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.
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Such statements include, but are not limited to, statements about BioSante's plans and intentions with respect to the two new LibiGel Phase III efficacy trials and the timing of certain milestones in connection therewith, the timing of the next review of the LibiGel Phase III safety study by the independent Data Monitoring Committee and other statements identified by words such as "intends," "anticipates," "will," "continue," "could," "believes," "expects," "targets," "may," "estimates," other words of similar meaning, derivations of such words and the use of future dates.
Safety data from Part 1 of the trial will be evaluated by an independent data monitoring committee who will determine if it is safe to begin Part 2.
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.
In October, 2010, an independent data monitoring committee recommended the early termination of the Phase III, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.
The RESONATE trial was halted early in January 2014 based on the recommendation of an Independent Data Monitoring Committee (IDMC) at the formal pre-planned interim analysis, which found IMBRUVICA was associated with a significant improvement in progression-free survival (the primary endpoint of the study) versus ofatumumab, and in overall survival (a key secondary endpoint of the trial).
Independent Data Monitoring Committee review determines that both Phase III Special Protocol Assessment pivotal trials overwhelmingly exceeded the pre-established efficacy stopping rule of p <0.
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.
The Independent Data Monitoring Committee (IDMC) indicated that its review of the current safety information revealed no specific safety concern and the data is in line with the known safety information for the MAGE-A3 cancer immunotherapeutic.
The decision was made after a regularly scheduled interim review of data by the trial's independent data monitoring committee determined that the trial could not demonstrate efficacy even if it continued to its originally-planned conclusion.
The Independent Data Monitoring Committee (IDMC) indicated that its review of the current safety information raised no specific concern for the continuation of the trial and is in line with the known safety information for the MAGE-A3 cancer immunotherapeutic.
Independent Data Monitoring Committee (DMC) Recommends That the BELIEF Study Continue According to Protocol Until 100 Evaluable Patients Enrolled
Janssen Research & Development, LLC announced today that following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, it has halted early a Phase 3 clinical study of paliperidone palmitate 3-month formulation, an investigational treatment for symptoms of schizophrenia in adults.
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