The US is taking steps to overhaul its clinical trials process in an effort to counter China's growing influence in the biotechnology industry. Health and Human Services Secretary Robert F. Kennedy Jr. announced the plans, citing the need to prevent the US from falling behind China.
What happened
According to Kennedy, the US is "losing the race" against China in clinical trials, with China now conducting more clinical trials than the US. The World Health Organization's International Clinical Trials Registry Platform reports that China has over 7,100 registered new clinical trials this year, compared to roughly 6,000 in the US. The high cost of developing new drugs in the US, which can reach around $2 billion over a decade or more, is a driving factor in the shift towards China.
The new project, nicknamed SURPASS, involves issuing grants to outside partners to address the clinical trial system's inefficiencies, including costly redundancies that delay progress. The goal is to work with researchers in the private sector and academia to generate rigorous evidence faster, reduce unnecessary costs and burdens, and make the US the best place in the world to engage in clinical trial research.
Other initiatives, such as the Food and Drug Administration's Operation Trial Blazer, aim to reduce early-stage clinical trial times down to 6 to 12 months instead of multiple years. The Center for Medicare and Medicaid Services will also be part of the ARPA-H program, sharing relevant data from electronic medical records and insurance claims to help develop programs that incentivize physicians to inform patients about relevant clinical trials.
