Research misconduct found by FDA inspections of clinical trials is rarely reported in journal studies

Apparent research misconduct identified during inspections of clinical trial sites by the US Food and Drug Administration (FDA) is rarely mentioned in subsequently published journal articles about the research, says a study that has highlighted a gap in the transparency of clinical trial reporting.

The review1 identified 57 published clinical trials for which an FDA inspection of one of the trial sites had found significant evidence of research misconduct, including falsification or the submission of false information, problems with adverse event reporting, or …