ClinicalTrials.gov and the US Government Shutdown: What Sponsors Need to Know

The ongoing US government shutdown is affecting ClinicalTrials.gov operations. Sponsors are uncertain about whether their clinical trial registrations are being processed or publicly posted.

Studies required under US law or policy are continuing to be processed. These include studies that are:

• Applicable Clinical Trials (ACTs)
• Required by NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
• Funded by US government agencies
• Conducted in one or more US states

For other studies not covered by these requirements, sponsors are reporting delays in public posting. While ClinicalTrials.gov has not issued comprehensive public guidance, current information indicates that sponsors and investigators are experiencing varying levels of success in releasing study records through the PRS during the shutdown.

These delays have implications beyond the US. Delayed registration may impact journal eligibility, ethical compliance, and transparency obligations under the International Committee of Medical Journal Editors (ICMJE), Good Clinical Practice (GCP), and the Declaration of Helsinki. They may also create compliance risks for sponsors operating in countries where registration on an international registry, often ClinicalTrials.gov, is required or accepted as the designated platform for meeting national trial registration requirements.

The ICMJE has not issued any new or specific guidance related to the US government shutdown or registry service disruptions. However, the ICMJE’s existing Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals note that the date of first submission of registration materials is considered the trial’s official registration date, even if public posting is delayed. Editors may follow up with authors to understand the reasons for substantial delays between submission and posting. Authors are also expected to explain any registration delays or unusual circumstances in their manuscript cover letters.

What sponsors should do now

To maintain compliance and transparency during this disruption:

• Document all registration attempts, including screenshots, timestamps, and submission confirmations.
• Retain all communications with ClinicalTrials.gov or registry administrators as evidence of due diligence.
• Consider temporary registration with an alternate WHO Primary Registry to preserve transparency and meet publication requirements.
• Monitor status updates from ClinicalTrials.gov and relevant agencies; processing rules may evolve.
• Coordinate internally with publication, medical writing, and regulatory teams to ensure consistent messaging and timelines.

Potential alternative registries

The following registries are WHO Primary Registries that accept global studies. Please note that some of these registries are noticing an increase in submissions and may not be able to accommodate them in a timely manner.