手法を比較

	実用的な第III相臨床試験	クラスターランダム化比較試験	ランダム化比較試験 (RCT)
分野	疫学	臨床研究	実験計画法
系統	Process / pipeline	Process / pipeline	Hypothesis test
提唱年	1967 (Schwartz & Lellouch); formalized further in 2000s–2010s	1999-2000	1948
提唱者	Schwartz & Lellouch (distinction between pragmatic and explanatory trials)	Campbell, Grimshaw, Elbourne et al.	James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)
種類	Randomized controlled trial design	Research Design	Interventional comparative study
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.	Campbell, M. K., Grimshaw, J. M., & Elbourne, D. R. (2000). Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported. BMC Medical Research Methodology, 4, 30.	Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332.
別名	pragmatic RCT, effectiveness trial, real-world RCT, pragmatic trial	CRT, cluster RCT, cluster trial, group randomization	RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı
関連	2	3	7
概要	A pragmatic phase III clinical trial is a large-scale randomized study designed to evaluate whether an intervention works under the conditions of everyday clinical practice rather than the tightly controlled environment of an explanatory efficacy trial. It recruits a broad, representative patient population, allows flexibility in treatment delivery, and measures outcomes that matter to patients and health systems, generating evidence directly applicable to real-world treatment decisions.	A cluster randomized trial (CRT) randomizes intact groups—schools, clinics, villages, or hospital wards—rather than individuals. Developed by Campbell, Grimshaw, and colleagues in the late 1990s to address real-world settings where intervention delivery or contamination occurs at the group level, CRTs are now standard for evaluating population-level, community-based, and policy interventions.	A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010).