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.
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Stergiou, Biovest's Vice President, Product Development, Medical Affairs & Clinical Research, "This Phase 2 data, combined with our analysis of the blinded Phase 3 results, and the DMC's recommendation to unblind, gives us a high level of confidence in unblinding the current Phase 3 study, both for efficacy and safety.
The Company expects to have access to additional sources of capital following the unblinding of the SinuNase and BiovaxID Phase 3 clinical trials data, including through potential corporate collaborations and licensing agreements.
We now look forward to completion of the inoculations and the unblinding of safety and immunogenicity results for the entire trial.
Accordingly, Accentia reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect.
Accordingly, Biovest reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect.
The unblinding conference for the Phase I clinical data in the adult group was held on the afternoon of March 9, 2011.
Forward-looking statements include, among others, our expectations on the timing of unblinding of the FREEDOM-M study and our belief that the FREEDOM-M study unblinding will bring us closer to the goal of achieving an approved oral prostacyclin therapy for PAH.
The clinical data unblinding conference was held in Beijing on the afternoon of August 17, 2009.
The results of the trial will be announced after unblinding the data in the first quarter of 2008.
Catalyst expects to complete the analyses during the third quarter after fully unblinding the trial data and will then formulate future development plans.
Study investigators are being advised this week to provide this information to the volunteers; volunteers will receive additional information about the unblinding process directly from study sites.
Since the unblinding of our randomized study in front-line MDS, we have learned that the combination of Pracinostat and azacitidine resulted in a high rate of discontinuations due to adverse events compared to azacitidine alone.