Gilbert D N, Beam T R, Kunin C M
Providence Medical Center, Portland, Oregon 97213.
Rev Infect Dis. 1991 Sep-Oct;13 Suppl 10:S890-4. doi: 10.1093/clinids/13.supplement_10.s890.
This article describes the current collaborative effort of the U.S. Food and Drug Administration and the Infectious Diseases Society of America to generate new general and disease/organism-specific guidelines for the evaluation of anti-infective agents. The description includes examples of proposed changes from draft documents. If approved and implemented, the envisioned changes should enable investigators and sponsors to improve the quality of clinical trials of anti-infective drugs. The ultimate goal is to provide physicians with the best information about new drugs and thus to enhance the care of patients with infectious diseases.
本文介绍了美国食品药品监督管理局和美国传染病学会当前为制定抗感染药物评估的新通用指南以及针对特定疾病/病原体的指南所开展的合作努力。描述内容包括来自文件草案的拟议更改示例。如果获得批准并实施，预想中的更改应能使研究人员和申办者提高抗感染药物临床试验的质量。最终目标是为医生提供有关新药的最佳信息，从而加强对传染病患者的护理。
