The United States government has started a joint strategy involving several agencies to improve the country's clinical research systems and respond to the growing number of early-stage trials taking place in China.

美國政府已開始實施一項涉及多個機構的聯合策略，以改善該國的臨床研究系統，並應對在中國日益增加的早期試驗數量。

This strategic change is driven by the concern that the U.S. is losing its lead in medical innovation. Recent data shows that China has overtaken the United States in the number of early-stage clinical trials, with Chinese companies handling nearly 50% of global pharmaceutical licensing in 2025. Experts emphasize that this shift is a serious risk, because when early research moves abroad, it often causes scientific talent, investment, and essential infrastructure to leave the country.

這次策略轉向是由於擔心美國正在醫療創新方面失去領先地位。近期數據顯示，中國在早期臨床臨床試驗的數量上已超越美國，到 2025 年，中國公司處理了全球近 50% 的藥品授權。專家強調，這種轉變是一個嚴重風險，因為當早期研究移至海外，往往會導致科學人才、投資及重要基礎設施離開美國。

To address this, the Department of Health and Human Services (HHS) is leading a coordinated effort. The Food and Drug Administration (FDA) is launching a pilot program to speed up early-stage trials, which could reduce development times by six to twelve months. Furthermore, the FDA is requesting a permanent, faster approval process for new drugs in the 2027 budget. At the same time, the National Institutes of Health (NIH) is using artificial intelligence and cell-based models to improve treatments, while other offices are using electronic health records to find patients for trials more efficiently.

為了應對此問題，衛生及公共服務部 (HHS) 正領導一項協調行動。食品藥品監督管理局 (FDA) 正推出一項試行計畫以加速早期試驗，這可將開發時間縮短六至十二個月。此外，FDA 在 2027 年的預算中，要求為新藥建立一個永久且更快速的審批流程。與此同時，美國國家衛生研究院 (NIH) 正利用人工智慧及基於細胞的模型來改善治療方法，而其他部門則利用電子健康紀錄來更高效地尋找試驗患者。

Additionally, other agencies are developing new safety technologies and reviewing rules on how participants are paid. These changes are necessary because the industry is currently inefficient. Research suggests that about 30% of trial data is not actually useful for making decisions, which shows that collecting too much unnecessary information may be slowing down the overall process.

此外，其他機構正開發新的安全技術並審查參與者獲報酬的規則。這些改變是必要的，因為目前該產業效率低下。研究顯示，約 30% 的試驗數據實際上對決策沒有幫助，這表明收集過多不必要資訊可能會減慢整體進度。

The U.S. government is now introducing regulatory and technological changes to remove obstacles to clinical research and regain its competitive position in the global pharmaceutical market.

美國政府目前正引入監管與技術上的改變，以消除臨床研究的障礙，並奪回在全球藥品市場的競爭地位。