It is an ‘appendage’ to a randomised controlled clinical trial, usually of an unregistered medicine or intervention.
OLES stands for Open Label Extension Study (pharmaceutical research). Suggest new definition. This definition appears rarely and is found in the following Acronym Finder categories: 1  Science, medicine, engineering, etc.  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. Negative aspects of open-label extension studies revolve around their use as a marketing tool, as they build a market for the drug and generate pressure for subsidised access to the drug from consumers and their physicians. The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. Open-label: A term used to describe the situation when both the researcher and the participant in a research study know the treatment the participant is receiving. Open-label is the opposite of double-blind when neither the researcher nor the participant knows what treatment the participant is receiving.  Scientific merit. The validity of data from open label extension studies raises further questions. Open label extension studies are commonly used to assess long term tolerability of a new drug. However, a proportion of the participants eligible for the study will have already taken the study drug. However, it is not uncommon to find protocols of open label extension studies that specify the duration of the study as “until licence approved.” For some participants this could mean only a few weeks while for others it could be years, assuming the drug is ever licensed. As the name implies, an open-label extension study is an ‘appendage’ to a randomised controlled clinical trial, usually of an unregistered medicine or intervention. Often the drug is being studied under an investigational new drug (IND) licence or equivalent legislation. The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. There are factors that are predictive of whether open-label extension studies will be undertaken. Phase III studies in chronic diseases where inadequate response to conventional, available medications is a criterion for entry into the study are likely to be followed by an open-label extension study. The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. Knowledge about efficacy is less likely to be the motive for the open-label extension study. Terms such as ‘long-term safety’, ‘safety and tolerability’ and ‘safety and efficacy’, and ‘efficacy and tolerability’ are commonly employed. The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. 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. 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.
http://www.acronymfinder.com/Open-Label-Extension-Study-(pharmaceutical-research)-(OLES).html https://en.wikipedia.org/wiki/Open-label_trial http://link.springer.com/article/10.2165/00002018-200730020-00001/fulltext.html http://www.medicinenet.com/script/main/art.asp?articlekey=38693 http://www.bmj.com/content/331/7516/572 http://link.springer.com/article/10.2165/00002018-200730020-00001/fulltext.html http://link.springer.com/article/10.2165/00002018-200730020-00001/fulltext.html http://link.springer.com/article/10.2165/00002018-200730020-00001/fulltext.html https://en.wikipedia.org/wiki/Open-label_trial
open label extension study definition