Design and conduct of clinical trials: Report of the clinical trials subcommittee of the international Dry Eye WorkShop (2007)

被引：0

作者：

Tsubota, Kazuo ^{[1
]}

Asbell, Penny ^{[1
]}

Dogru, Murat ^{[1
]}

Form, Desmond ^{[1
]}

Foulks, Gary ^{[1
]}

Schaumberg, Debra ^{[1
]}

Schein, Oliver ^{[1
]}

Watanabe, Hitoshi ^{[1
]}

机构：

[1] Keio Univ, Sch Med, Shinjuku Ku, Tokyo 1608582, Japan

来源：

OCULAR SURFACE | 2007年 / 5卷 / 02期

关键词：

clinical trials; DEWS; dry eye; dry eye WorkShop;

D O I：

暂无

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

This report summarizes some universal concepts with regard to clinical trials in general and other issues pertaining to clinical trials specifically tailored to the study of therapeutic intervention in dry eye disease. The report also makes recommendations for logistical design and implementation of such trials. It identifies peculiarities of dry eye disease that complicate clinical trial design, such as the lack of correlation of signs and symptoms, as well as the likelihood of control interventions having a lubricant (placebo) effect. Strategies for environmental trials and controlled adverse environment trials are reviewed.

引用

页码：153 / 162

页数：10

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