title: Lessons learned from the DIG trial.
abstract: The Digitalis Investigation Group (DIG) trial was the first large simple trial conducted by the National Heart, Lung, and Blood Institute in conjunction with the Department of Veterans Affairs. A large simple trial is a major undertaking. Simplification at the sites requires careful planning and discipline. Lessons learned from the DIG trial were: (1) keep a large simple trial very simple and keep all study procedures very simple; (2) ancillary studies are important and can complement a large simple trial but require careful advanced planning; (3) anticipate special needs when shipping study drugs internationally; (4) regional coordinating centers can be very useful; (5) recruit as many capable sites as possible; (6) provide research-inexperienced sites/investigators with extra help to obtain federalwide assurance statements from the Office for Human Research Protections and institutional review board approvals; (7) adequately reimburse sites for the work completed; (8) maintain investigator enthusiasm; (9) monitor the slow performers and sites with numerous personnel changes; (10) choose an endpoint that is easy to ascertain; (11) keep the trial simple for participants; and (12) plan early for closeout and for activities between the end of the trial and publication of results.
authors.affiliation: National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA. d.a.egan@att.net
authors.forename: Debra
authors.initials: D
authors.lastname: Egan
authors.forename: Nancy
authors.initials: N
authors.lastname: Geller
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.forename: Rekha
authors.initials: R
authors.lastname: Garg
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Collins
authors.forename: James
authors.initials: J
authors.lastname: Mathew
authors.forename: Edward
authors.initials: E
authors.lastname: Philbin
mesh_terms: D002170:Canada; D002316:Cardiotonic Agents / Q000627:therapeutic use; D004077:Digoxin / Q000627:therapeutic use; D006333:Heart Failure / Q000188:drug therapy; D015337:Multicenter Studies as Topic / Q000379:methods*; D009934:Organization and Administration; D015397:Program Evaluation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014481:United States
chemical_list: D002316:Cardiotonic Agents; D004077:Digoxin