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.

“A recent study found that China conducts more early-stage clinical trials than the United States,” Kennedy wrote in an editorial published online by Fox News. “In 2025, Chinese companies accounted for nearly half of global pharmaceutical licensing deal activity. Those trends should concern every American.”

The editorial was published the same day HHS announced what it called a “coordinated, department-wide effort to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments and ensure that patients have access to the most innovative therapies in the world.”

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 is collecting public comments 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.

“FDA estimates that these changes could reduce development timelines by 6 to 12 months,” Kennedy wrote. “The agency has also clarified that, in many cases, one high-quality clinical trial supported by confirmatory evidence may provide the basis for approval.”

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’s editorial does not provide details about how to do that.

“With this editorial, there is a suggestion that the system is not working,” she said. “In actuality, it would be helpful for us to see exactly where the system specifically failed and then develop an action plan.”

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.

“The FDA probably needs more people with expert backgrounds to review,” she said. “We’ve lost a huge amount of people over the past year at the FDA, and I think that slows that process.”

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.

“We’d love stuff to be faster, but lighting a fire under my feet doesn’t make it faster, and it certainly doesn’t make it better,” she said. “We have a great system that really keeps the American public’s health in the forefront.”

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.