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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: In an editorial, RFK Jr. described what agencies are doing to streamline early-stage clinical trials. An expert told Healio that a major factor slowing down trials is a lack of personnel at the FDA. HHS Secretary Robert F. Kennedy Jr. wants to speed up clinical trials in the United States. \u201cA recent study found that China conducts more early-stage clinical trials than the United States,\u201d Kennedy wrote in an editorial published online by Fox News. \u201cIn 2025, Chinese companies accounted for nearly half of global pharmaceutical licensing deal activity. Those trends should concern every American.\u201d
The editorial was published the same day HHS announced what it called a \u201ccoordinated, department-wide effort to strengthen America\u2019s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.\u201d In his editorial, Kennedy said HHS is taking actions to remove barriers to clinical research within the FDA, NIH, Office of the National Coordinator for Health Information Technology and the Advanced Research Projects Agency for Health. According to an NIH press release, these include strengthening NIH support for clinical trials, using electronic health records to find patients who are eligible to participate, and evaluating the use of AI in early-stage trials. The FDA will begin collecting public comments on June 24 about a proposed pilot program that would reduce phase 1 clinical holds, implement a rolling submission process to speed up FDA reviews and allow institutional review board reviews to be conducted at the same time that the agency is reviewing investigational new drug applications. \u201cFDA estimates that these changes could reduce development timelines by 6 to 12 months,\u201d Kennedy wrote. \u201cThe agency has also clarified that, in many cases, one high-quality clinical trial supported by confirmatory evidence may provide the basis for approval.\u201d Earlier this year, the FDA proposed an initiative for real-time clinical trials, which would allow the agency to track progress while trials are ongoing. The comment period for that proposal ends June 29. Additionally, the Office of Inspector General is seeking feedback on the federal anti-kickback statute to see if exceptions should be made to protect health care professionals from being penalized for accepting compensation for referrals. Sharon Nachman, MD, director of the office of clinical trials at the Stony Brook University Renaissance School of Medicine, told Healio that she would love to improve enrollment and expedite clinical trials, but said Kennedy\u2019s editorial does not provide details about how to do that. \u201cWith this editorial, there is a suggestion that the system is not working,\u201d she said. \u201cIn actuality, it would be helpful for us to see exactly where the system specifically failed and then develop an action plan.\u201d In her opinion, Nachman said a lack of personnel is one of the main factors that slows down clinical trials. She said the proposed FDA pilot program may help, but only if the agency has enough expert reviewers. \u201cThe FDA probably needs more people with expert backgrounds to review,\u201d she said. \u201cWe\u2019ve lost a huge amount of people over the past year at the FDA, and I think that slows that process.\u201d She said communication between pharmaceutical companies and the FDA is very slow because it has to follow specific standard operating procedures. She suggested that updating some of the procedures could improve timeliness. Nachman argued that a one-size-fits-all approach will not work to speed up clinical trials, because every trial is different and may require a unique solution. \u201cWe\u2019d love stuff to be faster, but lighting a fire under my feet doesn\u2019t make it faster, and it certainly doesn\u2019t make it better,\u201d she said. \u201cWe have a great system that really keeps the American public\u2019s health in the forefront.\u201d For more information: Sharon Nachman, MD, is a distinguished professor and Knapp Endowed Chair of Pediatrics at Renaissance School of Medicine at SUNY Stony Brook. She also serves as associate dean for research and director of the office of clinical trials. She can be reached at pediatrics@healio.com. Ask a clinical question and tap into Healio AI’s knowledge base.
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