Powers John H
Science Applications International Corporation (SAIC) in support of the Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.
Clin Infect Dis. 2007 Sep 1;45 Suppl 2:S153-62. doi: 10.1086/519253.
In the United States, drug sponsors must obtain approval from the US Food and Drug Administration before licensure and widespread clinical use of drugs. In this article, I discuss the definition and history of the regulatory requirement for "substantial evidence" of effectiveness from "adequate and well-controlled" clinical trials of drugs. These requirements apply to antimicrobials as they do to other therapeutic drug classes, and they may be even more important in their application to antimicrobials, given issues of antimicrobial resistance. I will discuss the evidence requirements, using examples from clinical trials in diseases such as acute otitis media, acute bacterial sinusitis, and acute exacerbations of chronic bronchitis. Examination of the principles of substantial evidence also points to opportunities to improve the efficiency of confirmatory clinical trials of antimicrobials to obtain more clinically relevant and useful information without increasing the uncertainty regarding the safety and efficacy of these drugs.
在美国，药品申办者在药品获得许可并广泛临床使用之前，必须获得美国食品药品监督管理局的批准。在本文中，我将讨论来自药品“充分且严格对照”临床试验的有效性“充分证据”监管要求的定义和历史。这些要求适用于抗菌药物，如同它们适用于其他治疗药物类别一样，鉴于抗菌药物耐药性问题，这些要求在应用于抗菌药物时可能更为重要。我将通过急性中耳炎、急性细菌性鼻窦炎和慢性支气管炎急性加重等疾病的临床试验实例来讨论证据要求。对充分证据原则的审视还指出了提高抗菌药物确证性临床试验效率的机会，以便在不增加这些药物安全性和有效性不确定性的情况下获得更多临床相关且有用的信息。
