Siegel J N
Division of Clinical Trials Design and Analysis, OTRR, CBER, Food and Drug Administration, Rockville MD, USA.
Lupus. 1999;8(8):581-5. doi: 10.1191/096120399680411425.
To make the process of developing new therapeutic agents more efficient, it is critical that investigators and industry sponsors understand in advance what information they will need to provide to the US Food and Drug Administration (FDA) in order to license and market their product. To facilitate that process, the FDA publishes guidance documents describing current thinking about various issues that arise at all stages of product development. The FDA is currently in the process of formulating a guidance document about clinical development programs for systemic lupus erythematosus (SLE). The goal of this document is to describe some of the types of clinical trials that could be used to demonstrate safety and efficacy of therapeutic agents in SLE.
为提高开发新型治疗药物的效率，研究人员和行业赞助商提前了解为使其产品获得美国食品药品监督管理局（FDA）的许可并上市需要提供哪些信息至关重要。为推动这一进程，FDA发布指导文件，阐述其对产品开发各阶段出现的各类问题的当前看法。FDA目前正在制定一份关于系统性红斑狼疮（SLE）临床开发项目的指导文件。该文件的目标是描述一些可用于证明治疗药物在SLE中的安全性和有效性的临床试验类型。
