1 大规模多中心临床试验基本概念 大规模多中心临床试验是指由多个医疗中心参加的大样本(一般为千例以上)临床试验。大规模多中心临床试验常见有以下两种情况:一种是新药临床试验,另一种是大样本随机临床试验。两者相同点是均评估某种治疗措施的临床效果,但有许多不同之处。Ⅱ、Ⅲ期新药临床试验是药品生产厂家为新药注册所进行的为药品法规定的必不可少的临床试验过程,主要目的是评估该药的一般临床疗效及药物不良反应。大样本随机临床试验是医疗科研人员发起的为解决医学领域某些尚待解决的重要问题进行的临床研究,主要目的是评估某种治疗措施对患者生存率及重要临床事件的影响,见表1。 A large-scale multi-center clinical trial Basic concepts Large-scale multicenter clinical trial is a large sample (usually more than a thousand cases) of clinical trials attended by multiple medical centers. Large-scale multicenter clinical trials are common in the following two cases: one is a new drug clinical trials, and the other is a large sample of randomized clinical trials. The similarity between the two is to evaluate the clinical effect of some treatment, but there are many differences. Ⅱ, Ⅲ clinical trials of new drugs is a drug manufacturer for the registration of new drugs for drug law provides the essential clinical trial process, the main purpose is to evaluate the general clinical efficacy of the drug and adverse drug reactions. Large sample of randomized clinical trials is initiated by medical researchers to solve some important medical problems in the field of clinical research, the main purpose is to assess the impact of a treatment on patient survival and important clinical events, as shown in Table 1 .