STAT+: In a rare move, FDA threatens to fine a company for failing to report clinical trial results
In a rare move, the FDA has threatened to fine a company for failing to report clinical trial results.
For only the fifth time, the Food and Drug Administration recently threatened to fine a company or clinical trial investigator for failing to post study results on a federal government database. And transparency advocates say this is the latest proof that the agency needs to step up enforcement.
In a July 19 letter, the FDA warned Light Sciences Oncology about its failure to post study results about a prostate treatment to the database, ClinicalTrials.gov. Its trial was completed in 2017, but the company missed a deadline to seek a reporting extension. After receiving the FDA letter, Light Sciences posted results on Aug. 2, although outstanding issues remain with its submission.
A U.S. federal law called the FDA Amendments Act, adopted in 2007, requires trial sponsors to register applicable studies on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit summary results information to the database within 12 months after the trial’s primary completion date. A rule went into effect in 2017 to strengthen reporting requirements.
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