ClinicalTrials.gov, the world’s largest clinical trial registry and a cornerstone of transparency in human research, could be substantially improved through targeted changes that go beyond what current regulations require, according to a critical review published in BMC Medical Research Methodology.
The article, authored by Alejandro Rivero-de-Aguilar and colleagues including Mónica Pérez-RÃos, Alberto Ruano-Raviña and Leonor Varela-Lema, examined the registry’s current content and structure. Since its launch in 2000, ClinicalTrials.gov has undergone several regulatory and technical updates, but the authors argue that important challenges remain regarding data quality, usability and adherence to international reporting standards.
The team conducted a critical review of the current version of the registry, examining its different sections in light of relevant meta-research and methodological literature, including the SPIRIT 2025 and CONSORT 2025 statements. Their goal was to identify limitations in the registry’s content and structure and to formulate pragmatic recommendations for improvement.
The analysis identified six major domains in which the registry could be strengthened. The first concerns study identification data, where the authors recommend a clearer characterisation of the connections between trials and the researchers behind them.
The second domain involves methodological data. The authors propose the creation of new dedicated sections, improved structuring of eligibility criteria and outcome measures, and the ability to pre-specify statistical methods within registry entries.
The third domain addresses trial results.
The remaining three domains focus on how users interact with the registry. Patient-centred features could be expanded through a specific section explaining what participation in a trial actually entails. Finally, the authors recommend transparency and quality indicators summarised in a dashboard presenting key information with visual flags.
Overall, the authors propose several approaches to improve ClinicalTrials.gov, including structural changes to the way data are captured and to the website interface. They argue these improvements could increase the registry’s utility for patients, researchers and policymakers, thereby strengthening transparency and accountability in clinical research.
The article is published as open access, with the version shared early to provide faster access to peer-reviewed, accepted research; it is citable and carries a permanent DOI, with a final version of record to follow.
Subject of Research: A critical review of the content and structure of the ClinicalTrials.gov clinical trial registry proposing improvements to reporting quality, transparency and usability.
Article Title: Beyond regulatory compliance: strengthening reporting quality and transparency in ClinicalTrials.gov
Article References: Rivero-de-Aguilar, A., Pérez-RÃos, M., Ruano-Raviña, A., & Varela-Lema, L. (2026). Beyond regulatory compliance: strengthening reporting quality and transparency in ClinicalTrials.gov. BMC Medical Research Methodology. https://doi.org/10.1186/s12874-026-03047-0
Image Credits: AI Generated
DOI: 10.1186/s12874-026-03047-0
Keywords: ClinicalTrials.gov, clinical trial registry, transparency, reporting quality, CONSORT 2025, SPIRIT 2025, meta-research, research methods, patient information, data quality, BMC Medical Research Methodology, Beyond
News Source: Ophelia Keating. (October 27, 2026). Researchers Call for Overhaul of ClinicalTrials.gov Beyond Regulatory Compliance. Scienmag.
