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OBJECTIVE To construct a comprehensive evaluation index system for anti-lung cancer drugs， and to provide a basis for drug selection and rational clinical use. METHODS Based on the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （2021 edition for trial use）， a preliminary evaluation index system framework and an index preselection pool were initially formulated through literature analysis. The evaluation indices were then selected and modified by using the Delphi method. The weights of each index were determined through expert scoring and relevant calculations， thereby establishing a comprehensive evaluation index system for anti-lung cancer drugs. Referred to Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions， scoring detailed rules for clinical comprehensive evaluation indexes of anti-lung cancer drugs were formulated. The constructed comprehensive evaluation index system and scoring detailed rules were applied to conduct empirical evaluation of the anti-lung cancer drug pembrolizumab. RESULTS The constructed comprehensive evaluation index system for anti-lung cancer drugs included 6 primary indicators and 15 secondary indicators. The weights of the primary indicators were as follows： safety （18）， efficacy （38）， economy （15）， innovation （9）， suitability （10）， and accessibility （10）. The scoring detailed rules for the comprehensive evaluation index system for anti-lung cancer drugs had been preliminarily established. The results of empirical evaluation showed that the comprehensive evaluation score （61 points） of pembrolizumab combined with chemotherapy regimen was higher than that of the monotherapy chemotherapy regimen （56 points）. The former demonstrated superior efficacy， innovation and suitability compared to the latter， while the latter exhibited better safety and economy. CONCLUSIONS The constructed comprehensive evaluation index system for anti-lung cancer drugs has the potential for generalizability and practical application， providing a reference basis for rational clinical drug use.
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OBJECTIVE To explore standardized evaluation process for clinical comprehensive evaluation of blood lipid- regulating drugs and perform rapid assessment of clinical comprehensive evaluation of blood lipid-regulating drugs with different mechanisms so as to provide reference for the drug catalogue selection and rational drug use of medical institutions. METHODS Referring to guidelines and consensus such as the guideline for the management of comprehensive clinical evaluation of drugs， the methods such as literature research， expert interviews， and Delphi expert consultation were used to establish a multi-dimensional and multi-criteria clinical comprehensive evaluation index system and quantitative scoring table for blood lipid-regulating drugs around the two main lines of technical evaluation and policy evaluation. Then 13 blood lipid-regulating drugs with different mechanisms in 21 third-grade class-A medical institutions from five provinces and regions of Northwest China were scored from both technical and policy dimensions to form a comprehensive evaluation result. RESULTS The clinical comprehensive evaluation index system and corresponding rapid evaluation quantitative scoring table were constructed for blood lipid-regulating drugs in the five northwest provinces and regions. The technicalevaluation section included 6 primary indicators， 13 secondary indicators， and 34 tertiary indicators， totaling 110 points. The policy evaluation section included 4 primary indicators and 6 secondary indicators， with a total score of 40 points （30 points for some drugs） and a total score of 150 points （or 140 points）. The scoring results showed that the highest score was atorvastatin， followed by rosuvastatin and simvastatin. CONCLUSIONS Statins are still the cornerstone of drug therapy for patients with dyslipidemia； the rapid evaluation quantitative scoring table constructed in this study is comprehensive， systematic and operable. The evaluation process in this study can provide empirical references for other groups to exploring the standardized path and quality control mechanism of clinical comprehensive evaluation of drugs.
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OBJECTIVE To conduct a c omprehensive clinical evaluation method of Chinese patent medicine ，and to provide reference for rational clinical drug use. METHODS Taking the top 10 Chinese patent medicine injections for promoting blood circulation and removing stasis in Shandong province from 2016 to 2020 collected by the National Rational Drug Use Monitoring Network as an example ，the method combining health technology assessment with objective judgement analysis is used to construct the comprehensive evaluation index system ；based on evidence-based medical evidence and pharmacoeconomic model ，the safety ， effectiveness and economy of the drug were evaluated comprehensively ，and the scores were quantified. RESULTS & CONCLUSIONS The final scores of the 10 kinds of Chinese patent medicine injections were between 26 and 37 scores. Safflower yellow for injection scored the highest score in the treatment of cerebral infarction and angina pectoris of coronary heart disease ， while Ginkgo diterpene lactone meglumine injection and Shuxuening injection had the highest scores in the treatment of coronary heart disease. The clinical comprehensive evaluation method of Chinese patent medicine based on evidence-based medical evidence and pharmacoeconomic model can clarify the comprehensive value of Chinese patent medicine in clinic ，promote rational drug use in clinic ，and provide basis for the next adjustment of medical insurance catalogue and essential medicine catalogue ，decision-making of centralized procurement of related drugs.
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OBJECTIVE To provide reference for scientifi c and standardized development of clinical comprehensive evaluation of drugs in China. METHODS Guided by the theory of total quality management （TQM），drawing lessons from the successful experience of the British and German conducting evaluation ，combining with plan-do-check-act cycle and other quality management methods and tools ，drug clinical comprehensive evaluation of total quality management system was constructed in accordance with the requirements for our country related policy and local practice. RESULTS & CONCLUSIONS To construct total quality management system of clinical comprehensive evaluation of drugs in China from 5 aspects of organization system ，management process，assessment system ，evaluation and supervision platform ，support and guarantee mechanism. The organization system included national ，provincial and medical institutions ；management process should focus on the key links in the 3 stages of theme selection，evaluation and implementation ，and result transformation and application ；assessment system ，evaluation and supervision platform，support and guarantee mechanism should be established together so as to further improve the scientificity ，rationality， practicality and standardization of total quality management of clinical comprehensive evaluation of drugs. The development of total quality management is an effective starting point to promote the continual improvement of the drug clinical comprehensive evaluation；relevant government departments and the implementation of evaluation of medical institutions should further set up quality management consciousness ，establish report quality feedback mechanism and the results co-constructing and sharing mechanism and strengthen professional personnel training and innovation synergy regulation mode to ensure that the authenticity and reliability of evaluation results.
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OBJECTIVE：To prom ote the implementation of clinical comprehensive evaluation of drugs in China ，promote the return of drugs to clinical value ，improve the utilization efficiency of limited resources ，and provide reference for decision makers of health departments. METHODS ：By combing the relevant policy documents and literatures of clinical comprehensive evaluation of drugs，the evolution and research progress of relevant policies in China were introduced ；the advanced experiences （including evaluation subjects ，evaluation value dimensions ，evaluation methods ，evaluation procedures and results applications ）of Canada ，the United States ，the United Kingdom ，Australia，Europe，International Society for Pharmacoeconomics and Outcomes Research and other countries （regions/organizations）were analyzed and summarized ；relevant suggestions on the construction of China ’s clinical comprehensive evaluation mechanism for drugs were put forward. RESULTS & CONCLUSIONS ：It is suggested that the following measures should be taken to construct the clinical comprehensive evaluation mechanism of drugs in China including that the development goal and orientation of clinical comprehensive evaluation of drugs should be further clarified with the guidance of decision-making needs ；the government should play a leading role and strengthen inter departmental cooperation and policy coordination；the traceability quality control system of internal and external standards should be established ，adhere to openness ， fairness and fair ；at the same time ，it is suggested to give full play to the role of informatization and big data ，strengthen the exploration of evaluation methodology and standards ，strengthen the transformation and application of evaluation results ，and promote the service of evaluation results to policy decision-making.