FDA Urges Over 2,200 Sponsors and Investigators to Submit Missing Trial Results

The FDA has contacted more than 2,200 clinical trial sponsors and investigators about missing results submissions to ClinicalTrials.gov, citing ongoing gaps in required reporting. 

The outreach focuses on applicable clinical trials, primarily interventional studies of FDA-regulated products that fall under US reporting requirements. These trials must report results within one year of completion. 

Results reporting typically involves submitting structured summary data to ClinicalTrials.gov, including participant enrollment, baseline characteristics, outcome measures and adverse events.

Phase I and device feasibility studies are excluded from this analysis. 

The FDA news release shared that 29.6% of studies likely subject to these requirements have not submitted results.

When negative trial results are not disclosed, the public record can become incomplete. The FDA said this can contribute to publication bias and affect understanding of the safety and efficacy of medical products. 

On March 30, 2026, the agency contacted organizations and researchers associated with more than 3,000 registered trials that appear to be missing required results information or may not have completed the National Library of Medicine’s quality control review process. The messages were intended to encourage voluntary compliance before the agency considers further regulatory action.

Under current regulations, the FDA may issue Pre-Notices of Noncompliance and Notices of Noncompliance as part of risk-based compliance efforts related to ClinicalTrials.gov reporting. 

The March 30 outreach was described as an additional step before the agency considers whether to take those measures. Public reporting of trial results can support clinicians, researchers and patients by making study findings more accessible, including negative or inconclusive results.

FDA Commissioner Marty Makary emphasized the ethical obligation of sponsors to disclose all trial results, while Tracy Beth Hoeg, Acting Director of the Center for Drug Evaluation and Research (CDER), supported the initiative to enhance patient safety and informed decision-making.

In March 2026, the FDA also issued draft guidance on new approach methodologies, or NAMs, outlining how non-animal data may be used in drug development to support preclinical safety and pharmacology assessments. The guidance describes how data from laboratory models, computational approaches and other human-relevant systems can be evaluated for regulatory use.

Early this year, the FDA has also issued guidance on adaptive clinical trial designs and Bayesian methods in drug and biologic development. These approaches address trial design, analysis and evidence generation in specific regulatory contexts.

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