美国食药监局发布实体瘤早期临床试验方案指引草案，意见征求至2027年1月11日
美国食品药品监督管理局（FDA）发布题为「实体瘤早期试验性新药（IND）方案建议」的指引草案，相关通知于11月12日刊登《联邦公报》，公众意见征求期至2027年1月11日。
这份由FDA肿瘤卓越中心参与制定的草案，针对在实体瘤患者中开展的首次人体试验与早期阶段临床试验，就试验方案的设计提出建议，涵盖药物与生物制品。草案不涉及血液系统恶性肿瘤。
FDA表示，早期试验方案的设计直接关系受试者的安全与权益保障，清晰的方案建议有助于申办方在试验启动前把剂量递增、安全性监测等关键要素设计到位。
该指引是卫生与公众服务部「Operation Trialblazer」相关工作的一部分，旨在提升美国临床试验启动的效率与质量。指引草案阶段不具约束力，最终文本将根据公众意见修订。
（来源：美国食品药品监督管理局）
FDA Draft Guidance Targets Early-Phase Solid Tumor Trial Protocols; Comments Due January 11
The U.S. Food and Drug Administration has issued a draft guidance, "Early-Phase IND Protocol Recommendations for Solid Tumors," with the notice published in the Federal Register on November 12 and comments due by January 11, 2027.
Developed with the FDA's Oncology Center of Excellence, the draft addresses the design of first-in-human and other early-phase clinical trial protocols in patients with solid tumors, covering both drugs and biologics. It does not address hematologic malignancies.
FDA said early-phase protocol design bears directly on protecting the safety and rights of trial participants, and that clear protocol recommendations help sponsors build in key elements such as dose escalation and safety monitoring before a trial begins.
The guidance forms part of the Department of Health and Human Services' "Operation Trialblazer" effort to improve the speed and quality of U.S. clinical trial start-up. Draft guidance is nonbinding and will be revised in light of public comments.
(Source: U.S. Food and Drug Administration)
来源：美国食品药品监督管理局
发布：GSM·美国（发布链接）
图片来源：美国食品药品监督管理局总部（GSM固定图库） / U.S. Food and Drug Administration headquarters (GSM asset library)
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