confirmatory trial

confirmatory trial

A Phase-3 clinical trial during which the previously revealed actions of a therapeutic intervention are confirmed.
References in periodicals archive ?
In 2010, Pfizer voluntarily withdrew it in the US after a confirmatory trial failed to show clinical benefit and there was a higher rate of fatal toxicity compared to chemotherapy.
It is the first comprehensive cardiac care panel using a precision personalized medicine approach and is in the process of a confirmatory trial to present to the FDA.
The author covers the organization of a safety monitoring program for a confirmatory trial, clinical issues, bias and pitfalls to avoid, data monitoring committee decisions, statistical issues, and a wide variety of other related subjects.
Based on these results, repeat dosing at 8 to 12 weeks and a larger confirmatory trial are warranted, the investigators said.
However, a former MP alleged, in a letter to a Cabinet minister, that a third company with an Israeli partner was allowed to take part in a confirmatory trial.
It was also felt that regulatory bodies could consider positive results from VOICE as a possible confirmatory trial of CAPRISA 004.
Teva and the FDA will work together to determine the best design for a confirmatory trial with Laquinimod, Yanai added.
ADPnews) - May 4, 2011 - Austrian vaccine maker Intercell AG (WBAG:ICLL) announced today the start of a confirmatory trial in the field of pandemic influenza for the investigation of its adjuvant patch -- Vaccine Enhancement Patch (VEP).
We have begun to accelerate the efforts to conduct a Phase III Confirmatory Trial for Cintredekin Besudotox, IL-13-PE38, for the Treatment of Recurrent Glioblastoma Multiforme.
Within the next six weeks, Ortec expects to complete the confirmatory trial designed to confirm the superiority of cryopreserved OrCel in the treatment of difficult-to-heal venous leg ulcers in comparison to the standard of care therapy.
A second, confirmatory trial evaluated tesetaxel as 1st-line chemotherapy for locally advanced or metastatic HER2-negative breast cancer (as described above).
However, at a recent meeting the FDA recommended that the confirmatory trial isolate the effect of Ceplene from the effect of IL-2 by comparing Ceplene in combination with IL-2 to IL-2 as monotherapy, Epicept said today.