Building an Effective Data Safety Monitoring Board (DSMB): A Sponsor’s Quick-Start Guide

In July 2002, the US Women’s Health Initiative stopped its estrogen plus progestin trial about three years early. The trial had enrolled 16,608 women. Its data safety monitoring board had found that health risks exceeded the benefits, and its recommendation was unanimous.  That call protected thousands of women. It worked because the board, its stopping […]