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.
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.
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
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
Independent Data Safety Monitoring Board Recommends St.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
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 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.
The clinical trial, known as HPTN 052, was slated to end in 2015 but the findings are being released early as the result of a scheduled interim review of the study data by an independent data and safety monitoring board (DSMB).
FORBES: Could AIDS Disappear If Enough Patients Get Treated?
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
应用推荐