Lessons learned from the DIG trial

Controlled Clinical Trials

Volumn 24, Issue 6 SUPPL., 2003, Pages S316-S326

  Egan, Debra ^a,i   Geller, Nancy ^a   Yusuf, Salim ^b   Garg, Rekha ^a,c   Collins, Joseph F ^d,e   Mathew, James ^f,g   Philbin, Edward ^h  

^a NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^b HAMILTON GENERAL HOSPITAL   (Canada)

^c ELI LILLY AND COMPANY   (United States)

^d DEPARTMENT OF VETERANS AFFAIRS   (United States)

^e UNIVERSITY OF MARYLAND   (United States)

^f UNIVERSITY OF IOWA   (United States)

^g Wisconsin Heart and Vascular Clinics   (United States)

^h ALBANY MEDICAL COLLEGE   (United States)

ⁱ NONE   (United States)

Author keywords

Clinical trial organizational structures; Digitalis; Large simple trial; Lessons learned; Trial conduct

Indexed keywords

DIGITALIS;

ARTICLE; CLINICAL TRIAL; HEART FAILURE; HUMAN; METHODOLOGY; ORGANIZATION; PATIENT RIGHT; PLANNING; SAFETY;

EID: 0344983400     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(03)00099-0     Document Type: Article

References (10)

1. The Digitalis Investigation Group. Rationale, design, implementation and baseline characteristics of patients in the DIG trial: a large, simple trial to evaluate the effect of digitalis on mortality in heart failure. Control Clin Trials. 17:1996;77-97.
2. The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 336:1997;525-533.
3. Yusuf S., Collins R., Peto R. Why do we need some large simple randomized trials? Stat Med. 3:1984;409-420.
4. Williford W.O., Collins J.F., Horney A., et al. The role of the data coordinating center in the DIG trial. Control Clin Trials. 24:2003;277S-288S.
5. Fye C.L., Gagne W.H., Raisch D.W., et al. The role of the pharmacy coordinating center in the DIG trial. Control Clin Trials. 24:2003;289S-297S.
6. Collins J.F., Martin S., Kent E., et al. The use of regional coordinating centers in large clinical trials: the DIG trial. Control Clin Trials. 24:2003;298S-305S.
7. Jeliffe R.W., Brooker G.A. Nomogram for digoxin therapy. Am J Med. 57:1974;63-68.
8. U.S. Dept. of Health and Human Services. Federalwide assurance of protection for human subjects. January 10, 2001.
9. U.S. Dept. of Health and Human Services. Institutional review board/independent ethics committee registration. April 2001.
10. Collins J.F., Garg R., Teo K.K., Williford W.O., Howell C.L. The role of the data coordinating center in the IRB review and approval process: the DIG trial experience. Control Clin Trials. 24:2003;306S-315S.