论文部分内容阅读
现代临床科学方法学上的最大进展之一是前瞻性的随机对照临床试验。这一研究设计方法,最早由现代统计学之父Fisher于20年代用于农业科学实验,30年代首次将随机化原则引入医学实验中,40年代开始了第一个多中心对照临床试验。1962年,美国FDA要求凡申请审批的新药都必须接受严格的随机对照试验。至此,此方法便广泛用于临床研究。
One of the biggest advances in modern clinical science methodology is prospective randomized controlled clinical trials. This method of research design was first used by Fisher, the father of modern statistics, in agricultural science experiments in the 1920s. For the first time in the 1930s, the randomization principle was introduced into medical experiments. The first multi-center controlled clinical trial was started in the 1940s. In 1962, the U.S. FDA required that all new drugs submitted for approval must undergo a rigorous randomized controlled trial. At this point, this method is widely used in clinical research.