What does DSMB stand for?

As previously reported, vaccinations were discontinued on 11 July 2008 based on the recommendation of the study's independent Data Safety Monitoring Board (DSMB), which concluded that the study would not meet its predefined primary endpoint of an improvement in overall survival.

To date, there have been nine positive safety reviews from the Data Safety Monitoring Board (DSMB).

The BART data safety monitoring board (DSMB) notified the trials' executive committee two weeks ago that an interim analysis indicated that Trasylol treatment appeared to reduce bleeding, but an increase in all-cause mortality almost reached conventional statistical significance for 30-day mortality for patients in the Trasylol treatment arm compared to patients who received either aminocaproic acid or tranexamic acid.

A company is not necessarily required to halt a trial if a data safety monitoring board recommends it, experts said.

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.

Also, device accountability records were found to be incomplete and copies of data safety monitoring board reports were found to be missing.

The CDC is addressing concerns about adverse reactions to the smallpox vaccine by formation of a panel of oversight experts called the Data Safety Monitoring Board.

The CDC is addressing concerns about adverse reactions to the smallpox vaccine by formation of a panel of oversight experts called the Data Safety Monitoring Board.