An interim analysis conducted by the Data Safety Monitoring Board
found a highly statistically significant improvement in the primary endpoint, defined as "a decrease in the NAFLD activity score of at least two points with no worsening of fibrosis, as compared to placebo," Intercept said in a statement.
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.
Two Data Safety Monitoring Board
reviews of interim study data did not identify any safety concerns nor necessitate any change in the study design or conduct, and the study advanced until the targeted patient enrollment was achieved.
Debiopharm Group, Lausanne, Switzerland, a global independent biopharmaceutical development specialist focusing on serious medical conditions and particularly oncology, has announced that following a meeting of the independent Data Safety Monitoring Board
(DSMB), the company received a recommendation to continue its Phase II BRAINz study with Debio 9902 SR (sustained release) for the treatment of Alzheimer's disease (AD), without modification.
And finally, regarding the ongoing RECORD trial, "the independent data safety monitoring board
for RECORD recently reviewed an interim analysis of unblinded cardiovascular endpoints and confirmed that the trial should continue (manuscript in preparation)," he wrote.
Nissen said it would not be surprising if the data safety monitoring board
stopped the trial "because of a hazard in one or the other arm.
Shortly before approval, a clinical trial comparing FTC and d4T was stopped early by its Data Safety Monitoring Board
(a somewhat unusual occurrence) because the patients in that trial who were randomly assigned to FTC were clearly doing better than those randomly assigned to d4T.
Fremont, CA announced that an ad hoc independent Data Safety Monitoring Board
(DSMB) decided to close the company's comparative kidney transplant study early after an interim analysis revealed significantly fewer rejections in patients treated the Thymoglobulin [Anti-thymocyte globulin, (Rabbit)] versus Novartis' Pharmaceutical's, East Hanover, NJ, Simulect (basiliximab).
The small number of patients at each dose was not expected to fully characterize safety, efficacy, or pharmacodynamics, but rather to inform the data safety monitoring board
and Reata of the appropriate dose to select for future study.
a clinical-stage biopharmaceutical company focused on developing gene therapies for life-threatening rare diseases, announced today that the Data Safety Monitoring Board
(DSMB), an independent group of medical experts closely monitoring the clinical trial, has reviewed the initial safety data from the low dose cohort (n=3) in the Phase 1/2 clinical trial of ABO-102 (AAV-SGSH) enrolling at Nationwide Children's Hospital in Columbus, Ohio.
The decision was based on the results from a planned interim futility analysis by the independent Data Safety Monitoring Board
that indicated an insufficient improvement in lung function in the patients.