Lessons learned from the DIG trial

Control Clin Trials. 2003 Dec;24(6 Suppl):316S-326S. doi: 10.1016/s0197-2456(03)00099-0.


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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Canada
  • Cardiotonic Agents / therapeutic use
  • Digoxin / therapeutic use
  • Heart Failure / drug therapy
  • Multicenter Studies as Topic / methods*
  • Organization and Administration*
  • Program Evaluation
  • Randomized Controlled Trials as Topic / methods*
  • United States


  • Cardiotonic Agents
  • Digoxin