The dispute over AstraZeneca’s Covid-19 vaccine trial has exposed the crucial role played by independent expert panels in behind-the-scenes oversight of clinical pharmaceutical trials.
The panels, called data and safety monitoring boards, are typically composed of medical experts and scientists such as biostaticians, clinicians and epidemiologists. They are tasked with safeguarding the safety of study volunteers and the scientific integrity of the studies, said Joseph Ross, professor of medicine and of public health at Yale University School of Medicine.
The responsibilities of DSMBs can vary from study to study, but in general they evaluate data from ongoing studies at prespecified points in time to ensure that a drug or vaccine isn’t causing unexpected safety risks.
If safety concerns do arise, the DSMBs can recommend that the study be stopped early.
The boards also conduct occasional analyses to see if the product appears so overwhelmingly effective or ineffective that the study should be halted because it would be unethical to continue enrolling patients.
