FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity

By: George Tidmarsh, M.D., Ph.D., Director, Center for Drug Evaluation and Research

Clinical trial transparency is fundamental to maintaining public trust in medical research and supports broader scientific advancements among the global clinical research community. The U.S. Food and Drug Administration is keenly focused on clinical trial transparency, which is an ethical obligation under the Declaration of Helsinki and rooted in the fundamental principles of medical research. The Declaration of Helsinki establishes ethical principles for medical research involving human subjects and serves as a cornerstone document for the international medical community, providing guidance on issues such as informed consent and the protection of vulnerable populations in clinical trials. This declaration emphasizes that data transparency is essential for enabling scientific advancements and protecting research participants' rights and well-being.

ClinicalTrials.gov is a website and online database of clinical research studies maintained by the National Library of Medicine (NLM) to promote clinical trial transparency and provide information about clinical research studies to the public, researchers, and health care professionals. ClinicalTrials.gov data is used by patients and health care providers to identify potential research studies and by researchers to conduct secondary research and examine the clinical research enterprise, but its usefulness depends on the research community to submit accurate and timely information.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) mandates that certain clinical trials register and submit results information to ClinicalTrials.gov to ensure that information about ongoing and completed studies is publicly available. The rules clarifying these requirements took effect in 2017, and the FDA provides regulatory oversight to ensure compliance with the registration and results information reporting requirements.

Recent research shows that many sponsors still don't report their results information to ClinicalTrials.gov. 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," 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.

A new study in the Journal of the Academy of Public Health builds on these findings and examines a wider range of clinical trials than just those required by federal law to report their results information. The study, "Sponsor-Level Timely Reporting Performance for ClinicalTrials.gov Requirements: A Comprehensive Analysis," provides a more granular understanding of reporting patterns across the research landscape. The research finds differences in reporting practices across organization types with large industry sponsors generally better at reporting results information compared to academic medical centers (AMCs). Large companies typically have established regulatory affairs departments to manage data transparency obligations, suggesting that having dedicated resources and expertise is important for meeting ClinicalTrials.gov reporting requirements or voluntarily reporting results information.

This is consistent with the results from a project conducted by Clinical Trials Transformation Initiative (CTTI) in collaboration with the FDA, which recommended institutions, including AMCs, adopt a proactive centralized approach to ClinicalTrials.gov registration and results information reporting (CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov). AMCs have a critical role in supporting their researchers by providing resources and expertise to ensure they are meeting federal mandates to report results information. The FDA encourages proactive compliance and along with the NLM provides resources and training to help researchers and institutions meet their reporting obligations.

The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov for clinical trials subject to the FDAAA requirements and encourages voluntary registration and submission of results information to ClinicalTrials.gov for other clinical research studies. We will continue to encourage AMCs, especially considering the critical role they play, in supporting their researchers. The FDA takes its oversight of clinical trials seriously and will continue to hold responsible parties accountable for noncompliance.

For more information:

Clinical Trials and Human Subject Protection

ClinicalTrials.gov