US EditionFDA crackdown targets unpublished research results
The notices seek voluntary compliance, and the FDA said fines could reach $10,000 a day for missing trial results.
- The FDA issued more than 2,200 notices at the end of March to companies and researchers regarding over 3,000 clinical trials that failed to submit required data to ClinicalTrials.gov.
- An internal FDA analysis revealed almost 30% of studies subject to mandatory reporting failed to submit results, suggesting some entities are suppressing unfavorable outcomes to create public record gaps.
- "Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret," FDA Commissioner Dr. Marty Makary said, emphasizing sponsors have an ethical obligation to disclose results.
- Although the messages seek voluntary compliance, the FDA noted potential civil fines of up to $10,000 a day for Noncompliance, with 232 Pre-Notices issued since 2013 to enforce requirements.
- Dr. Tracy Beth Hoeg of the Center for Drug Evaluation and Research stated the initiative aims to improve patient safety and keep the public informed about product benefits and risks.
20 Articles
20 Articles
FDA pushes drugmakers to report missing clinical trial results
In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines. FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also…
Interventional News
Cardiovascular NewsUS FDA warns thousands of companies and researchers against suppressing unfavourable trial results
The US Food and Drug Administration (FDA) has reminded more than 2,200 medical product companies and researchers of requirements for them to submit certain information on clinical trial results to ClinicalTrials.gov. As stated in a press release from the US FDA, companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that “obscures the true landscape of dr…
FDA pushed drugmakers to report missing trials?
FDA reminder letters demand missing clinical trial results The FDA sent reminder letters to more than 2,200 companies and researchers, underscoring that they are required to report clinical trial results. The trigger is noncompliance: the agency is urging follow through on trials where required…
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