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抗肿瘤药物联合治疗早期临床研发中对于关键要素的审评考量

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联合治疗是抗肿瘤药物增加疗效和克服耐药的重要手段.随着新型抗肿瘤药物的不断出现,不同作用机制和不同类型的药物联合越来越多.从单药扩展到联合用药,对于临床研究的关键要素,如用药人群、给药策略等可能会有所调整,因此在临床研究早期阶段就应该思考如何进行探索,以提高关键注册研究的成功概率,也是业界关注的热点.本文结合既往新药审评经验,阐述当下在早期临床研究时对于联合用药的关键问题或要点的综合考量,以供业界同仁研发参考.
Considerations for crucial elements in early clinical research and development of anti-tumor drug combination therapy
Combination therapy is essential for anti-tumor drugs to increase efficacy and overcome drug resistance.With the emergence of new anti-tumor drugs,there are more and more combinations of the different mechanisms of action and types of drugs.Critical elements of clinical research,such as subject population and delivery strategies,may be adjusted when expanding from a single drug to combination therapy.Therefore,exploring how to improve the probability of successful critical registration studies in the early stages of drug clinical research has always been a concern.This article combines the past review experience to elaborate on how to consider key points in early clinical research of combination drugs,providing a reference for enterprise research and development.

Anti-tumor drugsCombination therapyDosageSafetyEfficacy

仝昕、吕俊、郝瑞敏、宋媛媛、胡文娟、杨志敏

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100076 北京 国家药品监督管理局药品审评中心

抗肿瘤药物 联合治疗 给药剂量 安全性 有效性

2024

临床肿瘤学杂志
解放军第八一医院

临床肿瘤学杂志

CSTPCD
影响因子:1.583
ISSN:1009-0460
年,卷(期):2024.29(1)
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