美国临床试验注册与结果公开制度研究

The US clinical trial registration and result disclosure

文中全面研究了美国临床试验注册与结果公开制度的背景、详细政策及其实施效果。美国以立法的形式,要求临床试验在实施之前进行基本信息的注册并及时公开,并在试验结束后公开试验结果信息,经过多年的摸索与实践已取得显著的成效。借鉴美国的成功经验,我国可以从完善立法确立临床试验注册制度、加大医药监管部门的参与力度和建立临床试验先注册后发表机制等方面加强我国药物临床试验信息披露。

Beside with the background,we comprehensively studied the policies and the impact of the US clinical trial registration,and the result disclosure policies.The US clinical trial is enforced to register by the law.Furthermore,its information and result are required to public on time.After several years＇ enforcement,it had achieved certain efficacy.China should draw the successful experiences from US to improve the status of the disclosure of clinical trial information,such as enforcing the clinical trial registration,enlarging the clinical trial administration power,establishing some policies to guide the clinical trial papers published only after its registration.