The US government has a new plan. They want to make medical research better in the USA.

美國政府有一個新計畫。他們希望改善美國的醫療研究。

China now does more early medical tests than the USA. The US government is worried. They do not want to lose their best scientists and money.

目前中國進行的早期醫療測試多於美國。美國政府對此感到擔心，他們不希望失去頂尖的科學家與資金。

The FDA wants to make tests faster. They want to save six to twelve months of time. The NIH will use AI and computers to help patients.

FDA希望加快測試速度，目標是節省六到十二個月的時間。NIH將利用AI和電腦來協助患者。

Some research is too slow. Some data is not useful. The government wants to fix these problems to make new medicines quickly.

部分研究進展太慢，且有些數據並不實用。政府希望解決這些問題，以快速研發出新藥物。

The US government is changing its rules. They want to be the best in the world for medicine again.

美國政府正在修改規則，他們希望在醫療領域重新成為世界之最。

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。

The United States government has initiated a multi-agency strategy to enhance the domestic clinical research infrastructure and counteract the increasing prevalence of early-stage trials in China.

美國政府已啟動一項多機構協作策略，旨在強化國內臨床研究基礎設施，並應對中國日益增加的早期試驗盛行情況。

The impetus for this strategic realignment stems from a perceived erosion of American leadership in medical innovation. Data indicates that China has surpassed the United States in the volume of early-stage clinical trials, with Chinese entities accounting for nearly 50% of global pharmaceutical licensing activity in 2025. This shift is viewed as a systemic risk, as the localization of early-stage research typically precipitates the migration of scientific talent, capital investment, and critical infrastructure.

此次戰略調整的動力源於美國認為其在醫療創新方面的領導地位有所削弱。數據顯示，中國在早期臨床試驗的數量上已超越美國，且到 2025 年，中國機構佔全球藥品授權活動的近 50%。這種轉變被視為一種系統性風險，因為早期研究的在地化通常會導致科學人才、資本投資和關鍵基礎設施的遷移。

In response, the Department of Health and Human Services (HHS) has coordinated a comprehensive inter-agency effort. The Food and Drug Administration (FDA) is implementing a pilot program to accelerate early-stage trials, with projected reductions in development timelines of six to twelve months. Furthermore, the FDA is seeking the establishment of a permanent, expedited Investigational New Drug pathway via the 2027 fiscal budget. Concurrently, the National Institutes of Health (NIH) is integrating artificial intelligence and human cell-based models to optimize therapy delivery, while the Office of the National Coordinator is leveraging electronic health records to improve patient recruitment.

為了回應，衛生與公共服務部 (HHS) 協調了一項全面的跨機構行動。食品藥品監督管理局 (FDA) 正在實施一項試行計畫以加速早期試驗，預計將開發時間縮短六至十二個月。此外，FDA 正尋求透過 2027 財政預算建立一個永久性的快速新藥申請 (IND) 通道。與此同時，國家衛生研究院 (NIH) 正將人工智慧與人體細胞模型結合以優化治療交付，而國家協調員辦公室則利用電子健康記錄來改善受試者招募。

Complementary efforts include ARPA-H's development of predictive safety and design technologies and the HHS Office of Inspector General's review of participant compensation regulations. These institutional adjustments occur against a backdrop of industry-wide inefficiency; research from the Tufts Center for the Study of Drug Development and TransCelerate suggests that approximately 30% of trial data is non-contributory to key decision-making, highlighting a systemic trend toward excessive data collection that may impede trial efficacy.

配套措施還包括 ARPA-H 開發預測性安全與設計技術，以及 HHS 總督察辦公室對參與者補償法規的審查。這些制度調整是在整個行業效率低下的背景下進行的；塔夫茨藥物開發研究中心與 TransCelerate 的研究表明，約 30% 的試驗數據對關鍵決策沒有貢獻，凸顯了數據收集過多的系統性趨勢，這可能會妨礙試驗的成效。

The U.S. government is currently implementing regulatory and technological reforms to reduce barriers to clinical research and restore its competitive standing in the global pharmaceutical landscape.

美國政府目前正在實施監管與技術改革，以降低臨床研究障礙，並恢復其在全球製藥版圖中的競爭地位。