Health and Human Services Secretary Robert F. Kennedy Jr. announced an overhaul of clinical trials for new drugs, a measure he justified as necessary to prevent China from gaining supremacy in the biotechnology industry.
Kennedy announced the new project from the Advanced Research Projects Agency for Health on Wednesday, saying that modernizing clinical trials is a top priority for the Trump administration because the United States “cannot afford to lose” the race against China and other countries for dominance in biomedical innovation.
“It’s just clear to anybody who looks at it that we’re losing the race,” Kennedy said. “China is now doing more clinical trials than we are, and you know we’re not. That’s not just economic benefits that we’re losing. It’s the control of our healthcare, of our health, our international leadership in biomedical research.”
China has rapidly expanded its share of the global clinical trial market in recent years. According to the World Health Organization’s International Clinical Trials Registry Platform, China has over 7,100 registered new clinical trials this year, compared to roughly 6,000 in the U.S.
Cost is a driving reason for the shift toward China and away from U.S. drug market for clinical trials. Developing a new drug in the U.S. can cost around $2 billion over a decade or more, according to HHS, and roughly 90% of new drugs fail along the way.
During the event at the University of Texas at Austin Wednesday, Kennedy said the administration’s goal is to “reform our clinical trial systems so that we can get closer to, you know, to what China is doing and what other nations are doing,” including clarifying expectations with companies and reducing delays.
The new ARPA-H project, nicknamed SURPASS, involves issuing grants to outside partners, such as UT Austin, to address the clunky clinical trial system, which involves costly redundancies that delay progress.
Kennedy said the goal of the new program is to work with researchers in the private sector and in academia to “generate rigorous evidence faster, reduce unnecessary costs and burdens, and make the United States the best place in the world to engage in clinical trial research.”
“These efforts will attack some of the biggest sources of delay in clinical research: repeated trial startups, slow recruitment, disconnected data, limited access to trial sites, and infrastructure that has to be rebuilt study after study,” Kennedy said.
Alicia Jackson, the director of ARPA-H, said other technological advancements that could propel medicine, such as artificial intelligence, will not matter unless they are used to develop drugs or quicken clinical trials.
“If we don’t get this right, who cares if we find the next treatment if it doesn’t get through a clinical trial, or it gets developed overseas? That just won’t matter,” Jackson said, adding, “We can’t afford to screw this up.”
The ARPA-H project coincides with the Food and Drug Administration initiative announced in June, called Operation Trial Blazer, intended to reduce early-stage clinical trial times down to 6 to 12 months instead of multiple years.
Acting FDA Director Kyle Diamantas said during the event in Austin that his agency will be working with ARPA-H to utilize the new clinical trial frameworks built under SURPASS to fast-track drug development.
Diamantas said U.S. leadership in clinical trials is just as essential for everyday patients as it is for national security.
“When clinical trials move offshore, it’s American patients who lose the most,” Diamantas said. “China has made very apparent it is not just targeting early stage trials, but wants American patients reliant on Chinese pharmaceutical companies for their prescriptions.”
Dr. Mehmet Oz, administrator of the Center for Medicare and Medicaid Services, said his agency will also be part of the ARPA-H program to share relevant data from the 160 million electronic medical records and insurance claims of Americans covered by federal health programs.
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Oz also said CMS will be working on developing programs to “push people into clinical trials,” including incentivizing physicians to inform patients about relevant clinical trials.
“If there’s a clinical trial that might change your life for the better or benefit this country and your fellow Americans, we want you to know about that,” Oz said. “We’re looking for more creative ways to help.”
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[ H/T Washington Examiner ]
