independent data monitoring committee


Also found in: Acronyms.

independent data monitoring committee

In a clinical trial, a committee established by the drug sponsor to periodically assess the progress of the trial, safety data and critical efficacy variables, and to recommend to the sponsor whether to continue, modify or terminate the trial.
References in periodicals archive ?
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.
The ninth unblinded review of safety data from the LibiGel Phase III safety study by the independent Data Monitoring Committee (DMC) is expected to occur during the third quarter 2012.
An independent Data Monitoring Committee (DMC) will conduct an interim safety data review from the first cohort after patients have completed three months of dosing.
It was expected to last until 2018, but results were so impressive that the Independent Data Monitoring Committee recommended that the trial finish early.
Safety data from all six subjects was reviewed by an independent Data Monitoring Committee and approval was provided to commence with Cohort 2.
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.
In October, 2010, an independent data monitoring committee recommended the early termination of the Phase III, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.
Faron Pharmaceuticals Ltd ("Faron"), the clinical stage biopharmaceutical company, announces that it has received the first recommendation from the Independent Data Monitoring Committee (IDMC) of the INFORAAA study to continue the trial as planned using Faron's wholly owned lead product, Traumakine.
The independent data monitoring committee has recommended halting the trial as it indicated comparable efficacy between the rivaroxaban and aspirin arms and little chance of demonstrating overall benefit after the completion of the study.
According to the company, it will continue its CR-AIR-008 trial, treating patients with a single dose of ATIR101 according to the recommendation of the Independent Data Monitoring Committee (IDMC) and according to the clinical protocol.
Bayer Healthcare (Berkeley CA), a unit of Germany's Bayer AG, said it stopped a late-stage trial of Nexavar in patients with non-small cell lung cancer, after an independent data monitoring committee said it would not meet the main goal of improved overall survival.
SEOUL, South Korea & OSLO, Norway -- KAEL-GemVax, a leading oncology biopharmaceutical company, today announced that it had been officially notified by the independent Data Monitoring Committee that over 1000 patients have been enrolled in the TeloVac Study, making it the world's largest ever pancreatic cancer vaccine trial.
Full browser ?