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1、,T,目 录 CONTENTS,01,Who developed it first?,02,What is the nature of RCT?,03,What is the process of RCT?,04,What is the definition of RCT?,Randomized controlled trial (RCT) is a means of testing the effect of a certain therapy or drug in medical and health services, and is especially commonly used in
2、 medicine, biology, and agronomy.,随机对照试验(randomized controlled trail, RCT) 指采用随机分配的方法，将符合要求的研究对象分别分配到试验组和对照组，然后接受相应的人为干预措施，在一致的条件下或相同的环境里，同步进行研究和观察试验效应，并采用客观的、公认的效应指标对试验结果进行测量和评价的试验设计。,Founding The first RCT in the world was organized and implemented by the British Medical Research Association in 19
3、48, which verified the efficacy of streptomycin in the treatment of tuberculosis.,In 1967, Schwartz and Lellouch first proposed that clinical trials had two completely different attitudes, the difference between practicality and explanatory attitudes, which did not attract peoples attention at that
4、time.,Part .02,谁首先发现了RCT?,The first is the apparent randomness caused by the existence of ambiguous variables. After taking into account all variables, the so-called randomness is actually knowable.,The second is that even if you hold all the variables, the outcome is still unknowable, in other word
5、s, there is no absolute cause and effect, the exact same cause will lead to different consequences, and you can only predict the probability of different outcomes.,两种形式 随机对照试验已被国际上公认为临床防治性 研究方法的金标准，主要有两种设计形式:解释性随机 对照试验(explanatory randomized controlled trials, explanatory clinical trials)和实用性随机对照试验
6、(pragmatic randomized controlled trials, pragmatic clinical trials)。,思考研究本质是 “解释性的 ”还是 “实用性的 ”是一个重要的里程碑。 解释性试验竭力探寻一项治疗效应是否存在，干预是如何起到治疗效果的，对明确有效的机制具有较高价值，但很少能告诉我们结论能否推广到更宽的现实环境中及更宽范围的不同人群中。,实用性试验则是在临床实际中的不同治疗方案中比较，朝向提供最佳治疗决策。实用性研究更关心在真实条件下治疗病人的效果怎么样，很少洞察为什么能治疗或怎么样治疗。,Part .04,What is the process of RCT?,Part .04,What is the process of RCT?,RCT的基本程序,1.严格的评价治疗方案的试验和随机对照双盲试验主要是采用随机对照试验(Randomized controlled trial)，也称对照临床试验(controlled clinical trial)，即将研究对象按随机化的方法分为试验组与对照组。,2.试验组给予治疗措施，对照组不给予欲评价的措施，即给予安慰剂(placebo)，前瞻性观察两组转归结局的差别。,Part .04,Part .04,RCT的基本程序,感谢您的观看,
