The role of the data coordinating center in the DIG trial

Controlled Clinical Trials

Volumn 24, Issue 6 SUPPL., 2003, Pages S277-S288

  Williford, William O ^a,b,f   Collins, Joseph F ^a,b   Horney, Anne ^a   Kirk, Gail ^a   McSherry, Frances ^a   Spence, Elizabeth ^a   Stinnett, Susan ^a   Howell, Cindy L ^a   Garg, Rekha ^c,d   Egan, Debra ^d   Yusuf, Salim ^e  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b UNIVERSITY OF MARYLAND   (United States)

^c ELI LILLY AND COMPANY   (United States)

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

^e HAMILTON GENERAL HOSPITAL   (Canada)

^f DEPARTMENT OF VETERANS AFFAIRS   (United States)

Author keywords

Data coordinating center; Digoxin; Heart failure; Large simple trial; Randomized clinical trial

Indexed keywords

DIGITALIS;

CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DRUG EFFICACY; DRUG SAFETY; HEART VENTRICLE EJECTION; HUMAN; MEDICAL RESEARCH; MORTALITY; ORGANIZATION; REVIEW; SUPPORT GROUP;

EID: 10744228784     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(03)00103-X     Document Type: Article

References (7)

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2. Yusuf S., Held P., Teo K., Toretsky E.R. Selection of patients for randomized controlled trials: implications of wide narrow eligibility criteria. Stat Med. 9:1990;73-86.
3. 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.
4. Jelliffe R.W., Brooker G. Nomogram for digoxin therapy. Am J Med. 57:1974;63-68.
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. 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.