Study Says FDA Should Step Up Trial Reporting Enforcement

When the FDA gets tough on clinical trial transparency, the industry listens. The problem is the FDA doesn’t get tough with enough regularity.

That’s the upshot of research published in the Journal of the American Medical Association (JAMA) Nov. 12, which showed that 90 percent of those conducting clinical trials who got preliminary warnings from the FDA about overdue clinical trial results promptly provided the requested information.

The researchers — which include Reshma Ramachandran, a postdoctoral fellow at the Yale University School of Medicine and a board member of Universities Allied for Essential Medicines, a nonprofit that presses for clinical trial disclosure and transparency — argue that the FDA should be more aggressive at pushing drugmakers, universities and National Institutes of Health grantees for transparency in their trial results.

“The FDA can and should harness its enforcement tools to ensure timely submission of trial results information to ClinicalTrials.gov,” wrote the researchers. “By doing so, the FDA could bring important missing results to light and demonstrate its commitment to protecting patients through clinical trial transparency.”