NIH Strengthens Enforcement for Delayed Clinical Trials Reporting

Questions? Contact Clinical Trials Regulatory Support

Overview

The NIH has increased enforcement actions against clinical researchers who fail to submit timely results of NIH-funded clinical trials to ClinicalTrials.gov. The NIH introduced stricter penalties and a more robust monitoring system to hold researchers, institutions, and sponsors more accountable.

NIH Strengthens Enforcement for Delayed Clinical Trials Reporting

All Principal Investigators of National Institutes of Health (NIH) funded clinical trials are required to register their trials on ClinicalTrials.gov and submit summary results information to ClinicalTrials.gov within one year of the completion of data collection from the final study participant.

In August 2022, an Office of Inspector General (OIG) report found that the NIH did not ensure that all NIH-funded investigators complied with federal reporting requirements to submit timely results to ClinicalTrials.gov. In a March 2023 blog post, the NIH reported 96% of NIH-funded clinical trials had reported results to ClinicalTrials.gov, but only 37% submitted results information within the one-year deadline.

A recent article in Science highlights the NIH’s increased enforcement actions against clinical researchers who fail to submit timely results of NIH-funded clinical trials to ClinicalTrials.gov.  The NIH introduced stricter penalties and a more robust monitoring system to hold researchers, institutions, and sponsors more accountable, including:

  • Individually contacting investigators with overdue results to bring them into compliance;
  • Requiring extramural investigators to show proof of trial registration and results reporting before they are able to file the annual progress reports necessary to receive their next year of funding.

The NIH seeks to promote transparency, scientific progress, and patient safety by encouraging the timely dissemination of clinical trial data. Compliance with ClinicalTrials.gov reporting requirements contributes to evidence-based medicine, improves healthcare outcomes, and builds public trust.

If you receive a notification of noncompliance from the NIH, please contact the UCSF ClincialTrials.gov Regulatory Support Team.