摘要
2012年,国家药品审评中心发布"药物临床试验登记与信息公示平台",要求批准的所有药物临床试验均需在该平台上登记,每个试验的大部分信息将对公众公示。本文介绍美国临床试验网站(Clinical Trials.gov)的发展史、法规沿革以及登记和审核等相关问题,希望帮助读者清晰认知这些问题,深入理解我国建设"药物临床试验登记与信息公示平台"的意义。
Center for Drug Evaluation addressed “Platform for Registry and Publicity of Drug Clinical Trials” in 2012 , which requested all drug clinical trials be registered on it and majority of information of every trial be available publicly.This article introduces the issues about history , re-form on laws and regulations , registration and review of American clinical trial website （ ClinicalTrials.gov ） , and the aim is to help readers under-stand these issues and comprehend the significance of “Platform for Reg-istry and Publicity of Drug Clinical Trials”.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2014年第8期750-752,共3页
The Chinese Journal of Clinical Pharmacology
关键词
临床试验公示
药物临床试验登记与信息公示平台
美国临床试验网站
clinical trials publicity
Platform for Registry and Publicity of Drug Clinical Trials
American clinical trial website
