Playing safe and preserving integrity: Making the FDA model work

Statistics in Medicine

Volumn 23, Issue 10, 2004, Pages 1523-1525

  Wittes, Janet ^a  

^a University of Iowa   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL STUDY; DATA BASE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; MEDICAL DECISION MAKING; MEDICAL INFORMATION; MEDICAL SPECIALIST; MODEL; PROFESSIONAL STANDARD; RESPONSIBILITY; RISK ASSESSMENT; STATISTICAL ANALYSIS;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA INTERPRETATION, STATISTICAL; ETHICS, PROFESSIONAL; GUIDELINES; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 2442715089     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1788     Document Type: Article

References (2)

1. Ellenberg SS, George SL. Susan. Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? Statistics in Medicine 2004; 23:1503-1505.
2. Pitt B, Zannad F, Remme WJ et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. New England Journal of Medicine 1999; 341:709-717.