The document provides a detailed overview of ClinicalTrials.gov, emphasizing its role as a public registry and results database for clinical studies involving human participants, encompassing interventional trials, observational studies, and expanded access programs across more than 200 countries. Managed by the National Institutes of Health (NIH), ClinicalTrials.gov facilitates transparency, accountability, and accessibility of clinical research by requiring study sponsors and investigators to submit essential trial information, both at registration and following trial completion. The site receives substantial use—with tens of thousands of weekly submissions and over a million unique monthly visitors—demonstrating its importance to public, professional, and research stakeholders.
Key discussion points include the evolution of reporting requirements under frameworks such as the FDA Amendments Act (FDAAA 801), the International Committee of Medical Journal Editors (ICMJE) policy, and the NIH Clinical Trials Disclosure Policy. The document elucidates specific obligations regarding trial registration and results reporting, including submission timelines, required data elements (such as adverse events, protocols, and statistical analysis plans), and potential penalties for noncompliance—including fines and loss of funding. While regulatory updates have clarified and expanded requirements, concerns remain regarding privacy, data-sharing, administrative burden, and harmonization across international policies. The report concludes by advocating for coordinated leadership among funders, institutions, investigators, and journals to support accurate reporting and enhance the integrity and utility of clinical research data.
