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临床试验中的消费者风险。

The consumer's risk in clinical trials.

作者信息

Kramer B S

机构信息

NCI-Navy Medical Oncology Branch, National Naval Medical Center, Bethesda, MD 20814.

出版信息

Mol Biother. 1990 Sep;2(3):132-6.

PMID:2222896
Abstract

In any formal statistical test of the null hypothesis (the statement that a population parameter is equal to a specific value), there are two possible types of error. Type 1 or alpha error has occurred if the investigator rejects the null hypothesis when it is true. For example, an experimental treatment is declared an advance over standard treatment when it is not. Type 2 or beta error has occurred if the null hypothesis is not rejected when it is false. In this case, the investigator concludes that the experimental treatment is no different than the standard when it actually is. The two types of error can be conceptualized, respectively, as the consumer's risk and the producer's risk. In many reports of clinical trial methodology, it is the producer's risk that is emphasized. It is understandable why producer's risk would be of concern to authors of clinical studies. There are, however, numerous potential sources of consumer's risk. It is the latter type of risk that is the primary subject of this report.

摘要

在对原假设(即总体参数等于特定值的陈述)进行的任何形式的统计检验中,存在两种可能的错误类型。如果研究者在原假设为真时拒绝了原假设,就发生了I型错误或α错误。例如,一种实验性治疗方法在实际上并无优势时却被宣称优于标准治疗方法。如果原假设为假时未被拒绝,就发生了II型错误或β错误。在这种情况下,研究者得出实验性治疗方法与标准治疗方法没有差异的结论,而实际上它们是有差异的。这两种错误类型可以分别被概念化为消费者风险和生产者风险。在许多临床试验方法学报告中,强调的是生产者风险。临床研究的作者关注生产者风险是可以理解的。然而,消费者风险有许多潜在来源。本报告的主要主题正是后一种风险类型。

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