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Open-label trial

From Wikipedia, the free encyclopedia
Clinical trial where the treatment isn't hidden

Anopen-label trial, oropen trial, is a type ofclinical trial in which information is not withheld from trial participants.[1] In particular, both the researchers and participants know which treatment is being administered.[1] This contrasts with adouble-blinded trial, where information is withheld both from the researchers and the participants to reduce bias.[2][3]

Open-label trials may be appropriate for comparing two similar treatments to determine which is most effective, such as a comparison of differentprescriptionanticoagulants,[4] or possible relief fromsymptoms of some disorders when aplacebo is given.[5]

An open-label trial may still berandomized. Open-label trials may also be uncontrolled (without aplacebo group), with all participants receiving the same treatment.[4]

References

[edit]
  1. ^ab"Open label study". National Cancer Institute, US National Institutes of Health. 2020. Retrieved20 November 2020.
  2. ^"Double-blind (trial)". Merriam-Webster Medical Dictionary. 2020. Retrieved20 November 2020.
  3. ^"Double-blind study". HIV.gov, Office of AIDS Research, US National Institutes of Health. 2020. Retrieved20 November 2020.
  4. ^abBeyer-Westendorf, J.; Buller, H. (2011)."External and internal validity of open label or double-blind trials in oral anticoagulation: better, worse or just different?".Journal of Thrombosis and Haemostasis.9 (11):2153–2158.doi:10.1111/j.1538-7836.2011.04507.x.ISSN 1538-7933.PMID 21920015.
  5. ^Ballou, Sarah; Kaptchuk, Ted J.; Hirsch, William; Nee, Judy; Iturrino, Johanna; Hall, Kathryn T.; Kelley, John M.; Cheng, Vivian; Kirsch, Irving; Jacobson, Eric; Conboy, Lisa; Lembo, Anthony; Davis, Roger B. (25 May 2017)."Open versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial".Trials.18 (1): 234.doi:10.1186/s13063-017-1964-x.ISSN 1745-6215.PMC 5445390.PMID 28545508.
Overview
Controlled study
(EBM I to II-1)
Observational study
(EBM II-2 to II-3)
Measures
Occurrence
Association
Population impact
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Trial/test types
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Interpretation of results
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