The Data Safety Monitoring Board for the APPROVe study recommended that the study be stopped for safety reasons.
FORBES: Vioxx and Diclofenac: Why Are Two Heart Risky Pain Drugs Viewed Differently?
Like all major outcome studies, the IMPROVE-IT trial is being monitored by an independent data safety monitoring board (DSMB).
FORBES: Cholesterol Drug Heart Study Continues, But Will Merck's Vytorin Really IMPROVE-IT?
One, Marvin Konstam of Tufts University, said he was on the data safety monitoring board for a study of Natrecor.
Will the data safety-monitoring boards of these studies have to meet in order to make sure squamous cell patients are safe?
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.
Like all advanced Drobo innovations, this new data protection feature is fully automated, so all users can enjoy the data safety benefits traditionally reserved for large enterprise customers, and previously unattainable in this price category.
ENGADGET: Drobo's new 5N is a speedy $600 NAS for when you need files, stat
Independent Data Safety Monitoring Board Recommends St.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
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.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
Last month, OSTP and the Department of Transportation co-hosted a Safety Data Jam at the Eisenhower Executive Office Building that brought together 40 leaders from technology, public safety, and government communities to discuss public safety challenges and to brainstorm creative new solutions that leverage open government safety data.
WHITEHOUSE: Safety Data Jam connects Tech Innovators with Public Safety Officers | The White House
Are you building apps that empower people to make informed decisions about their safety and the safety of others using data from Safety.
WHITEHOUSE: Administration Safety Data Initiative Challenges App Developers | The White House
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.
FORBES: NIH Trial Gives Surprising Boost To Chelation Therapy
In September, the Safety Data Initiative will host a Safety Datapalooza at which a cross-section of the most innovative safety applications submitted will be highlighted.
WHITEHOUSE: Administration Safety Data Initiative Challenges App Developers | The White House
The FDA defends its own use of the data for safety surveillance and it issues frequent MedWatch alerts on potential problems.
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.
FORBES: Large Trial Shows Cardiovascular Benefits Of Mediterranean Diet
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.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
This showed that GSK had an honest belief that these preliminary data on safety were reassuring as the company was considering whether to submit new (more positive) safety wording for inclusion in the product's label to regulators for approval.
Certainly one would agree that the quantity and the quality of the safety data and the involvement of the FDA in the planning of the LibiGel safety study all are positive indications for LibiGel.
This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data.
Over the last 20 years or so it has expanded its mission from reducing costs in hospital supply chains to also aggregating hospital data for information on quality, safety and lab data.
But the panel dashed the company's hopes, saying there wasn't enough long-term safety data.
The company will also have to submit new safety data emerging from ongoing trials.
Safety data incorporated into guidelines for adult care are also being taken into account.
WSJ: Children's Hospitals Make Room for Mom, Dad and Diversions
BNFL's faked safety data were not redundant, nor simply due to a few bored workers.
That remains his position, but it is now dependent on the results of a review of safety data.
Full safety data, including information on psychiatric and cardiovascular adverse events, will be presented at a later date.
And come up totally clean on the review of the rat safety data.
Schering-Plough is expected to present new safety data to address this on Tuesday.
应用推荐