An open-label trial or open trial is a type of clinical trial in which both the researchers and participants know which treatment is being administered.  This contrasts with single blind and double blind experimental designs, where participants are not aware of what treatment they are receiving (researchers are also unaware in a double blind trial).
Open-label trials may be appropriate for comparing two very similar treatments to determine which is most effective. An open-label trial may be unavoidable under some circumstances, such as comparing the effectiveness of a medication to intensive physical therapy sessions.
An open-label trial may still be randomized. Open-label trials may also be uncontrolled, with all participants receiving the same treatment.
Biomedical research: Clinical study design / Design of experiments Overview Controlled study
(EBM I to II-1; A to B)
(EBM II-2 to II-3; B to C)
occurrence: Incidence (Cumulative incidence) · Prevalence (Point prevalence, Period prevalence)
association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) · relative (Relative risk, Odds ratio, Hazard ratio)
other: Virulence · Infectivity · Mortality rate · Morbidity · Case fatality · Specificity and sensitivity · Likelihood-ratios · Pre/post-test probability
Trial/test types Analysis of clinical trials
Interpretation of results
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