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首都医科大学附属北京天坛医院

机构简介

药物临床试验机构简介

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首都医科大学附属北京天坛医院药物临床试验机构简介

      首都医科大学附属北京天坛医院是一所以神经病学为重点的三级甲等综合性医院,为中国医学科学院神经科学研究所的所在单位。我院药物临床试验机构成立于1997年,2004年后经国家食品药品监督管理局(NMPA)批准更名为北京天坛医院国家药物临床试验机构(以下简称机构)。到目前为止,我院被NMPA认证的专业共计14个(包括神经内科神经外科、心血管、内分泌、消化、麻醉、医学影像(诊断)、妇产、普通外科骨科、呼吸科、重症医学、急诊医学(感染性疾病、心脑血管疾病)、儿科(小儿神经外科)),可以承担I期-IV期药物临床试验,以及器械类临床试验。另外我院于2017年10月重建了I期临床研究室,现有病床50张,可进行创新药I期临床试验的设计、实施和报告。2018年NMPA对我院机构再次进行复审,同时我院还完成了医疗器械临床试验机构的备案工作。

      医院的医疗设备先进,每年收治许多来自北京市及全国各地的患者,为药物临床试验提供了充足的病源条件。我院机构设立了药物临床试验机构办公室,建立了与药物临床试验相应的管理制度、设计规范和标准操作规程,我院承担各项药品、生物制品或器械试验的主要研究者均为具有副高以上职称的医务人员,具有丰富的临床经验及临床试验经验,管理人员和专业技术人员全部接受了药物临床试验技术和GCP知识的培训,按照GCP要求开展药物临床试验。医院具有完备的临床新药科研基础设施和技术条件,具备开展药物临床试验的团队和支撑条件,以保证药物临床试验的质量。

      医院于2013年8月获得批准,正式成立“国家神经系统疾病临床医学研究中心”,该中心是国家深化医疗体制改革、落实《医学科技发展“十二五”规划》的重大举措,也是科技部和国家卫生计生委为加强医学科学创新体系建设,提升临床研究能力而打造的神经系统疾病临床医学与转化研究的高地,具体负责推动全国的神经系统疾病临床研究和新技术、新方法的转化工作。

      我院医学伦理委员会于2010年申请并获得了SIDCER/FERCAP伦理委员会认证。通过与国际的接轨,规范了伦理委员会的工作流程、程序,实行主审委员负责制,并于2013年通过了三年复核检查,保障了药物临床试验伦理审查的水平和质量。近期详情请参见北京天坛医院官网的医学伦理委员会板块。

  地址:北京市丰台区南四环西路119号

  邮编:100070

  联系人: 王佳庆、赵伟伟

  联系电话:010-59975527 010-59975178 

 





Brief Introduction of the Institution

      Beijing Tiantan Hospital, affiliated to Capital Medical University, is a tertiary comprehensive hospital with a focus on neurology. It is the unit of the Institute of Neuroscience of the Chinese Academy of Medical Sciences. The drug clinical trial institution of our hospital was established in 1997. After 2004, it was renamed as the National Drug Clinical Trial Institute (hereinafter referred to as the institution) of Beijing Tiantan Hospital by the State Food and Drug Administration (NMPA). So far, our school has been certified by NMPA for a total of 14 (including neurology, neurosurgery, cardiovascular, endocrine, digestive, anesthesia, medical imaging (diagnosis), maternity, general surgery, orthopedics, respiratory, critical care Emergency medicine (infectious diseases, cardiovascular and cerebrovascular diseases), pediatrics (pediatric neurosurgery), can undertake Phase I-IV drug clinical trials, as well as device-based clinical trials. In addition, our hospital rebuilt the Phase I clinical laboratory in October 2017, with 50 existing beds, which can be used for the design, implementation and reporting of Phase I clinical trials of innovative drugs. In 2018, NMPA reviewed the institution again, and the hospital also completed the filing of the medical device clinical testing organization.

      The hospital's medical equipment is advanced, and many patients from Beijing and all over the country are admitted every year, providing sufficient source conditions for drug clinical trials. Our institution has set up a drug clinical trial agency office, established a management system, design specifications and standard operating procedures corresponding to drug clinical trials. The main investigators of our hospitals for testing various drugs, biological products or devices all have subtropical highs. The medical staff with the above titles has rich clinical experience and clinical trial experience. The management personnel and professional technicians have all received the training of drug clinical trial technology and GCP knowledge, and carried out drug clinical trials in accordance with GCP requirements. The hospital has complete clinical and new drug research infrastructure and technical conditions, and has the team and supporting conditions for conducting drug clinical trials to ensure the quality of clinical trials.

      The hospital was approved in August 2013 and formally established the “National Center for Clinical Medical Research of Nervous System Diseases”, which is a major measure for the country to deepen the reform of the medical system and implement the “Twelfth Five-Year Plan for Medical Science and Technology Development”. And the National Health and Family Planning Commission to strengthen the medical science innovation system to enhance the clinical research capabilities to create a high-level clinical and translational research of neurological diseases, specifically responsible for promoting the national clinical research of neurological diseases and the transformation of new technologies and methods.

      Our Medical Ethics Committee applied for and obtained the SIDCER/FERCAP Ethics Committee certification in 2010. Through the integration with the international, the ethics committee's work flow and procedures were standardized, and the chief audit committee responsibility system was implemented. In 2013, it passed the three-year review and inspection, which guaranteed the level and quality of the drug clinical trial ethical review. For more details, please refer to the Medical Ethics Committee section of the official website of Beijing Tiantan Hospital.