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.
- AKA: Open Label Study, Open Clinical Trial.
- Context:
- It is the opposite of a Blinded Clinical Trial.
- It usually adopted to compare treatment or interventions.
- Example(s):
- Counter-Example(s):
- See: Clinical Trial, Blinded Experiment, Prescription Drug, Anticoagulant, Symptom, Placebo, Randomized Controlled Trial.
References
2021
- (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.
- 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]
- ↑ "Open label study". National Cancer Institute, US National Institutes of Health. 2020. Retrieved 20 November 2020.
- ↑ 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.
- ↑ 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.
2021b
- (NCI/NIH, 2021) ⇒ https://www.cancer.gov/publications/dictionaries/cancer-terms/def/open-label-study Retrieved:2021-11-21.
- QUOTE: open label study
- A type of study in which both the health providers and the patients are aware of the drug or treatment being given.
- QUOTE: open label study
2021c
- (NIA/NIH, 2021) ⇒ https://www.nia.nih.gov/research/dgcg/nia-glossary-clinical-research-terms Retrieved:2021-11-21.
- QUOTE: Open-Label Trial – A clinical trial in which investigators and participants know which intervention is being administered.
2021d
- (HIV, 2021) ⇒ https://clinicalinfo.hiv.gov/en/glossary/open-label-trial Retrieved:2021-11-21.
- QUOTE: Open-Label Trial
- A type of clinical trial. In open-label trials, both the researchers and participants know which drug (or other intervention) is being given to participants.
- QUOTE: Open-Label Trial