Weighing the pros and cons for composite outcomes in clinical trials

Journal of Clinical Epidemiology

Volumn 60, Issue 7, 2007, Pages 658-659

  Freemantle, Nick ^a   Calvert, Melanie ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ARTICLE; BINOMIAL DISTRIBUTION; CLINICAL STUDY; COMPOSITE OUTCOME; COST EFFECTIVENESS ANALYSIS; DEATH; DISEASE COURSE; EVIDENCE BASED PRACTICE; METHODOLOGY; OUTCOME ASSESSMENT; OUTCOMES RESEARCH; PRIORITY JOURNAL; RISK ASSESSMENT; STATISTICAL CONCEPTS; STATISTICAL SIGNIFICANCE; SURVIVOR; THERAPY EFFECT; TREATMENT OUTCOME;

EID: 34250016814     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2006.10.024     Document Type: Note

References (5)

1. Freemantle N., Calvert M., Wood J., Eastaugh J., and Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty?. JAMA 289 (2003) 2554
2. Ferreira-Gonzalez I., Permanyer-Miralda G., Busse JW., Bryant D.M., Montori V.M., Alonso-Coello P., et al. Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns. J Clin Epidemiol 60 (2007) 651-657
3. ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials (ICH E9). Stat Med (1999) 1905-1942
4. FDA. Draft guidance for industry. Patient reported outcome measures: use in medical product development to support labeling claims. 2006.
5. Chi G.Y.H. Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol 19 (2005) 609-619