【作者】 武小军；

【导师】 孙鹤；

【作者基本信息】 天津大学 ， 药事管理， 2009， 硕士

【摘要】 药物临床试验(Clinical Trial)是药品研发在临床方面的具体表现,是药品从研发到应用不可或缺的重要环节。作为一个高度专业化的领域,药物临床试验参与各方包括申办者、研究者、伦理委员会、合同研究组织(CRO)以及监管部门必须执行《药物临床试验质量管理规范》(GCP)及其他有关法律法规,所有活动均应该纳入到政府的监管范畴中。针对2002年以来的低水平重复申报、研发秩序混乱甚至试验数据造假的情形,始于2006年7月的全国药品注册核查行动,暴露出临床试验的监管尚存在很多问题,对临床试验的监管亟待加强。本文运用法律法规梳理、文献研究、案例分析等非接触式研究方法,结合实地调研和专家访谈等接触式研究方法,对我国GCP与药物临床试验监管的历史、当前监管体系存在的主要问题、以及美国FDA的临床试验监管方式进行了深入研究。全文首先总结了国内外药物临床试验监管的历史与概况,将世界药物临床试验管理的发展历程分为三个阶段,梳理了我国药物临床试验监管的历史,并将我国现行GCP与ICH GCP在细则上进行了对比,接着梳理了我国药物临床试验监管的框架及现状。然后全面分析了我国药物临床试验监管中存在的主要问题,包括:(1)监管体系不完善,主要涉及监管主体混乱,伦理委员会运作缺乏监管以及现场核查标准较低;(2)药物临床试验机构数量不足,并且发展不平衡;(3)临床试验备案制度执行不畅,试验实施过程监管缺失;(4)SOP的实施有待提高;(5)受试者的损害补偿机制不完善等。最后,借鉴美国FDA的监管理念和方法,针对上述研究发现的问题,对我国未来临床试验的监管提出以下建议:(1)完善临床试验监管体系、明确监管部门的职能分工;(2)SFDA等相关部门定期评估与实时监督GCP的执行情况;(3)加强对伦理委员会的管理和监督;(4)指导临床试验机构建设、满足新药临床试验需求;(5)提高临床试验监管的公开和透明度等。更多还原

【Abstract】 Clinical trial is a key procedure in the new drug research and development process. As a highly specialized area, the involved parties in clinical trials, including sponsors, investigators, ethics committees, contract research organizations (CRO) and regulatory agencies, need to implement "Good Clinical Practice" (GCP) and other relevant laws and regulations, and all of activities should be integrated into areas of government supervision. Several problems are revealed through the Special Registration Inspection Action by SFDA from July 2006 to December 2007, and the supervision for clinical trials should be strengthened.In this paper, research methods including literature search, case studies and field research and interviews with experts have been used to study on China GCP, the regulatory history of clinical trials, major problems in the current regulatory system, as well as U.S. FDA regulation of clinical trials.In this work, the domestic and international regulations of drug clinical trials are first summed up. Then China GCP and ICH GCP are compared in the details. By analyzing China’s regulatory framework of clinical trials, major problems in the supervision for clinical trials are concluded, including: (1) imperfect regulatory system, such as the regulatory agencies confused, lack of regulating for ethics committees, as well as poor site-inspection standards; (2) lack of the drug clinical trials institutions (certificated hospitals); (3) lack of supervision for the conducting of clinical trials with poor filing system; (4) SOP implementation need to be improved; (5) lack of compensation mechanism to subjects who are damaged in the trials.At last, through drawing on the regulatory experience of U.S. FDA, suggestions on supervision for clinical trials in China have been put forward as follows: (1) improve the regulatory system of clinical trials, and clearly allocate the functions of regulatory agencies; (2) real-time monitoring and regular evaluating of the implementation of GCP should be conducted by SFDA and other related agencies; (3) strengthen management and regulating of the ethics committee; (4) approve more clinical trials institutions, to meet the demand for clinical trials of new drugs; (5) improve the transparent of supervision for clinical trials.更多还原