The United States (U.S.) has long led the world in biomedical discovery, translation into clinical research, and approvals of new cures and life-changing treatments. But even as biomedical science accelerates the identification of these potentially transformative therapies, America’s clinical research enterprise is not keeping pace. Most clinical research in the U.S. remains fragmented and reliant on separate data, measurement, and process requirements that do not fit well into routine care. The resulting costs and burden of clinical research limit patient access and slow the generation of evidence needed to guide treatment.
Key actors in the biomedical innovation ecosystem are developing an increasingly rich array of public and private resources to address this critical challenge. Yet despite these efforts, clinical research integrated into care remains the exception, and other countries are more rapidly progressing to improve the speed and efficiency of both early-stage (e.g., Phase 1 clinical trials) and more advanced clinical development.
This draft framing report describes the current inefficiencies of U.S. clinical research, highlights the need for modernizing the U.S. clinical trial enterprise while also advancing early-stage drug development, and conceptualizes the next generation of drug development and regulation in the U.S. We propose a series of practical policy initiatives to further enable U.S. actions that advance the global use of aligned, modernized standards for clinical development across regulatory agencies.
Read the full document here.