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临床试验的设计某些疾病的大多数患者,即使未经医生的特殊治疗,亦有自行痊愈的可能。如果缺乏周密的设计和正确的对比,往往容易夸大新药的疗效。有些新药风行一时,但经不住时间的考验,终归淘汰。究其原因,主要是事先未经科学的临床试验。科学的、有对比的临床试验至少应包含以下几点:1.符合已知的医药原理和道德规范;2.将受试者分组时,没有系统误差(偏差),保证了组间的可比性;3.评价疗效时,防止了可能来自医务人员和病人这两方面的主观偏性;4.有足够的例数。统计方法只能帮助我们解决后面三个问题。
Design of Clinical Trials Most patients with certain diseases, even without special medical treatment, may also recover spontaneously. Without careful design and correct comparison, it is often easy to exaggerate the efficacy of new drugs. Some new drugs became popular, but they could not stand the test of time. The reason for this is mainly because there are no scientific clinical trials. Scientific, comparative clinical trials should include at least the following: 1. Complies with known medical principles and ethics; 2. When grouping subjects, there is no systematic error (bias), guaranteeing comparability between groups 3. When assessing efficacy, prevent subjective biases that may come from both medical personnel and patients; 4. There are enough cases. Statistical methods can only help us solve the next three problems.