[關(guān)鍵詞]
[摘要]
藥品臨床綜合評價以人民健康為中心、以回歸藥品臨床價值為導向,對多維度的臨床數(shù)據(jù)進行綜合分析,是藥品決策的重要技術(shù)工具和循證證據(jù)來源。同時,臨床綜合評價也是對新藥上市后的使用監(jiān)測與監(jiān)管,能夠更好地滿足患者的用藥需求。隨著近年來各類新型抗腫瘤藥品獲批上市或進入臨床試驗階段,很多腫瘤患者因此獲益并對腫瘤治愈有了更高的期望。以腫瘤患者需求和臨床價值為導向,抗腫瘤藥品價值評估框架和評價體系已在全球各國逐步形成,也成為當今新藥審評審批、藥品目錄準入決策的工作重點。對藥品臨床綜合評價的研究進展和抗腫瘤藥物臨床綜合評價的體系建設進行綜述,分析我國目前抗腫瘤藥物臨床綜合評價及衛(wèi)生技術(shù)評估存在的問題與不足,并提出相關(guān)思考與建議,以期為臨床綜合評價相關(guān)工作提供參考。
[Key word]
[Abstract]
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.
[中圖分類號]
R979.1
[基金項目]