Open-label trial

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

Clinical research and experimental design

Overview	Clinical trial Trial protocols Adaptive clinical trial Academic clinical trials Clinical study design

Controlled study (EBM I to II-1; A to B)	Randomized controlled trial Scientific experiment Blind experiment Open-label trial

Observational study (EBM II-2 to II-3; B to C)	Cross-sectional study vs. Longitudinal study, Ecological study Cohort study Retrospective Prospective Case-control study (Nested case-control study) Case series Case study Case report

Epidemiology/ methods	occurrence: Incidence (Cumulative incidence) Prevalence Point Period association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) relative (Relative risk, Odds ratio, Hazard ratio) other: Clinical endpoint Virulence Infectivity Mortality rate Morbidity Case fatality rate Specificity and sensitivity Likelihood-ratios Pre/post-test probability

Trial/test types	In vitro In vivo Animal testing Animal testing on non-human primates First-in-man study Multicenter trial Seeding trial Vaccine trial

Analysis of clinical trials	Risk–benefit ratio Systematic review Replication Meta-analysis

Interpretation of results	Selection bias Survivorship bias Correlation does not imply causation Null result

Category Glossary List of topics

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