The Data Safety Monitoring Board for the APPROVe study recommended that the study be stopped for safety reasons.
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Like all major outcome studies, the IMPROVE-IT trial is being monitored by an independent data safety monitoring board (DSMB).
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One, Marvin Konstam of Tufts University, said he was on the data safety monitoring board for a study of Natrecor.
Biogen Idec and Elan intend to implement a PML safety monitoring system to try to catch early cases, should they occur.
He said that this risk will not be significantly reduced until there is a positive 12-month report from the safety monitoring committee.
An independent safety monitoring board decided that elevated liver enzymes in some patients raised questions about whether the drug was too toxic.
The lack of a data safety monitoring board is "sub-optimal, " says Steven Joffe, a bioethicist and researcher at the Dana Farber Cancer Center.
Data safety monitoring boards (DSMBs) are chartered to look at data from clinical trials as it comes into protect the safety of patient volunteers.
The trial was stopped early in July 2011 by the data and safety monitoring board when the benefits in the Mediterranean diet groups crossed a predetermined boundary.
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"Virtually every cell surveyed across the estate failed to pass our safety examination - there were numerous ligature points and health and safety monitoring was inconsistent, " the report said.
Because of the this change, and because the data and safety monitoring board reviewed the data multiple times over the course of the study, the threshold for statistical significance was lowered to 0.036.
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Independent Data Safety Monitoring Board Recommends St.
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Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent Data and Safety Monitoring Board (DSMB) has recommended that patient enrollment in the ongoing FAME II trial be stopped.
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In January 2003 the Microsoft SQL Server worm, known as Slammer, infected a private computer network at David-Besse nuclear power plant in Oak Harbor, Ohio, disabling a safety monitoring system for nearly five hours, says the Nuclear Regulatory Commission.
This study had neither a steering committee, as a group of experts who regularly convened to discuss the trial and its data, nor a data safety monitoring board (DSMB), which carefully watches study information to make sure patients are not harmed.
As a result of the positive interim analysis, the FAME II independent Data Safety Monitoring Board (DSMB) has recommended investigators stop patient enrollment in this trial as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) alone.
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Will the data safety-monitoring boards of these studies have to meet in order to make sure squamous cell patients are safe?
In mid-September a firm not affiliated with Arena found no safety problems after monitoring the hearts of people on lorcaserin for 6 months.
The firm provides emergency management, safety strategies and performance monitoring to the aviation industry.
Among its proposed powers will be the responsibility for monitoring the safety and standards of all food for human consumption.
He writes the data in the Peto analysis should only have been made available to the committees monitoring the safety of the patients in SHARP and IMPROVE-IT.
An independent committee charged with monitoring the safety and ethics of the study from a patient perspective told Lewis that the company might consider tracking the patients longer to see if those that got palifosfamide would live longer.
Ofsted inspectors said in April the service's monitoring of the safety of vulnerable children was inadequate.
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The Health and Safety executive confirmed it was monitoring the situation.
At a minimum, governments are supposed to lay down criteria for selecting storage sites and to set standards for monitoring, financial guarantees, safety and so on.
In both cases, video cameras combined with third-party monitoring and feedback reduced risk and increased safety.
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The FDA is reviewing current scientific studies on the safety of energy drinks, Ward said, and is monitoring new ingredients being added to these products.
Prof Pennington also criticised inspectors from Bridgend council for not assessing or monitoring the firm's management of food safety "as well as they could or should have done".
Scott Nova, executive director of the Worker Rights Consortium, a Washington-based nonprofit monitoring group, said labor-rights groups' calls for better safety measures at Bangladesh factories had been met with "vague promises" from retailers.
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