北京大学医学部药物评价中心是经北京大学医学部批准，以北京大学第三医院（药剂科）为依托，联合药学院（药事管理与临床药学系）、公共卫生学院（流行病与卫生统计学系）、第一医院（药剂科）、人民医院（药剂科）、肿瘤医院（药剂科）和国际医院（药剂科）等6家单位，于2016年12月共同组建的药物评价研究机构。

　　中心致力于充分整合北京大学医学部药物评价领域的学术资源，以临床为依托，开展药物评价相关的科学研究、技术服务和交流合作，为卫生、医疗保障等政府部门、医疗机构及其他相关单位提供高水平的药物评价研究结果，为医学部药物评价相关学科的发展提供发展平台，助力北大医学发展、服务北京大学“双一流”建设，并不断提高学术研究对政府及临床决策的支撑作用，促进合理用药以及政府和医疗机构的科学决策，推动我国医药卫生体制改革和“健康中国2030”建设。

　　中心围绕药物评价这一主题开展研究，主要研究方向包括：药品卫生技术评估、循证制定临床药物治疗指南和药师主导的药品注册登记研究等。

　　中心依托单位——北京大学第三医院（药剂科）自2000年以来，在药物评价领域广泛开展研究，并建立了一支国内一流的药物评价队伍。药剂科与Cochrane协作网香港分中心、GRADE中国中心、法国埃克斯马赛大学等高水平团队机构等保持合作关系，形成循证药学的战略发展合作关系，促进循证药学研究能力的提高。目前已在SCI杂志及国内统计源期刊上发表药物评价相关论文近200篇（其中SCI 80余篇）。

　　合作单位中，北京大学药学院药事管理与临床药学系从2000年开始围绕药品政策与医药产业发展策略、医药卫生体制改革与医药事业发展策略、药事管理与法规、药物经济学等方面开展研究，促进药物政策与经济学的发展；公共卫生学院流行病与卫生统计学系从20世纪90年代开展药物流行病学研究，为国家药品安全监督部门提供技术咨询，并承担大量的药品上市后安全性研究课题，同时为企业提供咨询和服务；第一医院、人民医院、肿瘤医院等附属医院药剂科多年来广泛开展医院药学、循证药学及个体化用药等相关研究，承担多项国家级和省部级课题，具有坚实的科研能力，在相关学术领域均处于领先地位。

　　在国内率先使用世界卫生组织（WHO）指南制定手册，主持制定了《中国万古霉素治疗药物监测指南》和《伏立康唑个体化用药指南》，是国内前两部被美国国立指南库（NGC）收录的指南。同时，主持制定了国内首部快速建议指南——《基于肠促胰素治疗药物临床应用的快速建议指南》。

　　在国内率先开展20多项药品的卫生技术评估研究，并用于国家医保药品目录的决策支持（8个药品新增列入，另5个药品谈判成功）；牵头北京市卫计委“药物快速经济学评价与医院新药遴选”专项工作，培训了20家医院的40余名药师，开展了40余个药品的快速评估。

　　中心牵头了国内首个由药师主导的大规模、多中心、前瞻性药品上市后安全性再评价的真实世界研究，目前已完成两项3万例研究，为监管部门提供了循证依据；在此基础上，制定了北京市药品重点监测技术指导原则（生产企业）并形成地区标准。

　　

　　机构负责人：翟所迪（中心主任）

　　联系人：门鹏（中心秘书）

　　邮箱：puide@bjmu.edu.cn

　　电话：15600561969

　　地址：北京市海淀区花园北路49号北京大学第三医院药学楼

　　

　　

　　Peking University Health Science Center’s  Institute for Drug Evaluation，PUIDE

 

　　Peking University Health Science Center’s Institute for Drug Evaluation (PUIDE) is a research institute focusing on drug evaluation, which was established in Dec 2016. PUIDE is based on PKU Third Hospital (Department of Pharmacy), in cooperation with PKU School of Pharmaceutical Sciences (Department of Pharmacy Administration and Clinical Pharmacy), PKU School of Public Health (Department of Epidemiology and Biostatistics), PKU First Hospital (Department of Pharmacy), PKU People’s Hospital (Department of Pharmacy), Beijing Cancer Hospital (Department of Pharmacy) and PKU International Hospital (Department of Pharmacy).

　　PUIDE is devoted to fully integrate the academic resources of Peking University Health Science Center (PKUHSC) in the field of drug evaluation and rely on clinical practice to carry out scientific research, technical services and exchange and cooperation related to drug evaluation, and to provide support to government departments, medical institutions and other related departments. The unit provides a high level of drug evaluation research results and a platform for the development of relevant disciplines related to drug evaluation among PKUHSC. PUIDE will boost the development of PKU medicine and healthcare, and serve the "double top-notch" construction of Peking University. PUIDE will also continuously enhance the academic research's supportive role in government and clinical decision-making, promote rational use of medicines and scientific decision-making of government and medical institutions, and ultimately promote the reform of the medical and health system in our country and the construction of "Healthy China 2030" plan.

　　PUIDE conducts research around the topic of drug evaluation. The main fields including: health technology assessment of drugs, development of evidence-based pharmacotherapy guidelines, and pharmacist-led real-world drug evaluation registry studies, etc.

　　Since 2000, Peking University Third Hospital (Department of Pharmacy) has conducted extensive research in the field of drug evaluation and has established a first-class domestic drug evaluation team. Department of Pharmacy has established cooperation with Cochrane Collaboration Hong Kong Branch Center, GRADE China Center, France's Aikesi Marseille University and other high-level team agencies, building evidence-based pharmacy strategic development cooperation and promote evidence-based pharmacy research capabilities. At present, nearly 200 articles on drug evaluation have been published in SCI journals and domestic statistical source journals (among which more than 80 are SCI articles).

　　Among the cooperation units, PKU School of Pharmaceutical Sciences (Department of Pharmacy Administration and Clinical Pharmacy) has focused on  the pharmaceutical policy, the medical and health system reform and development strategy of the pharmaceutical industry, pharmacy regulations and pharmacoeconomics, promoting the development of drug policy and economics; PKU School of Public Health (Department of Epidemiology and Biostatistics)conducted researches on pharmacoepidemiology from the 1990s to provide technical advice to the state’s drug safety supervision department and undertook a large number of post-marketing drug evaluation studies for enterprises to provide advice and services; Over the years, with a solid scientific research ability, PKU First Hospital (Department of Pharmacy), PKU People’s Hospital (Department of Pharmacy), Beijing Cancer Hospital (Department of Pharmacy) and PKU International Hospital (Department of Pharmacy)have carried out a wide range of hospital pharmacy, evidence-based pharmacy and individualized drug researches, undertaken a number of national, provincial and (or) ministerial projects, while in a leading position in the relevant academic fields.

　　For the first time in China, PUIDE used World Health Organization (WHO) Guidelines Development Manual to preside over the development of the "Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society” and “Individualized medication of voriconazole: a practice guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society”, which were the first two Chinese guidelines that included in the National Guideline Clearinghouse (NGC). We also presided over the development of the first rapid advice guideline in China - "A Rapid Advice Guideline of The Clinical Application of Incretin Based Therapies".

　　PUIDE has taken the lead in carrying out more than 20 health technology assessment studies of drugs, using for the decision-making support of the national reimbursement drug list (8 drugs were newly listed, the other 5 drugs were successfully negotiated); we also leaded Beijing Municipal Commission of Health and Family Planning’s "rapid pharmacoeconomics evaluation and hospital new drug selection" special work, training more than 40 pharmacists from 20 hospitals, carrying out more than 40 rapid assessment of drugs.

　　The first pharmacist led, multicenter, prospective, post-marketing drug reevaluation real world study was led by PUIDE. Two real world studies have been conducted currently, and these results have provided evidence for  regulatory authorities.  More than 30,000 patients were included in each study. With the experiences from the real world studies, Guidance for Drug Intensive Monitoring by Pharmaceutical Enterprises in Beijing which was built up in the province level.

　　

　　Director: Suodi Zhai

　　Contact: Peng Meng

　　Email: puide@bjmu.edu.cn

　　TEL: 15600561969