HHS kicks off new programs to speed clinical trials as Chinese competition looms

Dive Brief:

• The Trump administration on Wednesday unveiled new efforts to speed U.S. pharmaceutical research as competition from foreign countries increases.
• The programs include “Surpass,” which “envisions a future in which clinical development operates as a continuous learning system rather than a sequence of disconnected trials.” The five-year program is soliciting proposals from teams with innovative ideas in three major areas while offering government funding and support.
• At the same time, the Advanced Research Projects Agency for Health — or ARPA-H — is kickstarting three projects designed to speed clinical trial enrollment, build “nationwide data infrastructure” and better empower patients involved in research. “These efforts will address multiple barriers that slow clinical trial development today,” the Health and Human Services Department said in astatement.

Dive Insight:

Health officials are trying to make the U.S. more enticing as a location for clinical trials as countries including Australia and China increasingly attract pharmaceutical research. China’s share of global Phase 1 clinical trials surpassed the U.S. for the first time in 2021, and in 2024 the country registered a higher total of all registered clinical studies for the first time, according to an HHSmemoreleased last month.Australiahas also seen gains; it has one of the highest trials-per-capita rates in the world.

Compared with the U.S., China and Australia offer speed, lower costs and less regulatory burden. In Australia, drugmakers can begin clinical trials between six and 12 months earlier than in the U.S., and studies may cost half as much, according to a recent thinktankreport. China, meanwhile, has proven especially attractive to pharmaceutical companies, with licensing dealsbooming.

The latest U.S. government efforts come on the heels of the Food and Drug Administration’sOperation Trialblazer, which is designed to speed up early clinical trials for new medicines through the use of qualified research institutions. And it comes days after the leaders of nine European pharmaceutical makerswarnedtheir industry is also quickly losing ground to China.

A main focus for the Surpass project is on building a “phaseless design engine” instead of the current system, which requires significant regulatory coordination between phases of research. The program is also looking for teams that can develop a system that offers real-time or on-demand analysis for faster decision making and an “agentic operations layer” to automate many research activities.

Today, the development of a new drug takes about 10 years and costs between $1 billion and $2 billion, with sponsors ultimately failing more than 90% of the time, according to HHS documents. With innovations, it may be possible to cut timelines in half and achieve a 10-fold reduction in costs, Daria Fedyukina, the Surpass program manager,told Axios.