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 ?
Role of statisticians and the interim analyses they conduct in data monitoring committees
Northfield Laboratories, Inc., 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.
Wainwright analyst Raghuram Selvaraju said NuCana's announcement that the Independent Safety and Data Monitoring Committee concluded that Acelarin monotherapy was unlikely to meet the primary objective of the ACELARATE trial does not change his enthusiastic view about Acelarin.
M2 PHARMA-April 3, 2019-CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study
The company will work with the Data Monitoring Committee and investigators to complete the Stellar-four study without compromising on the interests of each patient.
Gilead Sciences' Phase III Study evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) will be unblinded early following the recommendation by an independent Data Monitoring Committee (DMC) based on a interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS).
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.
NuCana reported that it has been informed by the Clatterbridge Cancer Centre, the sponsor of the ongoing Phase III ACELARATE study, that the enrollment of new patients has been suspended on the advice of the Independent Safety and Data Monitoring Committee following completion of a prespecified futility analysis.
Tocagen announced in August that the Toca 5 study would continue without modification after an independent data monitoring committee completed the first interim analysis.
Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), treatment with KEYTRUDA in combination with chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone.
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.