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疫苗临床试验主要用于健康个体,大部分用于儿童,具有受试者人数多,试验场地大,疫苗冷链管理要求高等特殊性。国家食品药品监督管理局按照2007年10月开始实施的《药品注册管理办法》,于2009年开始对新申请承担疫苗临床试验的疾病控制中心实施临床试验现场核查。文中对在疫苗临床研究过程中应注意的有关问题进行探讨,为试验机构疫苗临床试验的规范化操作提供参考。
Vaccine clinical trials are mainly used for healthy individuals, most of them for children, with a large number of subjects, large test sites, vaccine cold chain management of higher specificity. In 2009, the State Food and Drug Administration started the field trial of clinical trials on the Centers for Disease Control and Prevention that applied for clinical trials of vaccines in accordance with the Measures for the Administration of Drug Registration, which began in October 2007. This article discusses the relevant issues that should be noticed in the course of vaccine clinical research, and provides references for the standardization of vaccine clinical trials in pilot institutions.