GCP中心

中國中醫科學院西苑醫院臨床藥理研究所

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

 

中國中醫科學院臨床藥理研究所是醫院臨床科研的重要技術支撐部門,其前身是衛生部于1983年首批通過的14個部屬國家藥物臨床藥理基地之一,是衛生部第一批臨床藥理培訓中心,是我國最早進入GCP建設的中醫單位,1995年經國家中醫藥管理局和中國中醫科學院批準正式成立中國中醫科學院臨床藥理研究所,2012年成為國家中醫藥管理局中藥臨床藥理重點學科建設單位,是國家“九五”、“十五”、“十一五”、“十二五”GCP平臺建設單位

自建立以來,承擔了國家級臨床試驗相關重大課題 15余項,中藥新藥臨床試驗200余項,先后與國內外60余家制藥企業及研究機構合作合作,是國內最早開展中藥(植物藥)I期臨床耐受性和藥代動力學試驗的研究機構。

近20年來,臨床藥理研究所依托國家“十五”、“十一五”、“十二五”GCP平臺建設課題的實施,逐步完善內涵建設,培養了一批專業化、職業化的各類臨床研究人員隊伍,出版了我國第一部中藥臨床藥理學專著,建立了符合國際規范的中藥臨床評價研究技術平臺,在臨床試驗關鍵技術的研究、受試者保護體系的建設、電子化數據管理、質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.

  


臨床藥理所成果展示

Exhibition 

國家重點科研項目

科技部“九五”計劃1035工程

科技部“863”攻關計劃“中藥新藥臨床試驗規范化研究”課題

十五”,國家863計劃“中國臨床試驗關鍵技術及平臺研究”課題

十一五”,國家科技支撐計劃“重大疑難疾病中醫防治研究”項目“中醫臨床研究的方案優化及質量控制研究”課題

科技部科技重大專項“以心血管病為示范的中藥新藥臨床評價研究技術平臺”課題

十二五”,科技部重大專項“重大新藥創制”項目“創新藥物研究開發技術平臺建設”課題

行業專項“中醫慢病臨床科研體系及其成果轉化應用模式研究”、“臨床科研一體化信息平臺建設”

國家中醫藥管理局中醫藥標準化項目“中醫藥臨床診療標準研究推廣基地建設”

北京市中醫藥科技項目“‘樣本量再估計’適應性設計方法在中藥臨床試驗中的探索性研究”

國家自然基金青年科學基金項目“中西醫合作脾胃病醫患共建式循證病歷探索研究”

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


受試者保護體系

2010年6月在北京地區率先通過了WHO FERCAPSIDCER認證

2013年5月通過SIDCER復核檢查

2013年3月通過世界中醫藥學會聯合會中醫藥臨床研究倫理審查平臺評估

已正式申請美國人類醫學研究委員會(AAHRPP)認證

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

     


網絡化臨床試驗數據管理平臺

建立了基于網絡技術的數據管理及采集系統,并于2014年1月成功通過NNIT公司的系統驗證,現已在新藥臨床研究及重大臨床科研項目中應用

目前有22個臨床研究項目(包括70個臨床試驗分中心)應用該系統

數據的采集采用CDISC(Clinical Data Interchange Standards Consortium)標準

參與國家食品藥品監督管理局藥品審評中心臨床試驗電子數據采集EDC技術指導原則的編寫

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

《中醫臨床藥理學》《中藥新藥臨床試驗設計與實施》、《中醫臨床研究實施方案設計與優化》、《中醫臨床研究實施過程質控與管理》、《中藥上市后再評價關鍵技術》、《中藥注射劑臨床應用指南》、《中藥臨床合理應用手冊》、《中成藥臨床合理應用手冊》、《中藥不良反應與合理用藥》

在國家核心期刊發表論文百余篇

國家教育部、中華中醫藥學會和北京市等各級科學技術獎項5項

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