Drug companies failed to submit 11% of status reports for clinical trials they were required or had agreed to conduct when their medicines were initially approved, according to a new analysis that tracked more than 700 reports during the 12-month period ending September 2020. Another 13% of those follow-up trials were submitted late.
Meanwhile, a quarter of nearly 1,600 of these so-called post-marketing requirements and commitments were not progressing on schedule, which means the follow-up trials were either delayed or ended. And three dozen trials that were required as a condition for receiving accelerated approval were also delayed or ended, the U.S. Food and Drug Administration report found.