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Adaptív randomizált klinikai vizsgálat×Pragmatikus randomizált klinikai vizsgálat×
TudományterületEpidemiológiaEpidemiológia
MódszercsaládProcess / pipelineProcess / pipeline
Keletkezés éveLate 1990s–2000s (widespread adoption post-2010)1967
MegalkotóDonald Berry and colleagues; formalized by FDA guidance in 2010 and 2019Daniel Schwartz & Joseph Lellouch
TípusExperimental clinical trial designInterventional study design
AlapműBerry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗
Alternatív nevekadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trialpragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
Kapcsolódó66
ÖsszefoglalóAn adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.A pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009.
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ScholarGateMódszerek összehasonlítása: Adaptive Randomized Clinical Trial · Pragmatic randomized clinical trial. Letöltve 2026-06-19, forrás: https://scholargate.app/hu/compare