In an effort to restore American leadership in clinical research, the U.S. Department of Health and Human Services (HHS) is launching a department-wide initiative to strengthen domestic research capacity and increase participation in clinical trials in the U.S.
Working alongside academic medical centers, contract research organizations, and health care providers, the HHS announced in a June 22 press release that the department is seeking to bring more clinical research and investment back into the U.S.
HHS Secretary Robert F. Kennedy Jr. said in the release that the initiative is a resolution to the rise in overseas clinical research, which the department described as a threat to America’s role as global leader in biomedical innovation.
“America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas,” he said.
The Food and Drug Administration (FDA), National Institutes of Health, and Office of the National Coordinator for Health Information Technology are implementing new strategies as part of the initiative. According to the release, planned measures include reducing regulatory and administrative delays, expanding research efforts focused on rare diseases and cancer, and modernizing clinical trial design and operations.
The release noted that the FDA is seeking public comment on a proposed pilot program and issuing new guidance that could shorten some early-stage clinical trials by six to 12 months.
All efforts, the release said, are aimed at ensuring the “next generation of medical breakthroughs” occur in the U.S.
“America led the world in medical innovation before,” Kennedy said. “We will lead again.”