药物临床试验信息公开研究

Study on Government Information Disclosure of Drug Clinical Trials

在对政府药物临床试验信息公开现状分析的基础上,根据与公众利益、与申办人利益和公开效益成本比在法理上确定了药物临床试验的公开范围,并建议完善政府信息公开指南、扩大公开范围以及促进申办人主动公开等确保信息公开、公平、便民。

Based on the analysis of current situation of drug clinical trial information disclosure, the range of the disclosure of legal principle were confirmed according to the public and sponsor and benefit--cost ration. Recommendations through the implementa- tion of perfecting the government information openness guideline, expanding the open range and promoting applicants＇ initiative to disclose clinical trial information so as to ensure the openness, fairness and convenience of the information.