Drugs

Improve FDA ClinicalTrials.gov Enforcement: Researchers

Researchers from Yale and Columbia universities say FDA “can and should harness its enforcement tools to ensure timely submission of trial results information to ClinicalTrials.gov. By doing so, FDA could bring important missing results to light and demonstrate its commitment to protecting patients through clinical trial transparency.”

Writing in a JAMA viewpoint column, the researchers say reporting of results information remains limited despite a legal mandate in the 2007 FDA Amendments Act (FDAAA) and clear instructions from HHS and a National Institutes of Health (NIH) final rule.

The researchers say they looked at all 58 FDA pre-notice alerts sent to companies that failed to submit trial results. “The 57 pre-notices represent a tiny fraction of the thousands of FDAAA-applicable clinical trials identified as noncompliant with results information reporting requirements as of 1/2021,” the article says.

The authors note that FDA sent the pre-notices to drug companies and academic institutions and not to any federal agencies, even though NIH is the responsible party for many trials that have not submitted mandated results to ClinicalTrials.gov.

Suggestions the authors have for strengthening FDA enforcement are:

· send more pre-notices;
publicize all pre-notices that are issued;
ensure that pre-notices present clear timelines for further enforcement action if results remain unreported; and
if FDA resources or personnel remain constrained, set and consistently apply objective criteria for prioritization of enforcement efforts.

The article also says NIH could take steps to identify non-compliant trials and send reminders to the responsible parties.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome