The role of the pharmacy coordinating center in the DIG trial

被引：3

作者：

Fye, CL

Gagne, WH

Raisch, DW

Jones, MS

Sather, MR

Buchanan, SL

Chacon, FR

Garg, R

Yusuf, S

Williford, WO

机构：

[1] Clin Res Pharm Coordinat Ctr, VA Cooperat Studies Program, Albuquerque, NM 87106 USA

[2] NHLBI, Bethesda, MD 20892 USA

[3] Eli Lilly & Co, Indianapolis, IN 46285 USA

[4] McMaster Clin, Hamilton, ON, Canada

[5] VA Med Ctr, Cooperat Studies Program Coordinating Ctr, Perry Point, MD USA

[6] Univ Maryland, Dept Epidemiol & Prevent Med, Baltimore, MD 21201 USA

来源：

CONTROLLED CLINICAL TRIALS | 2003年 / 24卷 / 06期

关键词：

large simple trial; randomized clinical trial; digoxin; heart failure; pharmacy coordinating center;

D O I：

10.1016/S0197-2456(03)00102-8

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Large simple trials (LSTs) emerged in response to the need for large sample sizes to answer important clinical questions in which treatments have a moderate effect on clinical endpoints. Between 1991 and 1996 the National Heart, Lung, and Blood Institute and the Department of Veterans Affairs (VA) Cooperative Studies Program conducted an LST entitled "Digitalis Investigation Group (DIG): Trial to Evaluate the Effect of Digitalis on Mortality in Heart Failure." The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center served as the DIG pharmacy coordinating center (PCC). As a direct result of involvement in the DIG trial, the PCC identified the need for an increased emphasis on computerization and automated support of clinical trials, especially LSTs. (C) 2003 Elsevier Inc. All rights reserved.

引用

页码：289S / 297S

页数：9