data monitoring committee


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data monitoring committee

A group of experts who regularly review accumulating data from an ongoing clinical trial, advising the sponsor about safety of current (and future, if applicable) participants, and continuing validity and scientific merit of the trial. The committee can stop a trial if it finds toxicities in excess of that expected, or if the treatment is so clearly beneficial that FDA approval of the drug would be inevitable.
References in periodicals archive ?
The independent data monitoring committee based its recommendation on data from periodic data reviews, which suggested there was a low probability the study would achieve its primary endpoint based on results to date.
part of a planned interim analysis, an External Data Monitoring Committee (DMC)
We are currently evaluating the sequential administration of GVAX Pancreas and the Listeria-based CRS-207 in a randomized, controlled Phase 2 trial in patients with metastatic pancreatic cancer and the data monitoring committee will review the interim data this quarter.
The company is actively working with the Data Monitoring Committee, the Study Steering Committee and investigators with regard to the appropriate disposition of patients who have entered into the trial.
Late-stage testing of the drug, elesclomol, was halted in February after an independent data monitoring committee observed a higher number of deaths and other safety concerns.
The independent data monitoring committee (IDMC) charged with overseeing this study has on four occasions reviewed the mortality and all serious adverse event data and has four times recommended that the study continue without modification.
Evanston, IL, has received a recommendation from an independent data monitoring committee (IDMC) that the company continue its pivotal Phase 3 study of PolyHeme, the company's human hemoglobin-based blood substitute, without modification.
He also added that, per the Data Monitoring Committee, no changes need to be made to the protocol.
At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early.
The EF-14 trial Independent Data Monitoring Committee recommended terminating the trial early and allowing all control patients to receive Tumor Treating Fields
A late-stage trial of the drug, elesclomol, was suspended last month after an independent data monitoring committee observed higher number of deaths and other safety concerns.