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.
Fye
Carol L
CL
Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, VA Medical Center, Albuquerque, New Mexico 87106-4180, USA. carol.fye@csp.research.med.va.gov
Gagne
William H
WH
Raisch
Dennis W
DW
Jones
Mark S
MS
Sather
Mike R
MR
Buchanan
Sandra L
SL
Chacon
Frances R
FR
Garg
Rekha
R
Yusuf
Salim
S
Williford
William O
WO
D002170:Canada; D002316:Cardiotonic Agents / Q000627:therapeutic use; D004077:Digoxin / Q000627:therapeutic use; D004349:Drug Packaging; D006333:Heart Failure / Q000188:drug therapy; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D010593:Pharmaceutical Services / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014481:United States
D002316:Cardiotonic Agents; D004077:Digoxin