Access to Patient-Level Data from GlaxoSmithKline Clinical Trials

被引:95
作者
Nisen, Perry [1 ]
Rockhold, Frank [1 ]
机构
[1] GlaxoSmithKline, Res & Dev, King Of Prussia, PA USA
关键词
D O I
10.1056/NEJMsr1302541
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
GlaxoSmithKline is providing access to patient-level clinical trial data under a new policy. This article reviews the data-access plan. Efforts are under way to increase the transparency of clinical trial data. Among the efforts are those being undertaken at GlaxoSmithKline, where we have recently made a commitment to provide access to deidentified patient-level data. We are taking this step because it is the right thing to do, both scientifically and for society, and it is in line with our company's commitment to transparency in clinical trial reporting. As of May 2013, investigators are able to request access to deidentified patient-level data from a subset of GlaxoSmithKline-sponsored clinical trials. We expect that research teams requesting data will have sufficient statistical ...
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收藏
页码:475 / 478
页数:4
相关论文
共 2 条
[1]  
Opinion 4/2007 on the Concept of Personal Data
[2]  
Other Requirements Relating to Uses and Disclosures of Protected Health Information