (conducted in controlled research settings) and implementation science, answering the question 'Does this work in actual clinical practice?' rather than 'Can this work under ideal conditions?'