Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Defined term · Trial design and conduct

Open-label extension

A period following the randomised phase in which all participants receive active treatment. Reports persistence and long-term tolerability; cannot re-establish comparative efficacy.

Document identifier
CEI-GT-064
Series
Defined term
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Open-label extension

§1.1Also known as

OLE

§1.2Category

Trial design and conduct — Terms describing how a clinical study is constructed and run.

§1.3Related terms

  • Open-label — A design in which assignment is known to participants and investigators. Objective endpoint measurement limits but does not eliminate the resulting risk, because…
Compound Evidence Institute · CEI-GT-064 · https://compoundevidence.com/glossary/open-label-extension/ · retrieved 30 July 2026
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