STAT+: For the first time, the FDA warns a trial investigator for failing to report study results
In a little noticed warning, the Food and Drug Administration threatened to fine the principal investigator of a clinical trial for failing to submit results as required by federal law, marking the first time the agency has widened its list of targets that could face penalties for such a violation.
Until now, the regulator had warned two different drug makers for failing to post study results to a federal database, ClinicalTrials.gov. Those moves came as a belated response to years of complaints that too many drug makers and universities do not follow requirements for reporting results, an issue that has riled countless researchers and transparency advocates.
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