Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: Have we made progress?

Journal of Women's Health

Volumn 20, Issue 3, 2011, Pages 315-320

  Geller, Stacie E ^a,c   Koch, Abby ^a   Pellettieri, Beth ^a   Carnes, Molly ^b  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b UNIVERSITY OF WISCONSIN MADISON   (United States)

^c UNIVERSITY OF ILLINOIS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); COMPLIANCE (PHYSICAL); CULTURAL ANTHROPOLOGY; ETHNICITY; HUMAN; MEDICAL LITERATURE; MEDLINE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RACE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEX;

ETHNIC GROUPS; EVIDENCE-BASED MEDICINE; FEMALE; GUIDELINE ADHERENCE; HUMANS; MALE; MINORITY GROUPS; NATIONAL INSTITUTES OF HEALTH (U.S.); PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RESEARCH SUPPORT AS TOPIC; UNITED STATES; WOMEN'S HEALTH;

EID: 79952749048     PISSN: 15409996     EISSN: None     Source Type: Journal    
DOI: 10.1089/jwh.2010.2469     Document Type: Article

References (22)

1. National Institutes of Health. NIH guidelines on the inclu-sion of women and minorities as subjects in clinical research. Fed Regist 1994;59:14508-14513.
2. Office of Extramural Research NIH. NIH policy and guide-lines on the inclusion of women and minorities as subjects in clinical research\Amended, October 2001. Department of Health and Human Services, National Institutes of Health. Available at grants.nih.gov/grants/funding/women-min/guidelines-amended- 10-2001.htm Accessed November 6, 2009.
3. NIH/ORWH. Office of Research on Women's Health out-reach publications. Available at orwh.od.nih.gov/inclusion/incloutreach.html Accessed September 9, 2010.
4. NIH Tracking/Inclusion Committee. Tracking of human subjects research as reported in fiscal year 2006 and fiscal year 2007. Department of Health and Human Services, Na-tional Institutes of Health 2008.
5. Geller SE, Adams MG, Carnes M. Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials. J Womens Health 2006;15:1123-1131. (Pubitemid 46157484)
6. Vidaver RM, Lafleur B, Tong C, Bradshaw R, Marts SA. 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. (Pubitemid 30426926)
7. Corbie-Smith G, St George DM, Moody-Ayers S, Ransohoff DF. Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities. J Clin Epidemiol. 2003;56: 416-420. (Pubitemid 36694093)
8. Ramasubbu K, Gurm H, Litaker D. Gender bias in clinical trials: Do double standards still apply? J Womens Health Gend Based Med 2001;10:757-764. (Pubitemid 33062085)
9. Revisions to the standards for the classification of federal data on race and ethnicity. Fed Regist 1997;62:58781-58790.
10. Kim ES, Carrigan TP, Menon V. Enrollment of women in National Heart, Lung, and Blood Institute-funded cardio-vascular randomized controlled trials fails to meet current federal mandates for inclusion. J Am Coll Cardiol 2008;52: 672-673.
11. Blauwet LA, Hayes SN, McManus D, Redberg RF, Walsh MN. Low rate of sex-specific result reporting in cardiovas-cular trials. Mayo Clin Proc 2007;82:166-170. (Pubitemid 46198474)
12. Uhl K, Parekh A, Kweder S. Females in clinical studies: Where are we going? Clin Pharmacol Ther 2007;81:600-602. (Pubitemid 46452313)
13. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine\Reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357:2189-2194.
14. Epstein S. Inclusion: The politics of difference in medical research. Chicago: The University of Chicago Press, 2007.
15. Nguyen LL, Hevelone N, Rogers SO, et al. Disparity in outcomes of surgical revascularization for limb salvage: Race and gender are synergistic determinants of vein graft failure and limb loss. Circulation 2009;119:123-130.
16. Department of Health and Human Services, National In-stitutes of Health Institutional Clinical and Translational Science Award, RFA-RM-07-002. 2006.
17. Shalowitz MU, Isacco A, Barquin N, et al. Community-based participatory research: A review of the literature with strategies for community engagement. J Dev Behav Pediatr 2009;30:350-361.
18. Dresser R Wanted: Single, white male for medical research Hastings Cent Rep 1992;22:24-29.
19. Mendelsohn KD, Nieman LZ, Isaacs K, Lee S, Levison SP. Sex and gender bias in anatomy and physical diagnosis text illustrations. JAMA 1994;272:1267-1270. (Pubitemid 24321052)
20. Carnes M, Morrissey C, Geller SE. Women's health and women's leadership in academic medicine: Hitting the same glass ceiling? J Womens Health 2008;17:1453-1462.
21. Schulz KF, Altman DG, Moher D. CONSORT 2010 state-ment: Updated guidelines for reporting parallel group ran-domized trials. Ann Intern Med 2010;152:726-732.
22. Kim A, Tingen C, Woodruff T. Sex bias in trials and treat-ment must end. Nature 2010;465:688-689.