亚洲社会药学

本期目录

2021年, 第16卷, 第3期　刊出日期：2021-09-20 上一期    下一期

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EU Real-World Evidence Supports New Drug Research and Development Decisions and Its Implications for China Yang Lingling, Xu Fengxiang 2021 (3):  197-202.  摘要 ( 507 )   PDF(927KB) ( 352 )   Objective To analyze the application of EU real-world evidence in the decision-making of new drug research and development (R&D), and to provide policy recommendations for China’s government to make new drug R&D decisions. Methods The relevant policy documents of the EU on the development of new drugs and other domestic and foreign literature on the real-world evidence were analyzed to obtain the role and application of the current EU real-world evidence in the implementation of new drug development policies. Results and Conclusion At present, the EU is carrying out the national synchronous scientific advisory policy, urging the formation of a European innovation framework, and providing decision-making for new drug R&D selection and program design based on real-world evidence. It is recommended that China build a real-world medical database and design a new drug screening platform to help companies, scientific research institutions assess target drugs. In addition, a national scientific advisory platform should be set up to integrate scientific research strength and provide technical support for new drug R&D institutions. 相关文章 | 计量指标

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Real-World Evidence Supporting New Drug Review and Approval in European Union and Its Enlightenment to China Lan Yipeng, Huang Zhe 2021 (3):  203-208.  摘要 ( 435 )   PDF(793KB) ( 387 )   Objective To analyze the application of real-world evidence (RWE) in the field of medicine in European Union, and provide suggestions for RWE supporting the review and approval of new drugs in China. Methods The European Medicines Agency (EMA) and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE. Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun. The decision-making process includes three stages such as new drug research and development, review, and approval. However, there are some challenges in data quality, research methods, evidence sufficiency, and research process of RWE supporting the European Union in reviewing and approving new drugs. At present, RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs. At the same time, RWE also can promote the development and application of Traditional Chinese Medicine (TCM) and help find out the potential value of TCM such as new indications. 相关文章 | 计量指标

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The Enlightenment of EU Real-World Evidence Supporting the Inclusion of Rare Disease Drugs in Medical Insurance Decisions to China Yu Zhongyi, Xu Fengxiang 2021 (3):  209-213.  摘要 ( 325 )   PDF(728KB) ( 376 )   Objective To study the use of real-world evidence by EU and its member states for establishing a strategy for rare diseases and provide references for the inclusion of orphan drugs in China’s medical insurance. Methods A case analysis method was used to introduce the EU’s decision to include rare disease drugs in medical insurance by using real-world evidence because clinical data of rare diseases were difficult to obtain. Results and Conclusion China can use real-world evidence to make medical insurance decisions based on the experience of the EU and continue to invest more in rare diseases, which can solve the problem of few drugs for patients with rare disease. 相关文章 | 计量指标

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EU Real-World Evidence Supports the Expansion Indications for Drugs and Its Enlightenment to China Wang JiaoJiao, Huang Zhe 2021 (3):  214-218.  摘要 ( 336 )   PDF(780KB) ( 399 )   Objective To analyze the value of EU real-world evidence (RWE) in supporting the expanded indications for drugs and to provide reference for the decision-making of expanding drug indications supported by RWE in China. Methods By searching relevant domestic and foreign literature and case analysis, the practice of the RWE of EU to support the expansion indications for drugs was investigated. Results and Conclusion The EU uses RWE to carry out adaptive path research, which provides a new idea for drug R&D and approval. Besides, it also provides evidence in supporting the research of expanded indications for drugs. With the increasing cognition of RWE, it will play a key role in medical and regulatory decisions in China. 相关文章 | 计量指标

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Research on Real-World Evidence and Application in EU and Its Enlightment to China Wang Chao, Lian Guiyu 2021 (3):  219-224.  摘要 ( 425 )   PDF(778KB) ( 320 )   Objective To analyze the research and application status of real-world evidence (RWE) in the European Union (EU) and provide a reference for China’s government. Methods By consulting the policy guidelines issued by EU EMA and the documents of European countries at home and abroad, the basic principles and case notes of EU RWE implementation were comprehensively analyzed. Results and Conclusion Research on RWE in EU is mainly carried out from four aspects: R&D decision, application of expanded trial certificate, medical insurance decision, and supervision decision, which plays an important role in the progress of European clinical medicine. Therefore, researchers in China should draw lessons from these four perspectives and design reasonable research directions and programs. 相关文章 | 计量指标

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The Enlightenment of FDA’s “Real-World Evidence Program Framework” to China Yu Xiuna, Li Wanying, Dong Li 2021 (3):  225-229.  摘要 ( 339 )   PDF(789KB) ( 390 )   Objective To provide a reference for China to use real-world evidence (RWE) in drug approval and regulatory decision-making system. Methods The main content of “Real-World Evidence Program Framework” issued by the FDA was summarized by literature research method, and the related system construction in China was analyzed. Results and Conclusion To promote the use of real-world study (RWS) for drug regulatory decisions, China should issue guidelines on RWS. Besides, the construction of data standards and the shared database should be strengthened. Then, the demonstration projects should be introduced extensively and the guidance for RWS of enterprises must be enhanced. Meanwhile, close attention should be paid to dealing with the relationship between stakeholders. 相关文章 | 计量指标

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Application of Real-World Evidence in Regulatory Decision-Making for Medical Devices Huang Xianqin, Chen Chuhan, Dong Li 2021 (3):  230-237.  摘要 ( 403 )   PDF(776KB) ( 392 )   Objective To understand the real-world study (RWS) and its application in domestic and foreign pharmaceutical device regulatory decision-making, so as to promote its further application in the decision-making of medical devices supervision in China. Methods Literature analysis and comparative analysis were used to compare the real-world evidence (RWE) and randomized controlled trials to obtain the development status of medical devices in China and the United States. Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages, which can make up for the deficiencies of traditional clinical data. In addition, the RWE has a wide range of applications in the field of medical devices in China. In recent years, the RWE has received extensive attention in the medical field in the United States. The FDA has issued related guidelines, and its applications have gradually formed a complete system. Research on RWE will become the development trend of clinical evaluation of medical devices in the future. While attaching importance to the development of the RWE, China should learn from the specifications of relevant foreign organizations to improve its development in the field of health. 相关文章 | 计量指标

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How Real-World Evidence Supports Healthcare Decisions in EU and Its Enlightment to China Li Longxiao, Lian Guiyu 2021 (3):  238-241.  摘要 ( 424 )   PDF(757KB) ( 263 )   Objective To summarize the concept, background, application value of real-world evidence (RWE) and its enlightenment to China based on the analysis of the information about the RWE supporting health decision in the European Union, and to provide a reference for Chinese health departments. Methods Through literature research and data collection, the requirements of EU countries, especially some typical countries, for clinical evidence in health decision were obtained, and the application of RWE in supporting health decision in EU was analyzed with specific cases. Results and Conclusion RWE plays an increasingly important role in supplementing the evidence base of clinical trials, verifying the safety and effectiveness of medical devices, and accelerating the market access of new drugs. With the improvement of RWE quality, RWE will not only be used in the evaluation of biological agents and chemical drugs, but also play an important role in the evaluation of traditional Chinese medicine and the post-marketing evaluation of medical devices. 相关文章 | 计量指标

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Research on the Pragmatic Clinical Trial Design Based on Real-World Study Li Gan, Zhang Yu, Yuan Xiaoliang, Chen Yuwen 2021 (3):  242-249.  摘要 ( 423 )   PDF(763KB) ( 313 )   Objective To introduce the concept and plan design of pragmatic clinical trials based on real-world study (RWS) so as to provide both guidance for clinical trials and reference for relevant personnel studying RWS. Methods A retrospective study was made on the design of real-world clinical trials at home and abroad in recent years to summarize their design process and applications. Results and Conclusion The advantages of combining randomization and real-world data in clinical trials are important methods for evaluating medical interventions in the real clinical environment. Practical clinical trials can evaluate the therapeutic effects of interventions in real or close to real medical environments to obtain the best real-world evidence. 相关文章 | 计量指标

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Research on Retrospective Studies of Real-World Study and Its Selection Bias Wang Chuang 2021 (3):  250-255.  摘要 ( 459 )   PDF(747KB) ( 343 )   Objective To provide references for improving the authenticity and reliability of the retrospective study results, thus improving the quality of evidence in the real world and strengthening drug supervision and decision-making. Methods Literature review was used to study the data sources, the characteristics of retrospective research, the sources and the corrections of selective bias in the real world. Results and Conclusion The biases in retrospective study mainly come from admission rate bias, patient rate bias, survivors bias, health user bias and symptom bias. 相关文章 | 计量指标

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Discussion on the Application of Real-World Study in the Inheritance and Development of Empirical Prescriptions of Traditional Chinese Medicine Wang Yuzhuo, Li Wanting, Fan Guangwei, Chen Yuwen 2021 (3):  256-263.  摘要 ( 400 )   PDF(798KB) ( 281 )   Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine (TCM). Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study (RWS) were analyzed by summarizing the previous RWS and the empirical prescriptions. Meanwhile, the methods for marketing of new TCMs derived from empirical prescriptions of TCM, the data source and trial design of the RWS were discussed. Results and Conclusion RWS can provide new ideas for the listing of new TCMs. With the improvement of relevant laws and regulations, RWS will promote the development of TCM greatly. To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM, the government should improve laws and regulations as soon as possible, and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties. 相关文章 | 计量指标

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Analysis of Drug Use in Outpatients with Hypertension Based on Real-World Study Wang Lili 2021 (3):  264-271.  摘要 ( 436 )   PDF(807KB) ( 366 )   Objective To explore the situation and trend of drug use in the treatment of hypertension in outpatient department of a hospital, and to provide reference for clinical rational drug use. Methods The data of 833 outpatients with hypertension in a hospital from July to December in 2020 were retrospectively analyzed. Results and Conclusion Among the 833 cases, calcium channel blocker (CCB) was the most frequently used drug (38.54%), followed by angiotensin receptor blocker (ARB) (13.81%), β-receptor blockers (β-RB) (10.44%), angiotensin-converting enzyme inhibitor (ACEI) (5.52%), and diuretics (0.72%). The combination rate was 37.09% (including single-pill combination, SPC). The highest rate was the combination of two drugs (28.21%), followed by the combination of three drugs (8.64%) and four drugs (1.20%). The DDDs and DDC of SPC were the highest among the six kinds of drugs. The use of antihypertensive drugs in outpatient department of the hospital is in line with the medication guidelines, but a small number of drugs are used irrationally, which needs further supervision and management. 相关文章 | 计量指标

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Research Hotspots and Trends Analysis of Real-World Data Based on Social Network Analysis and Knowledge Graph Li Jiahui, Zhao Peiyao, Yuan Xiaoliang 2021 (3):  272-279.  摘要 ( 457 )   PDF(1393KB) ( 299 )   Objective To study the research status, research hotspots and development trends in the field of real-world data (RWD) through social network analysis and knowledge graph analysis. Methods RWD of the past 10 years were retrieved, and literature metrological analysis was made by using UCINET and CiteSpace from CNKI. Results and Conclusion The frequency and centrality of related keywords such as real-world study, hospital information system (HIS), drug combination, data mining and TCM are high. The clusters labeled as clinical medication and RWD contain more keywords. In recent 4 years, there are more articles involving the keywords of data specification, data authenticity, data security and information security. Among them, compound Kushen injection, HIS database and RWD are the top three keywords. It is a long-term research hotspot for Chinese and western medicine to use HIS to study clinical medication, clinical characteristics, diseases and injections. Besides, the research of RWD database has changed from construction to standardized collection and governance, which can make RWD effective. Data authenticity, data security and information security will become the new hotspots in the research of RWD. 相关文章 | 计量指标