open-label extension
A study phase where all participants receive active treatment after completing a blinded trial.
Full Definition
An open-label extension (OLE) is a study design element that allows participants who complete a randomized controlled trial to continue receiving active treatment in an unblinded fashion for an extended period. During the OLE phase, both participants and investigators know which treatment is being administered. OLEs serve multiple purposes in psychiatric research: they provide long-term safety and tolerability data, allow assessment of sustained efficacy, offer continued treatment access for participants who benefited from the study drug, and can help with patient recruitment by providing longer-term treatment options. OLE data, while valuable for safety assessment, has limitations for efficacy evaluation due to the lack of a control group and potential selection bias.
Usage
Usage note: Can be abbreviated as OLE after first use. Emphasize the unblinded nature when relevant.
In Context
- "Patients completing the 8-week double-blind phase were eligible to enter the 44-week open-label extension." — study design description
- "Long-term safety data from the open-label extension supported the drug's favorable benefit-risk profile." — safety conclusions