Norrby S R
Department of Infectious Diseases, Lund University Hospital, Sweden.
Eur J Clin Microbiol Infect Dis. 1990 Jul;9(7):523-9. doi: 10.1007/BF01964296.
Clinical trials to test antibiotics are normally of a less than satisfactory quality. Examples of common errors in the design and execution of trials with antibiotics are inclusion of too few patients to allow conclusions to be drawn, open uncontrolled design leading to a risk of considerable investigator bias, and inclusion of heterogeneous patient samples. This article suggests minimum requirements for antibiotic studies. Guidelines for such trials are needed and should have the widest possible international application in order to permit studies involving centres in various countries and to reduce the costs for development of new drugs.
测试抗生素的临床试验质量通常不尽如人意。抗生素试验在设计和实施过程中常见的错误包括：纳入的患者过少，无法得出结论；采用开放的非对照设计，导致存在相当大的研究者偏倚风险；纳入的患者样本具有异质性。本文提出了抗生素研究的最低要求。需要此类试验的指南，并且这些指南应具有尽可能广泛的国际适用性，以便开展涉及不同国家中心的研究，并降低新药研发成本。
