临床试验与临床试验中心

Clinical trials and clinical trial unit

临床试验指的是在人体进行的药物或其他干预措施的研究,其目的是确定试验用药品或其他干预措施的疗效与安全性。由于其对象是人,试验中不可避免地涉及社会、心理、伦理和可行性等复杂问题。世界各国已共同认识到必须推行规范化的临床试验,才能保证研究工作的客观、科学和高效。其核心问题就是:既要考虑到以人为对象的特殊性与复杂性,又要保证实验研究的科学性。根据临床科研设计的要求,临床试验应遵循随机化、设立对照、盲法、符合伦理道德等原则。中国临床试验存在的问题是:存在发表偏倚,中国的临床试验尤其是中医药领域的试验得不到国际承认,中国缺乏国际认可的临床试验中心,在随机临床试验的设计、进行、管理和监测、报告等方面存在问题,临床试验的技术方法与质量有待提高。中国循证医学中心正对以往的中文医学文献进行手工检索以建立临床试验数据库,为系统评价和卫生技术评估奠定基础。我国临床研究的水平尚有待提高,应尽可能采用随机对照实验或双盲设计,多中心、大规模的协作研究值得提倡。介绍临床试验的定义和特点、中国临床试验发展的历史、药物临床试验的分期、临床试验管理规范、临床试验研究存在的问题和注意事项等。还介绍了临床试验中心的定义、背景、目标与任务和提供的服务。

These trials involved unavoidably i n some complicated problems such as s o-ciety,psychology,ethics and feasibility.Peoples all over the world have realized that we must do standard clinical trials to ensure that the resea rches are objective,scientific and high e fficiency.The primary problem is th at not any we must think of it' s particularity and complexity when human being is research object,but also we must ensure the research is scientific.Ac-cording to the requirement of clinic al research design,we should abide b y four principles in clinical trials.Those are random,control,blind and being in line with ethics.There are some pr oblems in Chinese clinical trials,s uch as publishing bias,Chinese clinical trials especially in Chinese trade medicine and herbs not being accepte d,lack of approved clinical trial un it(CTU)in China,problems in the designing,carrying out,management,monitoring and reporting of randomi zed control trials(RCTs ).The methods and quality of clinical trials shoul d be improved.Published Chinese med ical literatures were hand-searched to s et up clinical trials database.It is the foundation of systematic review and health technology assessment.The l evel of clinical trial in China should be i mproved.We should use RCTs or dou-ble-blind design.We advocate multi-center and large cooperation resea rch.This article introduced the concept and characteristic of clinical tria l(CT),history of Chinese clinical trial,p hase of pharmacy clinical trial,GCP and problems and announcements of clini cal trial.CT is a kind of researches about pharmacy or other interventio ns in human body to certain the effect s and security of trial pharmacy or oth er interventions.Author introduce d definition,background,aim,duty a nd service of CTU.