Carvedilol and the food and drug administration-approval process: A brief response to professor Moye's article

Controlled Clinical Trials

Volumn 20, Issue 1, 1999, Pages 50-51

  Fisher, L D ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Advisory committee; Alpha blocker; Antioxidant; Beta blocker; Carvedilol; FDA; Randomized clinical trial

Indexed keywords

CARVEDILOL;

CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; MORTALITY; PUBLICATION; SHORT SURVEY;

EID: 0033011503     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(98)00050-6     Document Type: Article

References (3)

1. M Packer M.R Bristow J.M Cohn The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group N Engl J Med 334 1996 1349 1355
2. L Moyé Endpoint interpretation in clinical trials the case for discipline Controlled Clin Trials 20 1999 40 49
3. L.D Fisher Carvedilol and the FDA approval process the FDA paradigm and reflections upon hypothesis testing Controlled Clin Trials 20 1999 16 39