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 ?
The confirmatory trial is planned to be conducted with the International Center for Health Outcomes Innovation Research at the Icahn School of Medicine at Mount Sinai in New York, in line with an existing Memorandum of Understanding.
The confirmatory trial is planned to be conducted with the International Center for Health Outcomes Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai in New York, in line with an existing Memorandum of Understanding.
To support full approval of tazemetostat for epithelioid sarcoma, Epizyme will initiate a global confirmatory trial. The primary efficacy endpoint will be progression-free survival, and secondary efficacy endpoints will include overall survival, disease control rate, overall response rate and duration of response.
The company said it will not start its confirmatory trial without obtaining the US FDA's concurrence on the trial design.
The company will present the concordant results from the prior two trials, together with the plan for a confirmatory trial powered for the primary endpoint of reduction in GI bleeding.
Monika bagged a silver medal at the Inter-State championships with the timing of 4:12.44, while at the confirmatory trial held in Bhutan on 15 August 2018, she clocked 4:41.06.
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.
A second, confirmatory trial evaluated tesetaxel as 1st-line chemotherapy for locally advanced or metastatic HER2-negative breast cancer (as described above).
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.