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The role of the pharmacy coordinating center in the DIG trial

Authors
Journal
Controlled Clinical Trials
0197-2456
Publisher
Elsevier
Publication Date
Volume
24
Issue
6
Identifiers
DOI: 10.1016/s0197-2456(03)00102-8
Keywords
  • Original Article
Disciplines
  • Pharmacology

Abstract

Abstract 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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