The Trump administration is launching an effort aimed at bringing clinical trials back to the United States, after years of more trials moving overseas, according to a June 22 announcement from the Department of Health and Human Services (HHS).
HHS and some of its divisions, such as the Food and Drug Administration (FDA), are involved in the new effort, dubbed Operation TrialBlazer.
One of the steps is an FDA solicitation of public comments on a proposal for a pilot program that would shorten the period of time from identification of a drug to phase one clinical trials.
Another is outreach by the National Institutes of Health for tips on how it can intervene in trials to make sure they are successfully completed.
The National Cancer Institute is working on a third step involving cancer centers, researchers, and others in the space to streamline the start of trials and boost enrollment in cancer studies.
The developments come after China in 2024 registered more trials than the United States. Pharmaceutical companies have also been using countries outside the United States, such as Australia, to run early trials on potential drugs.
Drugs are often tested in laboratories before being evaluated in phase one trials. If early trials go well, the drugs are advanced to phase two and phase three trials, which are typically required for FDA clearance.
A primary focus of the new effort is to remove bureaucracy and delays from the current framework. For instance, companies often have to wait up to 60 days just to have a meeting about new drugs for which they may seek authorization with the FDA, while companies that are running trials abroad can in many cases move forward without that delay, HHS said in a report outlining the operation.
“Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the report reads.
If successful, officials expect more companies to carry out trials in the United States.
“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,” HHS Secretary Robert F. Kennedy Jr. said in a statement.
Kennedy said that HHS, under President Donald Trump’s leadership, “is launching a coordinated department-wide effort to restore America’s leadership in clinical research, remove unnecessary barriers, and bring more clinical research and investment back to the United States.”
“America led the world in medical innovation before,” he said. “We will lead again.”
Some of the changes had been proposed by outside experts such as the Duke Clinical Research Institute think tank, including cutting the time between each step.









