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 difference in the responsibilities of data monitoring committees and institutional review boards
The ALSYMPCA Independent Data Monitoring Committee (IDMC) issued the recommendation after a pre-planned interim analysis.
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.
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.
Additionally, based on an interim analysis for overall survival, the Data Monitoring Committee recommended that the study continue.
After examining data, the study's Data Monitoring Committee of independent experts recommended that the company continue with its study as planned.
After an early efficacy review by the Independent Data Monitoring Committee (IDMC), AstraZeneca has decided to stop the study as it is deemed unlikely to benefit patients.
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.
This decision follows an interim analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC) and review of those data by Gilead, which did not show evidence of a treatment benefit in the group of patients randomized to receive ambrisentan.
The second, and final, interim futility analysis was conducted by RESULT's Data Monitoring Committee which is comprised of experts appointed by the Cystic Fibrosis Foundation's Therapeutics Development Network.