The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) submitted joint comments to the National Library of Medicine (NLM) regarding the planned modernization of ClinicalTrials.gov. They commend the NLM’s efforts and note that the current system faces challenges due to its dual role: serving both the general public and the scientific community. Originally designed for public transparency and focused on trials for serious diseases, ClinicalTrials.gov has expanded to encompass a broader range of studies, including those required by sponsors and journals. This expansion, without concurrent system updates, has created usability issues for researchers, who find the platform ill-suited for newer types of studies and overly burdensome in its administrative requirements.
The organizations recommend forming a stakeholder user group involving investigators and system administrators to help guide redevelopment efforts. They advocate for both a public-friendly interface for study participants and contextual research results, and a more efficient, investigator-oriented experience with features such as integrated links to funding databases, improved data coding for NIH trials, refined study status reporting, automated notifications, and clear indicators of study type and regulatory obligations. They also suggest considering a separate system for non-clinical studies to reduce confusion and administrative load. Overall, AAU and COGR stress the importance of modernization, reduced administrative burden, and improved transparency to better serve all stakeholders.
