Double-Blinded Clinical Trial

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A Double-Blinded Clinical Trial is a Blinded Clinical Trial in which neither the participants nor researchers know which treatment (or intervention) a specific participant is receiving.



References

2021a

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Blinded_experiment#Terminology Retrieved:2021-11-21.
    • In medical research, the terms single-blind, double-blind and triple-blind are commonly used to describe blinding. These terms describe experiments in which (respectively) one, two, or three parties are blinded to some information. Most often, single-blind studies blind patients to their treatment allocation, double-blind studies blind both patients and researchers to treatment allocations, and triple-blinded studies blind patients, researcher, and some other third party (such as a monitoring committee) to treatment allocations. However, the meaning of these terms can vary from study to study.[1]

      CONSORT guidelines state that these terms should no longer be used because they are ambiguous. For instance, "double-blind" could mean that the data analysts and patients were blinded; or the patients and outcome assessors were blinded; or the patients and people offering the intervention were blinded, etc. The terms also fail to convey the information that was masked and the amount of unblinding that occurred. It is not sufficient to specify the number of parties that have been blinded. To describe an experiment's blinding, it is necessary to report who has been blinded to what information, and how well each blind succeeded.

  1. Schulz KF, Chalmers I, Altman DG (February 2002). "The landscape and lexicon of blinding in randomized trials". Annals of Internal Medicine. 136 (3): 254–9. doi:10.7326/0003-4819-136-3-200202050-00022. PMID 11827510. S2CID 34932997.

2021b

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-21.
    • QUOTE: Blind
      • A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. (NLM)
      • A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the subject(s) being unaware, and double blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH E6)

2021c

2021d

2021e

2012