Regulatory issues for clinical gene therapy trials

被引：14

作者：

Cornetta, K

Smith, FO

机构：

[1] Indiana Univ, Sch Med, Dept Med, Indianapolis, IN 46202 USA

[2] Indiana Univ, Sch Med, Dept Microbiol & Immunol, Indianapolis, IN 46202 USA

[3] Indiana Univ, Sch Med, Dept Med & Mol Genet, Indianapolis, IN 46202 USA

[4] Cincinnati Childrens Hosp Med Ctr, Dept Pediat, Div Hematol Oncol, Cincinnati, OH 45229 USA

[5] Cincinnati Childrens Hosp Med Ctr, Dept Pediat, Div Expt Hematol, Cincinnati, OH 45229 USA

[6] Univ Cincinnati, Coll Med, Cincinnati, OH 45229 USA

来源：

HUMAN GENE THERAPY | 2002年 / 13卷 / 10期

关键词：

D O I：

10.1089/104303402320138925

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 [微生物学]; 0836 [生物工程]; 090102 [作物遗传育种]; 100705 [微生物与生化药学];

摘要：

Gene therapy trials are among the most heavily regulated clinical trials. In this review, the basic tenets of human subject research are discussed in the context of the regulatory bodies which oversee this work. The challenges faced by academic research are outlined, including new and proposed regulations which impact human gene therapy investigators.

引用

页码：1143 / 1149

页数：7