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.
The lack of a data safety monitoring board is "sub-optimal, " says Steven Joffe, a bioethicist and researcher at the Dana Farber Cancer Center.
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
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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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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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
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