GCP中心

中国中医科学院西苑医院临床药理研究所

Institute of Clinical Pharmacology of Xiyuan Hospital, China Academy of Chinese Medical Sciences

 

中国中医科学院临床药理研究所是医院临床科研的重要技术支撑部门,其前身是卫生部于1983年首批通过的14个部属国家药物临床药理基地之一,是卫生部第一批临床药理培训中心,是我国最早进入GCP建设的中医单位,1995年经国家中医药管理局和中国中医科学院批准正式成立中国中医科学院临床药理研究所,2012年成为国家中医药管理局中药临床药理重点学科建设单位,是国家“九五”、“十五”、“十一五”、“十二五”GCP平台建设单位

自建立以来,承担了国家级临床试验相关重大课题 15余项,中药新药临床试验200余项,先后与国内外60余家制药企业及研究机构合作合作,是国内最早开展中药(植物药)I期临床耐受性和药代动力学试验的研究机构。

近20年来,临床药理研究所依托国家“十五”、“十一五”、“十二五”GCP平台建设课题的实施,逐步完善内涵建设,培养了一批专业化、职业化的各类临床研究人员队伍,出版了我国第一部中药临床药理学专著,建立了符合国际规范的中药临床评价研究技术平台,在临床试验关键技术的研究、受试者保护体系的建设、电子化数据管理、质量控制等方面形成了自己的特色

The national clinical trial department of the Xiyuan Hospital at the China Academy of Chinese Medical Sciences (CACMS) is the first TCM with access to GCP construction. The clinical trial department of the Xiyuan Hospital was approved as the first group of clinical pharmacological centers by the Ministry of Health of China in 1983, and they were responsible for GCP training. In 1995,CACMS approved the clinical trial department of the Xiyuan Hospital as a clinical institute of pharmacology.With the objective of improving the quality of TCM clinical research, the national clinical trial department of the Xiyuan Hospital consists of DME and EBM research room, data management and statistics room, phase I unit, quality control office, archives, and a CRC office, providing sufficient theoretical and technical support for clinical research of new Chinese medicine.The leadership team includes Prof. Tang Xudong, Prof. Liu Jianxun, Prof. Weng Weiliang, and Prof. Gao Rui. There are thirteen research group members, including 5 people with senior professional titles. We have 22 experts evaluating the new medication from State Food and Drug Administration (SFDA), as well as 12 national clinical departments, including the cardiovascular department, hematopathy department, respiratory department, digestive department, surgery, paediatrics, neurology, endocrinology department, E.N.T. department, oncology department, ophthalmology department, and geriatrics department.

Since its inception, the Research Institute of Clinical Pharmacology has undertaken 15 significant research projects, more than 200 clinical trials of new medication of Chinese medicine, and we have built co-operative relationship with over 60 domestic and international pharmaceutical companies. And our institute is the first TCM research institute to carry out the tolerability and pharmacokinetics research of Chinese medicine (botanicals) of Phase I clinical trial. 

We have also trained a group of high-quality technology and management personnel engaging in TCM clinical research and methodology research of clinical evaluation, established technology platform of clinical evaluation of new Chinese medication complying with international norms, making the general level of research, design, management of clinical trial meet international requirements.

  


临床药理所成果展示

Exhibition 

国家重点科研项目

科技部“九五”计划1035工程

科技部“863”攻关计划“中药新药临床试验规范化研究”课题

十五”,国家863计划“中国临床试验关键技术及平台研究”课题

十一五”,国家科技支撑计划“重大疑难疾病中医防治研究”项目“中医临床研究的方案优化及质量控制研究”课题

科技部科技重大专项“以心血管病为示范的中药新药临床评价研究技术平台”课题

十二五”,科技部重大专项“重大新药创制”项目“创新药物研究开发技术平台建设”课题

行业专项“中医慢病临床科研体系及其成果转化应用模式研究”、“临床科研一体化信息平台建设”

国家中医药管理局中医药标准化项目“中医药临床诊疗标准研究推广基地建设”

北京市中医药科技项目“‘样本量再估计’适应性设计方法在中药临床试验中的探索性研究”

国家自然基金青年科学基金项目“中西医合作脾胃病医患共建式循证病历探索研究”

National key scientific research projects

1035 project” in the “Ninth Five-Year Plan” 

“Standardization of Clinical Research of New Chinese Medication”, National High-tech R&D Program (863programs)

Key technology and platform research of TCM clinical trial”,in the 863 programs of “Tenth Five-Year Plan” 

Scheme Optimization and Quality Control for TCM Clinical Research” project in the “Prevention and Treatment of Difficult and Complicated Diease of TCM”plan of “Eleventh Five-year Plan

Technology Platform of Clinical Evaluation of new Chinese medication through Demonstration of Cardiovascular Disease Clinical Trials”,National Science and Technology Major Projects of Ministry of Science and Technology of China in“Eleventh Five-year Plan

Platform of research and technical development of investigational product”program, of “Drug discovery research initiative”Project of major national science and technology projects in“Twelfth Five-year Plan

Clinical research system of TCM on chronic disease and transformation model of achievements”, “The construction of integrated information platform of clinical research”Special projects of Traditional Chinese Medicine

Base construction of Chinese medicine clinical diagnosis standard”, Project of TCM standardization in State Administration of TCM of the People's Republic of China

“Re-estimation of sample size, an exploratory research on adaptive design in clinical research of TCM”, Science and technology project of Beijing Chinese medicine

“The exploratory study of evidence-based medical record about doctor-patient building through joint efforts of integration oftraditional and western for digestive system diseases”, National Natural Science Foundation of China


受试者保护体系

2010年6月在北京地区率先通过了WHO FERCAPSIDCER认证

2013年5月通过SIDCER复核检查

2013年3月通过世界中医药学会联合会中医药临床研究伦理审查平台评估

已正式申请美国人类医学研究委员会(AAHRPP)认证

The Construction of the Subjects Protection Mechanism

As the first hospital in Beijing passing the SIDCER certification of World Health Organization (WHO) and Forum for Ethical Review Committees in the Asian & Western Pacific Region (FERCAPin June 2010

Passing SIDCER recheck in May 2013

Passing the ethical review platform evaluation of clinical research of TCM of World Federation of Chinese Medicine Societies(WFCMS)

Application for the accreditation of AAHRPP

     


网络化临床试验数据管理平台

建立了基于网络技术的数据管理及采集系统,并于2014年1月成功通过NNIT公司的系统验证,现已在新药临床研究及重大临床科研项目中应用

目前有22个临床研究项目(包括70个临床试验分中心)应用该系统

数据的采集采用CDISC(Clinical Data Interchange Standards Consortium)标准

参与国家食品药品监督管理局药品审评中心临床试验电子数据采集EDC技术指导原则的编写

Internet-based Clinical Trial Data Management System Platform 

The Internet-based data management system of clinical trial had been established and passed System Vertification and testing by NNIT in January 2014

Clinical trial data management system has been applied in 22 clinical research projects and over 70 clinical research currently

The Clinical Data Interchange Standards Consortium (CDISC) was adopted in data acquisition

Participated in clinical trials of electronic data collection (EDC) technical guidelines written for CDE


著作

《中医临床药理学》《中药新药临床试验设计与实施》、《中医临床研究实施方案设计与优化》、《中医临床研究实施过程质控与管理》、《中药上市后再评价关键技术》、《中药注射剂临床应用指南》、《中药临床合理应用手册》、《中成药临床合理应用手册》、《中药不良反应与合理用药》

在国家核心期刊发表论文百余篇

国家教育部、中华中医药学会和北京市等各级科学技术奖项5项

Composition

Published eight professional books in recent 5 years

Published more than 100 articles in national core journals

Obtained 5 science and technology awards from Ministry of Education and China Association of Chinese Medicine


GCP中心