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.

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Role of statisticians and the interim analyses they conduct in data monitoring committees

Establishing a data monitoring committee for clinical trials

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.

Northfield Labs receives go ahead from independent committee to proceed with Phase 3 PolyHeme study

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.

NuCana's ACELARATE futility does not change view, says H.C. Wainwright

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

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 reveals data from the phase three Stellar-four study of selonsertib

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.

-AstraZeneca to halt phase III study with zibotentan

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.

Synta Pharmaceuticals Inc

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.

NuCana announces suspension of enrollment in Phase III ACELARATE study

Tocagen announced in August that the Toca 5 study would continue without modification after an independent data monitoring committee completed the first interim analysis.

Tocagen completes patient enrolment for brain cancer trial

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.