unblinding


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unblinding

A term of art used in clinical trials for the identification of the treatment code of a subject/patient or grouped results in studies where the treatment assignment was unknown to the subject and investigators.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
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Unlike the treatment with EGb, up to 90% of the patients given the Ch E inhibitors developed nausea and vomiting, so there is a suspicion that methodological reasons in the sense of an "unblinding" of the treatment groups caused the apparent superiority in the intensity of the effect.
On unblinding the dosing information, we observed that the adaptive Bayesian approach was able to identify 8 of the 20 patients during the drug-administration period for a drug without prior documentation of renal impairment.
Dobbs of the Institute of Psychiatry, King's College London, reported follow-up to a mean of 468 days after unblinding. The primary outcome measure was time trend in mean stride length at free-walking speed.
In placebo-controlled studies with synthetic antidepressants, experienced physicians can recognise the tell-tale side effects of these drugs, such as dry mouth, visual disturbances and dizziness, which arise in about 20% to 50% of patients and thus a degree of unblinding may occur.
Unblinding of the virtual results during the optical screening led to detection of 36 additional polyps measuring 6 mm or larger, 21 of which were adenomatous.
(11) Primary pairwise comparisons were amended in the statistical analysis plan before data unblinding to compare placebo with 10 and 20 mg valdecoxib, but not with the 5-mg dose.
While the new rule does not mention unblinding, FDA has inserted its opinion regarding this aspect of clinical trials conduct into the guidance document.
The remaining two genotypes (*1/*5 and *1/*4) were eventually run and correctly identified, but not before the unblinding of the DNA samples; thus, they were omitted from the comparison.
Because of a low incidence of influenza infection (38/1559, 2.4%), the investigators combined the data before unblinding. Subjects were started on oseltamivir or placebo following an increase in influenzavirus activity at the clinical site.
Since patients had their dosage titrated according to side effects there is the potential for bias from unblinding to occur.
Although our study was formally double-blinded, we have evidence that unblinding was common.
The study remains blinded and unblinding and analysis of the data will not take place until patients have completed all protocol periods and the database has been locked.