我国药物临床试验伦理审查能力建设发展趋势

我国药物临床试验的深入广泛开展,促进了药物临床试验伦理审查水平的提高,伦理审查能力建设也取得了长足进步。但我国药物临床试验伦理审查能力建设面临系统的评估标准及体系、持续性培训和信息化程度缺乏等问题。加强药物临床试验伦理审查能力建设是我国医药领域进一步推进的重要工作,也是继续探索研究的热点内容及医学伦理审查工作者的自身需求。

The development trendency of capacity development of ethical review of drug clinical trial in China

With the development of the clinical trial being carried out widely in our country,the reviewing capacity and its construction ability of drug clinical trial are also growing.However,problems still exist in fields of evaluation criteria,system,continuous training and informatization.As a result,the construction of promoting the ethical reviewing capacity in drug clinical trials becomes an important task and focus of the further study,as well as the need of EC members.