Abstract
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.
Keywords
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References
U.S. Department of Health and Human Services. Eliminating racial and ethnic disparities in health: overview. Available from: via the Internet (http://raceandhealth.hhs.gov/sidebars/sbinitOver.htm). Accessed April 1, 2003.
National Institute of Health Revitalization Act of 1993.
- NIH Guidelines on the Inclusion of Women and Minorities as subjects in clinical research.Fed Regist. 1994; 59: 14508-14513
- Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993—the perspective of NIH clinical trialists.Control Clin Trials. 1995; 16 (discussion 286–9, 293–309): 277-285
- How the new NIH Guidelines on Inclusion of Women and Minorities apply: efficacy trials, effectiveness trials, and validity.J Consult Clin Psychol. 1996; 64: 851-855
National Institute of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research-amended October, 2001. Available from: http://grants2.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. Accessed October 18,2001.
- A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group.JAMA. 1994; 272: 1926-1931
- Improving the quality of reporting of randomized controlled trials. The CONSORT statement.JAMA. 1996; 276: 637-639
- SAS/STAT user's guide. Version 6. 4th ed. SAS Institute Inc, Cary, NC1990
- Selection and description of cancer clinical trials participants—science or happenstance?.Cancer. 2002; 95: 950-959
- Representation of elderly persons and women in published randomized trials of acute coronary syndromes.JAMA. 2001; 286: 708-713
- Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute.N Engl J Med. 2000; 343: 475-480
- Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials.J Natl Cancer Inst. 1996; 88: 812-816
- Underrepresentation of patients 65 years of age or older in cancer-treatment trials.N Engl J Med. 1999; 341: 2061-2067
- Participation in research and access to experimental treatments by HIV-infected patients.N Engl J Med. 2002; 346: 1373-1382
- Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995–1999.J Natl Med Assoc. 2001; 93: 18S-24S
- Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation.J Clin Epidemiol. 1996; 49: 395-400
- Within trial variation—a false trail?.J Clin Epidemiol. 1998; 51: 301-303
- Incommunicable knowledge? Interpreting and applying the results of clinical trials and meta-analyses.J Clin Epidemiol. 1998; 51: 289-295
- Clinical versus statistical considerations in the design and analysis of clinical research.J Clin Epidemiol. 1998; 51: 305-307
- The problem of cogent subgroups: a clinicostatistical tragedy.J Clin Epidemiol. 1998; 51: 297-299
- Racial profiling in medical research.N Engl J Med. 2001; 344: 1392-1393
- Women subjects in NIH-funded clinical research literature: lack of progress in both representation and analysis by sex.J Womens Health Gend Based Med. 2000; 9: 495-504
- US health journal Editors' opinions and policies on research in race, ethnicity, and health.J Natl Med Assoc. 1998; 90: 401-408
- Publication bias in clinical research.Lancet. 1991; 337: 867-872
Article info
Publication history
Accepted:
January 28,
2003
Received in revised form:
January 21,
2003
Received:
August 30,
2002
Identification
Copyright
© 2003 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
