The Council on Governmental Relations (COGR) and the Association of American Universities (AAU) submitted comments to the National Library of Medicine regarding the modernization of ClinicalTrials.gov. They commend the National Library of Medicine for addressing the need to update the system, which has evolved beyond its original purpose of serving both the public and scientific communities since its inception following the Food and Drug Administration Modernization Act of 1997. ClinicalTrials.gov, initially designed for registering trials related to investigational new drug applications and primarily aimed at public transparency, now faces challenges due to expanded requirements to register various types of studies and publish results, including those not originally envisioned, such as pilot and behavioral trials.
COGR and AAU highlight issues such as the system's lack of adaptability to new types of data, insufficient alignment between grant and trial statuses, and increasing demands from journal editors for broader study registration to ensure transparency. They emphasize that the current system burdens investigators with administrative tasks ill-fitted to its templates, leading to inefficiencies and reduced clarity for both researchers and the public. The organizations recommend engaging stakeholders in system redesign, creating more user-friendly interfaces for both the public and investigators, integrating data with other databases to minimize manual entry, and developing clearer study status indicators. They also suggest considering separate processes for non-clinical trials to further reduce administrative burdens. Overall, the submission underscores a commitment to improving transparency and efficiency while facilitating compliance for research institutions.
