HHS Unveils Bold Plan to Reclaim U.S. Leadership in Clinical Trials

The Department of Health and Human Services today launched a department-wide effort to restore U.S. leadership in clinical research, accelerate drug development, and expand patient access to innovative therapies. Key moves include FDA pilots to shorten early-trial timelines and clarify expectations, NIH support for AI-enabled, well-powered trials, NCATS’ translational advances, NCI’s streamlined trial activation and enrollment, ONC’s patient-trial matching via electronic health records, and ARPA-H initiatives to modernize research—all aimed at reducing delays and strengthening domestic biomedical leadership.