FDA may crack down on clinical trial reporting

FDA is signaling that it may start fining clinical trial sponsors if they fail to meet legal requirements to publicly register trials and report results at ClinicalTrials.gov, or if they report false or misleading information.

In draft guidance released Thursday entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” the agency said it plans to take a risk-based approach, prioritizing clinical trials “of public health importance,” as well as trial sponsors that have a history of previous non-compliance with reporting requirements. It will also assess civil monetary penalties for clinical trial reporting violations that are uncovered in conjunction with investigations of non-compliance with other statutory or regulatory requirements...