ABSTRACT
OBJECTIVE To construct the drug clinical comprehensive evaluation index system and quantitative grading in China， and to provide a reference for scientifically carrying out comprehensive clinical evaluation of drugs. METHODS The analytic hierarchy model was used to establish the drug clinical comprehensive evaluation index system， the weight of the evaluation index and the quantitative grading of each index were determined through expert consultation and model calculation. RESULTS The results of expert consultation were integrated by using the analytic hierarchy model， and the drug clinical comprehensive evaluation index system was obtained： including six first-level indicators of effectiveness， safety， economy， suitability， accessibility and innovation， as well as twenty-three second-level indicators of recommended status， medication for special populations， and drug treatment costs； the weight of each indicator was calculated through estimation-matrix method. CONCLUSIONS The analytic hierarchy model can construct the drug clinical comprehensive evaluation index system and quantitative grading in China， which can provide methodological references for comprehensive analysis and decision-making， thus making the clinical comprehensive evaluation of drugs completer and more scientific.
ABSTRACT
At present， there are still some problems in China’s clinical comprehensive drug evaluation， such as the unscientific design of the evaluation content， the nonstandard evaluation method and organizational process， and the evaluation results not meeting the decision-making needs. It is urgent to carry out quality control over the whole process of the clinical comprehensive drug evaluation project. From the technical point of view， the quality control methods of clinical comprehensive drug evaluation are discussed through three links of the evaluation content and design （giving the quality control key points of the theme selection process and scheme design）， the evaluation method （discussing the quality control elements of two common evaluation methods， i. e. documentary evidence method and real-world research） and result application transformation （giving suggestions on quality control from the comprehensive analysis of evaluation results， transformation of evaluation results and decision-making）， so as to promote the quality improvement of clinical comprehensive drug evaluation.