News

FDA signals heightened enforcement focus on ClinicalTrials.gov compliance

17 April 2026

The U.S. Food and Drug Administration (FDA) recently reminded more than 2,200 clinical trial sponsors to submit clinical trial results to ClinicalTrials.gov. The reminders follow an agency analysis finding that nearly 30% of studies that are “highly likely” to be subject to mandatory ClinicalTrials.gov reporting requirements have no results posted. In prior guidance, FDA indicated that it would more definitively assess potential violations during inspections conducted as part of its Bioresearch Monitoring Program as well as in response to complaints.

FDA emphasized that the failure to disclose negative or unfavorable trial results distorts the public record and creates a misleading picture of product safety and efficacy, framing ClinicalTrials.gov compliance as both a legal and ethical obligation.

Although the March 30, 2026 communications asked for “voluntary compliance,” this move may suggest increased agency willingness to move beyond informal reminders in this area. As we have previously discussed, FDA enforcement of ClinicalTrials.gov requirements has been sporadic, with the agency issuing its first public Notice of Noncompliance only in 2021, followed by limited subsequent public action. However, this current initiative is both data‑driven and openly framed as a compliance and enforcement priority, with senior leadership underscoring that failure to post results deprives clinicians, patients, and researchers of critical information needed for treatment decisions.

Importantly, sponsors of certain marketing applications are also required to submit Form FDA 3674 to certify compliance with applicable ClinicalTrials.gov requirements. Where required results have not been posted, a sponsor may be unable to submit the certification at all or may risk submitting a false certification. As the form itself states, knowingly making a false statement in this certification is a criminal offense. Although criminal enforcement in this context would be highly unlikely, the certification requirement introduces an additional layer of risk and accountability for sponsors.

With FDA signaling greater attention to ClinicalTrials.gov compliance violations, delays that historically drew little attention could carry meaningful regulatory exposure risks. Sponsors and researchers should ensure that they understand their reporting obligations, have effective processes to track reporting deadlines across portfolios, and are able to timely submit required information.

If you have questions about your obligations to post trial information and results on ClinicalTrials.gov and/or if you have missed your deadlines, feel free to contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

Authored by Robert Church, Heidi Gertner, Stephanie Agu, and Eva Marie Schifini