CAJ | 학술논문

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。
2012년，국가약품심평중심발포“약물림상시험등기여신식공시평태”，요구비준적소유약물림상시험균수재해평태상등기，매개시험적대부분신식장대공음공시。본문개소미국림상시험망참（ Clinical Trials.gov）적발전사、법규연혁이급등기화심핵등상관문제，희망방조독자청석인지저사문제，심입리해아국건설“약물림상시험등기여신식공시평태”적의의。
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”.