刘述森 王小岩 孙皛 林毅楠

    摘 要 真实世界证据已受到全球制药工业的广泛重视，可用来支持药品适应证和适用人群扩展的申请。不过，申请的标准路线图尚未明确，一般需通过评估药品潜力、评估外部资源、制定研究计划、事先报备方案、进行研究实施、提交研究报告和申请报告等一系列流程才能进入审评审批阶段。依循循证医学理念，利用真实世界证据，可为扩展药品用途创造必要的条件，使药品发挥最大的价值。

    关键词 真实世界证据 适应证扩展 适用人群

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2021)03-0003-03

    Considerations of the application of real-world evidence in supporting the expansion of drug new indication or new indicated population

    LIU Shusen1*， WANG Xiaoyan1， SUN Xiao1， LIN Yinan2

    (1. Digital China Health Technologies Co.， Ltd.， Beijing 100080， China； 2. Beijing Fuming Medical Health Exchange Center， Beijing 100043， China)

    ABSTRACT Real-world evidence (RWE) has drawn worldwide attention in pharmaceutical industry as its potential to support the application of expanding drug indication and applicable population. However， standard route has not yet formulated. Normal procedures before review and approval stage include drug potential evaluation， external resource evaluation， study protocol development， protocol filing， study execution， report submission and application. Applying RWE with evidence-based medicine ideology can create far-reaching influence on the exploration of drugs and thus maximize their value. ......