药物临床价值评估的主要考虑因素及问题

发布时间：2018-06-27 07:21

本文选题：新药 + 临床价值　；参考：《中国新药杂志》2017年05期

【摘要】：药物研发和评价中的临床价值越来越受到重视。为了提升对药物研发和临床试验中药物临床价值的全面认识,本文从多角度,特别是从药物研发临床评价方面对影响药物临床价值评估的主要因素及问题进行了梳理、总结和分析。包括药物适用的疾病特点、疾病的治疗现状、药物的研发目的和临床定位,药物的临床试验目的和主要疗效指标,影响药物临床价值或临床价值发挥的其他因素等;同时,本文对药物临床价值评估需要关注的几个问题也进行了分析。包括不能仅看单一因素,需要多个因素综合考虑,药物临床价值的有无和临床价值的大小需要充分的证据支持,而不是根据其声称的药物研究目的和临床定位,药物临床价值与其临床试验中主要疗效指标的关系等。这些都是药物研发和上市注册临床试验和评价中需要充分考虑的问题。
[Abstract]:More and more attention has been paid to the clinical value of drug development and evaluation. In order to enhance the comprehensive understanding of the clinical value of drugs in drug research and development and clinical trials, this paper combs the main factors and problems affecting the evaluation of drug clinical value from various angles, especially from the aspect of clinical evaluation of drug development. Summary and analysis Including the disease characteristics of drug application, the current situation of disease treatment, the purpose and clinical orientation of drug research and development, the purpose of clinical trial and the main curative effect index of the drug, and other factors affecting the clinical value or the exertion of the clinical value of the drug, and so on; at the same time, This paper also analyzes several problems that need to be paid attention to in evaluating the clinical value of drugs. Including not just looking at a single factor, requiring a combination of factors, and whether the clinical value of the drug and the magnitude of the clinical value need to be supported by sufficient evidence rather than on the basis of its stated drug research purpose and clinical location, The relationship between the clinical value of drugs and the main therapeutic effects in clinical trials. These are issues that need to be fully considered in clinical trials and evaluations of drug development and registration.
【作者单位】：国家食品药品监督管理总局药品审评中心;
【分类号】：R95

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