US clinical trial reforms avoid China and Australia models

The US Department of Health and Human Services is moving to speed clinical trials through an initiative called Operation TrialBlazer, motivated by China’s growing share of global trials. According to a report from marginalrevolution.com, China surpassed the United States in total registered clinical trials in 2024, with over 7,100 trials representing 39% of the global total. The article notes that China uses investigator-initiated trials for cell and gene therapy, radioligand therapy, and stem cell therapy, allowing drugs to move into human testing if a researcher has interest and funding. Australia is also cited as a leader, with its Clinical Trial Notification System allowing trials to begin in fewer than 70 days after a final protocol is submitted, and regulatory approval granted in as little as 21 to 28 days. Operation TrialBlazer proposes reforms such as clarifying Chemistry, Manufacturing, and Controls requirements, but the article states the US is not adopting either China’s investigator-initiated approach or Australia’s system of regulatory notification without prior evaluation. The US architecture retains full FDA regulatory authority and decision-making, focusing on making the gatekeeper faster rather than removing it.

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Sources: marginalrevolution.com