Gilbert D N, Beam T R, Kunin C M
Providence Medical Center, Portland, Oregon 97213.
Eur J Clin Microbiol Infect Dis. 1990 Jul;9(7):552-8. doi: 10.1007/BF01964302.
This article summarizes the current collaborative effort between the US Food und Drug Administration and the Infectious Diseases Society of America for the purpose of generating new General and Disease/Organism Specific Guidelines for the evaluation of anti-infective agents. Examples of proposed changes from draft documents are presented. The final documents may assist European colleagues in their efforts to establish a standardized new drug registration process by 1992. An area of mutual interest is the acceptability of safety and efficacy data from international clinical trials. In the interest of human and financial economies, both US and European Guidelines need to clarify the conditions, or criteria, for the conduct of valid 'off-shore' clinical trials.
本文总结了美国食品药品监督管理局与美国传染病学会目前的合作成果，旨在制定新的抗感染药物评估通用指南以及针对特定疾病/病原体的指南。文中列举了文件草案中提议的一些修改内容。最终文件可能会帮助欧洲同行在1992年前建立标准化的新药注册流程。一个共同关注的领域是国际临床试验安全性和有效性数据的可接受性。出于人力和财力节约的考虑，美国和欧洲的指南都需要明确开展有效“境外”临床试验的条件或标准。
