药品临床综合评价以人民健康为中心、以回归药品临床价值为导向，对多维度的临床数据进行综合分析，是药品决策的重要技术工具和循证证据来源。同时，临床综合评价也是对新药上市后的使用监测与监管，能够更好地满足患者的用药需求。随着近年来各类新型抗肿瘤药品获批上市或进入临床试验阶段，很多肿瘤患者因此获益并对肿瘤治愈有了更高的期望。以肿瘤患者需求和临床价值为导向，抗肿瘤药品价值评估框架和评价体系已在全球各国逐步形成，也成为当今新药审评审批、药品目录准入决策的工作重点。对药品临床综合评价的研究进展和抗肿瘤药物临床综合评价的体系建设进行综述，分析我国目前抗肿瘤药物临床综合评价及卫生技术评估存在的问题与不足，并提出相关思考与建议，以期为临床综合评价相关工作提供参考。

The comprehensive clinical evaluation of drugs is centered on people's health and guided by the return to the clinical value of drugs. Comprehensive analysis of multi-dimensional clinical data is an important technical tool and evidence-based evidence source for drug decision-making. At the same time, clinical comprehensive evaluation is also the monitoring and supervision of the use of new drugs after marketing, which can better meet the drug needs of patients. In recent years, with the approval of various new anti-tumor drugs on the market or entering the clinical trial stage, many tumor patients benefit from this and have higher expectations for tumor cure. Guided by the needs of tumor patients and clinical value, the value evaluation framework and evaluation system of anti-tumor drugs have been gradually formed in countries all over the world, and have also become the focus of today's new drug review and approval and drug catalog access decisions. This paper reviews the research progress of clinical comprehensive evaluation of drugs and the construction of clinical comprehensive evaluation system of antitumor drugs, analyzes the problems and deficiencies of the current clinical comprehensive evaluation of antitumor drugs and health technology evaluation in China, and puts forward relevant thoughts and suggestions, in order to provide reference for the related work of clinical comprehensive evaluation.

R979.1