Clinical Trial Sponsors Still Failing to Report Results Despite Regulations

Key Insights

• A recent investigation reveals that many clinical trial sponsors continue to neglect the mandatory reporting of their results in the federal database, ClinicalTrials.gov.
• Despite a 2007 law and a 2017 "final rule" by the NIH and FDA intended to enforce compliance, many trial sponsors still fail to disclose their findings.
• The lack of enforcement by federal officials allows this non-compliance to persist, hindering doctors and patients from accessing crucial information on treatment safety and efficacy.

For two decades, the U.S. government has advocated for clinical trial sponsors, including companies and universities, to record their trial results in a federal database, ClinicalTrials.gov. This measure aims to provide doctors and patients with access to information regarding the safety and effectiveness of new treatments. However, compliance has been inconsistent, even after a 2007 law mandated reporting for many registered trials.

In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) reinforced this requirement with a "final rule," clarifying expectations and penalties for non-disclosure. This rule took full effect on January 18, 2018, providing ample time for sponsors to comply.

A recent investigation by Science reveals that many trial sponsors continue to disregard the reporting requirement, and federal officials are doing little to enforce the law. This ongoing lack of compliance undermines the transparency of clinical research and limits access to vital information for healthcare professionals and patients.