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# FDA Presses for Clinical Trial Reporting Compliance
- URL: https://www.fdaweb.com/fda-presses-for-clinical-trial-reporting-compliance/
- Published: 2025-09-26T12:00:00.000Z
- Updated: 2026-09-14T15:22:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159942

FDA is stepping up efforts to close persistent gaps in clinical trial reporting, warning that incomplete or delayed disclosures threaten public trust and scientific progress. An [online post](https://www.fda.gov/news-events/fda-voices/fda-focuses-closing-clinical-trial-reporting-gap-research-integrity?utm%5Fmedium=email&utm%5Fsource=govdelivery) from CDER director **George Tidmarsh** notes that clinical trial transparency is “an ethical obligation under the Declaration of Helsinki” and a cornerstone of responsible medical research.

The FDA Amendments Act of 2007 required trial sponsors to register and post results on *ClinicalTrials.gov* and rules clarifying those obligations took effect in 2017, giving the agency oversight authority, and yet compliance remains a problem, Tidmarsh says.

“Recent research shows that many sponsors still don’t report their results information to ClinicalTrials.gov,” he writes. “I co-authored a study that published in January 2025 in the *Journal of the Academy of Public Health* examining how reporting rates changed after the new rules went into effect. A study, ‘[Compliance with Results Reporting at ClinicalTrials.gov Before and After the 2017 FDAAA Final Rule: A Comparative Analysis](https://publichealth.realclearjournals.org/research-articles/2025/01/compliance-with-results-reporting-at-clinicaltrials-gov-before-and-after-the-2017-fdaaa-final-rule-a-comparative-analysis/?ref=fdaweb.com)’ found that while there were improvements in reporting rates following the 2017 Final Rule, particularly in NIH-funded studies, many trials remain non-compliant with reporting requirements.”

To address the reporting compliance shortfall, FDA and the Clinical Trials Transformation Initiative have recommended that academic medical centers adopt proactive, centralized systems to manage *ClinicalTrials.gov* submissions, Tidmarsh says. The agency is also working with the National Library of Medicine to expand training and resources for institutions and investigators.

Additionally, FDA is urging sponsors of studies not legally required to report results to voluntarily register and submit data, emphasizing that broader transparency strengthens both science and patient trust.