AstraZeneca's callout by data and safety review board a rarity

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A data and safety monitoring board formed by the National Institute for Allergy and Infectious Diseases made a rare move when it published a statement March 23 saying AstraZeneca's March 22 announcement that its COVID-19 vaccine was 79 percent effective was based on outdated data.

The incident has shone a light on the mostly hidden role independent data and safety review panels play in clinical trials.

The panels, which usually comprise medical experts and scientists, are meant to protect the study's scientific integrity and the participants' safety, Joseph Ross, MD, a professor of medicine and public health at the New Haven, Conn.-based Yale University School of Medicine told The Wall Street Journal.

The institute's data and safety monitoring boards have been evaluating data from COVID-19 vaccine studies to ensure the products aren't leading to safety risks. They also perform analyses to determine if products are overwhelmingly effective or ineffective, according to the Journal.

Usually, the board makes recommendations in private and its job ends once the FDA or a drugmaker receives its insight. When it came to AstraZeneca's March 22 announcement, the data and safety monitoring board decided it had to issue its statement and reveal the typically hidden inner processes of clinical trial reviews, the institute's director Anthony Fauci, MD, told the Journal.

“You have a U.S. government press release that’s out there based on a press release that the DSMB [data and safety monitoring board] has sharply criticized," he said. "So we felt it was absolutely necessary that we make a nonpejorative, nonaccusatory statement to say, 'Hey, you better get together with the DSMB and work this out.'"

 

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