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Pragmatisk Fase IV-studie×Dosis-respons-analyse×
FagområdeEpidemiologiEpidemiologi
FamilieProcess / pipelineProcess / pipeline
Oprindelsesår1967 (pragmatic concept); 2000s (pragmatic Phase IV formalized)Conceptual roots 16th century; modern epidemiological application mid-20th century
OphavspersonSchwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); PRECIS framework by Thorpe et al. (2009)Paracelsus (conceptual foundation); formalized by John Snow and later Bradford Hill
TypeObservational / interventional hybrid study designQuantitative analytical method
Oprindelig kildeThorpe, 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. DOI ↗Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
Aliasserpragmatic post-marketing study, real-world phase IV trial, pragmatic pharmacovigilance study, pragmatic post-approval studyexposure-response analysis, concentration-response modeling, dose-response modeling, DRA
Relaterede54
ResuméA 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.Dose-response analysis quantifies the relationship between the magnitude of an exposure (the dose) and the probability or rate of an outcome (the response). It is a core analytical strategy in epidemiology and toxicology, providing evidence that increasing exposure systematically increases — or decreases — the risk of disease. A demonstrated dose-response gradient is one of Bradford Hill's classic criteria supporting causal inference.
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ScholarGateSammenlign metoder: Pragmatic phase IV study · Dose-Response Analysis. Hentet 2026-06-17 fra https://scholargate.app/da/compare