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	Pragmatisk Fas III Klinisk Prövning	Kluster randomiserad studie
Ämnesområde	Epidemiologi	Klinisk forskning
Familj	Process / pipeline	Process / pipeline
Ursprungsår	1967 (Schwartz & Lellouch); formalized further in 2000s–2010s	1999-2000
Upphovsperson	Schwartz & Lellouch (distinction between pragmatic and explanatory trials)	Campbell, Grimshaw, Elbourne et al.
Typ	Randomized controlled trial design	Research Design
Ursprungskälla	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.
Alias	pragmatic RCT, effectiveness trial, real-world RCT, pragmatic trial	CRT, cluster RCT, cluster trial, group randomization
Närliggande	2	3
Sammanfattning	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.