Document Detail

Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities.
MedLine Citation:
PMID:  12812814     Owner:  NLM     Status:  MEDLINE    
Although federal initiatives have mandated broader inclusion of minorities in clinical research on diseases that have disparities in health by race and ethnicity, it is not clear whether these initiatives have affected reporting of trial results. The objective of this study was to examine the reporting of race/ethnicity in clinical trials reports in areas of known disparities in health (i.e., diabetes, cardiovascular disease, HIV/AIDS, and cancer) and to determine what factors were associated with reporting of race/ethnicity in results. We performed a Medline search covering the period January 1989 to Oct 2000 to identify clinical trials of diabetes, cardiovascular disease, HIV/AIDS, and cancer published in the Annals of Internal Medicine, JAMA, and New England Journal of Medicine. The main outcome measure was the reporting of participation and of results by race/ethnicity of trial participants. Of 253 eligible trials, 40% (n=102) were non race-focused yet did not report race, while 2% (n=4) were non gender-focused and did not report gender. Forty-six percent of trials that reported the race/ethnicity of the sample reported only one or two racial/ethnic categories, and in 43% of these trials the total number of individuals reported in each race/ethnicity category did not equal the total reported sample size. Analysis of results by race/ethnicity was reported in only two trials, and by gender in only three trials. In diseases with known racial and ethnic disparities, many clinical trials do not report the race/ethnicity of the study participants, and almost none report analyses by race/ethnicity. Although federal initiatives mandate inclusion of minority groups in research, that inclusion has not translated to reporting of results that might guide therapeutic decisions.
Giselle Corbie-Smith; Diane Marie M St George; Sandra Moody-Ayers; David F Ransohoff
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.; Review    
Journal Detail:
Title:  Journal of clinical epidemiology     Volume:  56     ISSN:  0895-4356     ISO Abbreviation:  J Clin Epidemiol     Publication Date:  2003 May 
Date Detail:
Created Date:  2003-06-18     Completed Date:  2003-08-11     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8801383     Medline TA:  J Clin Epidemiol     Country:  England    
Other Details:
Languages:  eng     Pagination:  416-20     Citation Subset:  IM    
Department of Social Medicine, University of North Carolina at Chapel Hill, CB 7240, Chapel Hill, NC 27599, USA. <>
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MeSH Terms
Continental Population Groups*
Data Collection
Data Interpretation, Statistical
Ethnic Groups*
Health Resources*
Minority Groups
Randomized Controlled Trials as Topic*
United States
Grant Support

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