STAT+: One in four pharma status reports on follow-up trials are late or aren’t filed

“It’s one thing not to start a trial... But it’s another thing not to send in status reports. That’s a complete failure of management."

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.

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