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# FDA, NIH Not Enforcing Clinical Trial Reporting: Report
- URL: https://www.fdaweb.com/fda-nih-not-enforcing-clinical-trial-reporting-report/
- Published: 2020-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:58:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145839

A *Science* investigative report says that FDA and the National Institutes of Health (NIH) are doing little or nothing to enforce a 2007 law and its 2017 final rule requiring recording of most clinical trial results in a federal database so doctors and patients can see whether new treatments are safe and effective. “Few trial sponsors have consistently \[filed the reports\],” *Science* [says](https://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law?ref=fdaweb.com), “(and) many still ignore the requirement, while federal officials do little or nothing to enforce the law.”

The journal examined more than 4,700 trials whose results it says should have been posted at ClinicalTrials.gov under the 2017 rule that clarified the law’s expectations and penalties for failing to disclose trial results. “Reporting rates by most large pharmaceutical companies and some universities have improved sharply,” the report says, “but performance by many other trial sponsors including, ironically, NIH itself, was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit records and other data within one year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 9/25/19, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University-affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine, all among the top 50 recipients of NIH grants in 2019.”

*Science* says that when they were contacted for comment, none of the institutions disputed the findings. In all 4,768 trials the journal checked, sponsors violated the reporting law more than 55% of the time. And, it says, in hundreds of cases where the sponsors were credited with reporting trial results, they have yet to be publicly posted because of quality lapses flagged by ClinicalTrials.gov staff.

The journal reports that an NIH executive said it has been trying to change the culture of how clinical trials are reported and disseminated and has educated researchers about the Web site and improved its usability. For FDA, it says, **Patrick McNally** told an industry conference on ClinicalTrials.gov that the agency “has limited resources and we encourage voluntary compliance.” In response to the *Science* findings, an FDA spokesperson said that an absence of posted results on ClinicalTrials.gov does not mean that a trial sponsor has broken the 2007 law. The journal responds that the law and the final rule detail only a few exemptions that would allow trial sponsors to withhold results on the basis of nonpublic information. “The very few registered trials that qualify for these exemptions are not flagged as violators…,” it says.