AstraZeneca COVID-19 Vaccine Data Highlight Safety Monitoring Boards’ Role in Clinical Trials

Confusion over AstraZeneca’s COVID-19 vaccine trial data recently arose when the data and safety monitoring boards (DSMBs) overseeing the trial took a public stand to question the accuracy of the efficacy that the drug manufacturer cited in a press release. The dispute exposes the role that these typically nonpublic entities play in overseeing clinical pharmaceutical trials.

These independent expert panels, composed of medical experts biostatisticians, clinicians, and epidemiologists, are responsible for maintaining the safety and scientific integrity of clinical trials. While their responsibilities may vary from study to study, they generally evaluate data from ongoing trials to ensure that a treatment or vaccine does not pose unexpected safety risks. If such risks arise, or if a product is so effective or ineffective that it would be unethical to continue enrolling patients, the DSMBs can recommend halting a study early.

“Almost no DSMB or ethical oversight committee has any responsibility for how information is reported to the public,” said Joseph Ross, MD, MHS, professor of medicine and of public health at Yale University School of Medicine. “[DSMBs typically do simple analyses and are] not really thinking big picture about interpreting the results.”

The DSMB overseeing the AstraZeneca vaccine trial was formed by the National Institute of Allergy and Infectious Diseases (NIAID), which also helped fund the study.

On March 22, NIAID issued a press release based on the pharmaceutical company’s statement on the vaccine’s effectiveness in clinical trials. Later that day, NIAID officials received a letter from the DSMB criticizing AstraZeneca’s trial disclosure for not including the most recent and accurate data. In response, U.S. government officials decided to issue an unusual statement acknowledging the dispute, according to NIAID Director Anthony Fauci, MD. “You have a U.S. government press release that’s out there based on a press release that the DSMB has sharply criticized,” Dr. Fauci 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.’”

The pushback from NIAID and the DSMB reveals aspects of the clinical trials process that are usually kept private. It also is the latest in a series of tense interactions between AstraZeneca and regulators in the U.S. and Europe.

Dr. Fauci added that the vaccine is safe and effective, and once AstraZeneca includes the more recent data in its application, the reported 79% effectiveness is unlikely to change drastically. “That’s the ironic part about it,” he said. “I mean, this is kind of unfortunate that this happened because at the end of the day, it’s still a good vaccine.”

Source: The Wall Street Journal, March 23, 2021.