data safety monitoring board


Also found in: Acronyms.

data safety monitoring board

, data and safety monitoring board,

DSMB

An independent group of scientists and concerned community members who oversee the interim findings of a research project to determine whether the research undertaken is proceeding without evidence of harm to the subjects enrolled in the study.
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Because risk:benefit issues may be complex for investigational agents, the use of a data safety monitoring board and early treatment stopping rules can be used in protocols to minimize risk to patients.
Safety endpoints will be reviewed by an Independent Data Safety Monitoring Board.
The safety and visual stability data from this part of the study resulted in the Data Safety Monitoring Board (DSMB) approving the transition to a commercially ready hRPC drug product formulation to be administered to patients with less retinal damage and consequently better visual potential.
M2 PHARMA-March 15, 2019-Soleno Therapeutics Touts Positive Outcome from Planned Data Safety Monitoring Board Review of Phase III DESTINY PWS Clinical Trial of DCCR in Prader-Willi Syndrome
After seeing these data in a pre-planned interim safety analysis, the Data Safety Monitoring Board stopped the study, saying that the intervention appeared dangerous for the younger babies, and no better than delayed cutting and clamping for the older group, Dr.
The independent Data Safety Monitoring Board notified the company that an interim analysis indicated that the predefined Bayesian futility rule used to determine the probability of the trial's success using the trial's primary endpoint of Day 28 overall response, had been passed.
Parenti reported serving on a data safety monitoring board for the National Institute of Allergy and Infectious Diseases and receiving research support from Merck, Pfizer, Cubist Pharmaceuticals, Janssen Pharmaceuticals, Insight, and the National Institutes of Health.
The Data Safety Monitoring Board (DSMB), an independent group of experts established to protect the participating infants' rights and needs during the Phase III trial, determined that the trial met the highest standards for ethics and patient care and complied with international standards for good clinical practices.
Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.
(Whitehouse Station NJ) said an independent data safety monitoring board has approved continuation of a big study meant to determine whether its blockbuster Vytorin cholesterol drug prevents heart attacks and stroke.
The Data Safety Monitoring Board (DSMB), an independent board monitoring the safety of PLX-PAD, will meet in approximately 30 days to determine dose escalation to the next dose level to be administered in this trial.