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治疗性肿瘤疫苗临床试验的注意事项:美国FDA行业指南介绍 被引量:2

Clinical considerations for therapeutic cancer vaccines: An introduction to FDA guidance for industry
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摘要 治疗性肿瘤疫苗的作用机制不同于细胞毒药物,其临床研究操作规范不能完全套用细胞毒药物的模式,因此迫切需要制定适用于治疗性肿瘤疫苗临床试验的操作规范。2011年11月,美国FDA正式公布了有关治疗性肿瘤疫苗临床试验的行业指南,对早期(Ⅰ、Ⅱ期)和晚期(Ⅲ期)肿瘤治疗临床试验中需注意的问题提出了一系列指导性意见,其内容主要包括肿瘤疫苗临床试验对受试者的选择、临床免疫反应的监测、佐剂的使用、疫苗的延迟效应、伴随治疗和后续治疗的影响、起始剂量和给药方案、剂量递增方案、统计学处理、终点评价指标等。本文尝试对该指南进行解读,将FDA有关肿瘤疫苗临床试验的一系列指导性意见介绍给国内读者,希望引起国内的肿瘤疫苗研究者、临床试验设计者、临床医生以及业务监管部门的重视,并在实际工作中加以借鉴,从而推动我国肿瘤疫苗的临床研究。
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出处 《中国肿瘤生物治疗杂志》 CAS CSCD 北大核心 2014年第4期366-370,共5页 Chinese Journal of Cancer Biotherapy
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