- Open-label trial
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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.[1] [2] 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.
References
Biomedical research: Clinical study design / Design of experiments Overview Controlled study
(EBM I to II-1; A to B)Randomized controlled trial (Blind experiment, Open-label trial)
Observational study
(EBM II-2 to II-3; B to C)Epidemiology/
methodsoccurrence: 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 probabilityTrial/test types Analysis of clinical trials Risk–benefit analysis
Interpretation of results Categories:
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