Open-Label Clinical Trial

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An Open-Label Clinical Trial is a Clinical Trial in which both the participants and researchers know which treatment (or intervention) a specific participant is receiving.



References

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  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Open-label_trial Retrieved:2021-11-21.
    • An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants.[1] In particular, both the researchers and participants know which treatment is being administered. This contrasts with a double-blinded trial, where information is withheld both from the researchers and the participants to reduce bias. Open-label trials may be appropriate for comparing two similar treatments to determine which is most effective, such as a comparison of different prescription anticoagulants[2] or possible relief from symptoms of some disorders when a placebo is given.[3]

      An open-label trial may still be randomized. Open-label trials may also be uncontrolled (without a placebo group), with all participants receiving the same treatment.

  1. "Open label study". National Cancer Institute, US National Institutes of Health. 2020. Retrieved 20 November 2020.
  2. Beyer-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.
  3. 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-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial". Trials. 18 (1). doi:10.1186/s13063-017-1964-x. ISSN 1745-6215.

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