2026-04-28T18:07:24.79Z / 路透社
作者：艾哈迈德·阿布勒内因
2026年4月28日 美国东部时间下午6:07 更新于2小时前
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美国马里兰州银泉市美国食品药品监督管理局（FDA）总部外的标识牌，2020年8月29日摄。路透社/安德鲁·凯利/资料照片
- 该项目旨在减少试验延误，将药品审批时间缩短数年
- 试点将使用聚合信号，不获取原始患者数据
- 马卡里提及全球竞争：自2021年起中国领跑一期临床试验
华盛顿4月28日路透电 —— 美国食品药品监督管理局周一启动一项试点项目，允许该机构实时监控临床试验数据。FDA表示，这一举措有望将药品审批时间缩短数年，并维持美国与中国的竞争力。
该计划旨在消除FDA局长马蒂·马卡里在记者电话会上所称的药物研发“停滞期”。他表示，从早期试验到提交审批决定的整个流程中，行政任务和文书工作占了45%的时间。
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强生公司（JNJ.N）等制药商表示，他们已开始使用人工智能优化监管文件准备工作，将该流程从数百小时缩短至约15分钟。
该计划让FDA能够直接获取一期试验数据，以评估安全性和有效性信号，无需先交由药企进行内部分析和繁琐的文件准备。
FDA称，其已通过健康科技公司Paradigm Health收到并验证了阿斯利康（AZN.L）一项中期试验的安全性数据。该试验针对未接受过任何前期治疗的套细胞淋巴瘤患者开展了药物测试。
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FDA首席人工智能官员杰里米·沃尔什表示，该计划不同于现有数据共享框架，因为FDA不会要求获取原始患者记录。
相反，该机构将仅接收聚合信号，例如不良反应发生率或肿瘤应答率，使监管机构能够在无需处理基础临床数据的情况下做出决策。
沃尔什称，患者个人记录仍将由试验赞助商保管，可避免患者隐私担忧。
另一项试点正在安进公司（AMGN.O）推进中，该公司正对一种尚未扩散至胸腔以外的肺癌患者开展早期试验，即局限性小细胞肺癌。该研究的站点选择工作仍在进行中。
FDA已于今年夏季发布信息征集请求，征求行业和公众对扩大试点项目设计的意见。该机构表示将在5月29日前接受评论，预计7月敲定最终遴选标准，并于8月完成试点项目的选定工作。
马卡里将该计划与他所称的日益激烈的国际竞争联系起来。他表示，中国大约在2021年就一期临床试验的数量上超过了美国，并称此后该数字呈指数级增长。
艾哈迈德·阿布勒内因报道；朱莉·斯廷胡伊森在芝加哥补充报道；比尔·伯克罗特编辑
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US FDA to monitor clinical trial data in real time in pilot program aimed at speeding approvals
2026-04-28T18:07:24.79Z / Reuters
By Ahmed Aboulenein
April 28, 2026 6:07 PM UTC Updated 2 hours ago
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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
- Program aims to reduce trial delays, cut years off drug approval timelines
- Pilot uses aggregated signals, avoids raw patient data
- Makary cites global competition; China leading Phase 1 trials since 2021
WASHINGTON, April 28 (Reuters) – The U.S. Food and Drug Administration launched a pilot program on Monday aimed at allowing the agency to monitor clinical trial data in real time, a step the agency said could cut years from drug approval timelines and keep the U.S. competitive with China.
The initiative aims to eliminate what FDA Commissioner Marty Makary in a call with reporters called “dead time” in drug development. He said administrative tasks and paperwork take up 45% of the time involved in getting a drug from early testing to submission for an approval decision.
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Johnson & Johnson JNJ.N and other drugmakers have said they have started using artificial intelligence to streamline preparation of documents for regulators, cutting that process from hundreds of hours to about 15 minutes.
The initiative gives the FDA access to Phase 1 trial data for assessing safety and efficacy signals without it first going to the company for its own analysis and painstaking preparation.
The FDA said it had received and validated safety data from a midstage trial run by AstraZeneca AZN.L through health technology firm Paradigm Health testing a drug for mantle cell lymphoma in patients who had not received any prior treatment.
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FDA Chief AI Officer Jeremy Walsh said the initiative differs from existing data-sharing frameworks because the FDA is not seeking access to raw patient records.
Instead, the agency would receive only aggregated signals, such as rates of adverse side effects or tumor response percentages, allowing regulators to make decisions without handling underlying clinical data.
Individual patient records would remain with the trial sponsor, avoiding patient privacy concerns, Walsh said.
A second pilot is underway with Amgen AMGN.O, which is conducting an early-stage trial in patients with a form of lung cancer that has not yet spread beyond the chest, known as limited-stage small cell lung carcinoma. Site selection for that study is still ongoing.
The FDA published a request for information seeking industry and public input on the design for broadening the pilot program this summer. The agency said it would accept comments until May 29, with final selection criteria expected in July and pilot selections to be completed in August.
Makary linked the initiative to what he described as growing international competition. He said China surpassed the United States in the number of Phase 1 trials being conducted around 2021 and described the growth since as exponential.
Reporting by Ahmed Aboulenein; Additional reporting by Julie Steenhuysen in Chicago; Editing by Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.
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