title: The role of the data coordinating center in the DIG trial.
abstract: The Digitalis Investigation Group (DIG) trial was a large simple trial (LST) begun in 1990 as a collaboration between the National Heart, Lung, and Blood Institute and the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP). Its primary objective was to determine whether digitalis had beneficial, harmful, or no effect on total mortality in patients with congestive heart failure and an ejection fraction < or =0.45. The Perry Point VA CSP Coordinating Center served as the trial's data coordinating center (DCC). The DCC was involved in all phases of the study from planning and design, organization and start-up, and patient recruitment and follow-up through closeout, final analyses, and manuscript preparation. While DCC responsibilities for an LST are basically the same as for other multicenter randomized clinical trials, their size and the inclusion of many inexperienced research sites can add a complexity that the DCC must be prepared to handle from the beginning. This paper describes the role of the DCC in the DIG trial.
authors.affiliation: Cooperative Studies Program Coordinating Center, VA Medical Center, Perry Point, Maryland 21902, USA. william.williford@med.va.gov
authors.forename: William O
authors.initials: WO
authors.lastname: Williford
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Collins
authors.forename: Anne
authors.initials: A
authors.lastname: Horney
authors.forename: Gail
authors.initials: G
authors.lastname: Kirk
authors.forename: Frances
authors.initials: F
authors.lastname: McSherry
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Spence
authors.forename: Susan
authors.initials: S
authors.lastname: Stinnett
authors.forename: Cindy L
authors.initials: CL
authors.lastname: Howell
authors.forename: Rekha
authors.initials: R
authors.lastname: Garg
authors.forename: Debra
authors.initials: D
authors.lastname: Egan
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D002170:Canada; D002316:Cardiotonic Agents / Q000627:therapeutic use; D003625:Data Collection / Q000379:methods*; D004077:Digoxin / Q000627:therapeutic use; D006333:Heart Failure / Q000188:drug therapy; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D009934:Organization and Administration; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014481:United States
chemical_list: D002316:Cardiotonic Agents; D004077:Digoxin