Katz Russell
Division of Neuropharmacological Drug Products, United States Food and Drug Administration, Rockville, Maryland 20852, USA.
NeuroRx. 2004 Jul;1(3):307-16. doi: 10.1602/neurorx.1.3.307.
The United States Food and Drug Administration is charged with approving drug treatments that have been shown to be safe and effective. Relevant statutes and regulations provide a legal framework for establishing safety and effectiveness that is sufficiently flexible to ensure that appropriate scientific data are collected for specific treatments targeted to particular diseases. Nonetheless, all clinical trials proposed to establish effectiveness must incorporate common elements in order for the appropriate legal and scientific standards of drug approval to be met. This article will discuss the relevant laws and regulations pertaining to the current effectiveness standard and will discuss the most important clinical trial design elements currently considered acceptable for applications for treatments of neurologic and psychiatric illness.
美国食品药品监督管理局负责批准已证明安全有效的药物治疗方法。相关法规提供了一个建立安全性和有效性的法律框架，该框架具有足够的灵活性，以确保针对特定疾病的特定治疗方法收集到适当的科学数据。尽管如此，所有为证明有效性而提议进行的临床试验都必须包含共同要素，以便符合药物批准的适当法律和科学标准。本文将讨论与当前有效性标准相关的法律法规，并讨论目前被认为适用于神经和精神疾病治疗申请的最重要的临床试验设计要素。
