药学协调中心在DIG试验中的作用

Controlled clinical trials Pub Date : 2003-12-01 DOI:10.1016/S0197-2456(03)00102-8

Carol L. Fye R.Ph., M.S. , William H. Gagne , Dennis W. Raisch R.Ph., Ph.D. , Mark S. Jones B.S., M.B.A. , Mike R. Sather Ph.D., F.A.S.H.P. , Sandra L. Buchanan , Frances R. Chacon , Rekha Garg M.D., M.S. , Salim Yusuf M.B.B.S., F.R.C.P. , William O. Williford Ph.D. , on behalf of the DIG Investigators

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引用次数: 1

摘要

大型简单试验(LSTs)的出现是为了回应大样本量的需求，以回答治疗对临床终点有中等影响的重要临床问题。1991年至1996年间，国家心脏、肺和血液研究所和退伍军人事务部(VA)合作研究项目进行了一项名为“洋地黄调查小组(DIG):评估洋地黄对心力衰竭死亡率影响的试验”的LST。VA合作研究项目临床研究药学协调中心担任DIG药学协调中心(PCC)。作为参与DIG试验的直接结果，PCC确定需要更加重视计算机化和临床试验的自动化支持，特别是lst。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The role of the pharmacy coordinating center in the DIG trial

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.

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Controlled clinical trials

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