Why ethnic minority groups are under-represented in clinical trials: A review of the literature

Health and Social Care in the Community

Volumn 12, Issue 5, 2004, Pages 382-388

  Hussain Gambles, Mahvash ^a   Atkin, Karl ^a   Leese, Brenda ^a  

^a UNIVERSITY OF LEEDS   (United Kingdom)

Author keywords

Clinical trials; Ethnic minority groups; Participation in medical research; South Asian people; Under representation

Indexed keywords

CLINICAL TRIAL; COMMUNICATION DISORDER; CONTROLLED CLINICAL TRIAL; CULTURAL FACTOR; HUMAN; HUMAN EXPERIMENT; METHODOLOGY; MINORITY GROUP; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; REVIEW;

COMMUNICATION BARRIERS; CULTURAL CHARACTERISTICS; HUMAN EXPERIMENTATION; HUMANS; MINORITY GROUPS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS; REPRODUCIBILITY OF RESULTS;

EID: 4444245706     PISSN: 09660410     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2524.2004.00507.x     Document Type: Review

References (38)

1. Altman D.G. (1996) Better reporting of randomised controlled trials: the consort statement. British Medical Journal 313, 570-571.
2. Bach P.B., Cramer L.D., Warren J.L. & Begg C.B. (1999) Racial differences in the treatment of early-stage lung cancer. New England Journal of Medicine 341, 1198-1205.
3. Bartlett C., Davey P., Dieppe P., Doyal L., Ebrahim S. & Egger M. (2003) Women, older persons and ethnic minorities: factors associated with their inclusion in randomised trials of statins 1990-2001. Heart 89, 327-328.
4. Brawley O.W. (1998) The study of untreated syphilis in the Negro male. International Journal of Radiation Oncology, Biology, Physics 40, 5-8.
5. Brawley O.W. & Freeman H.P. (1999) Race and outcomes: Is this the end of the beginning for minority health research? Journal of the National Cancer Institute 91, 1908-1909.
6. Britton A., McKee M., Black N., McPherson K., Sanderson C. & Bain C. (1999) Threats to applicability of randomised trials: exclusion and selective participation. Journal of Health Services Research Policy 4, 112-121.
7. Cassell E.J. (2000) The Principles of the Belmont Report Revisited. Hastings Centre Report. Briarcliff Manor, New York.
8. Cooper H. (2002) Investigating socio-economic explanations for gender and ethnic inequalities in health. Social Science and Medicine 54, 693-706.
9. Corbie-Smith G., Thomas S.B., Williams M.V. & Moody-Ayers S. (1999) Attitudes and beliefs of African Americans toward participation in medical research. Journal of General International Medicine 14, 537-546.
10. Davey-Smith G., Chaturvedi N., Harding S., Nazroo J. & Williams R. (2000) Ethnic inequalities in health: a review of UK epidemiological evidence. Critical Public Health 10, 376-407.
11. Davis S., Wright P.W., Schulman S.F., Hill L.D., Pinkham R.D. & Johnson L.P. (1985) Participants in prospective, randomised clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials. Cancer 56, 1710-1718.
12. Department of Health (2000) The NHS Plan: A Plan for Investment, a Plan for Reform. HMSO, London.
13. Dignam J.J. (2000) Differences in breast cancer prognosis among African-American and Caucasian women. Ca: A Cancer Journal for Clinicians 50, 50-64.
14. Gifford A.L., Cunningham W.E., Heslin K.C., Anderson R.M., Nakazono T., Lieu D.K. & Shapiro M.F. (2002) Participation in research and access to experimental treatments by HIV-infected patients. New England Journal of Medicine 346, 1373-1382.
15. Hall W.D. (1999) Representation of blacks, women, and the very elderly (aged > or = 80) in 28 major randomized clinical trials. Ethnicity and Disease 9, 333-340.
16. Heiat A., Gross C. & Krumholz H. (2002) Representation of the elderly, women, and minorities in heart failure clinical trials. Archives of International Medicine 162, 1682-1688.
17. Hodge F.S., Weinmann S. & Roubideaux Y. (2000) Recruitment of American Indians and Alaska Natives into clinical trials. Annals of Epidemiology 10 (Suppl.), S41-S48.
18. Hohmann A.A. & Parron D.L. (1996) How the new NIH Guidelines on Inclusion of Women and Minorities apply: efficacy trials, effectiveness trials, and validity. Journal of Consulting and Clinical Psychology 64, 851-855.
19. Hussain-Gambles M. (2003) Ethnic minority under-representation in clinical trials: Whose responsibility is it anyway? Journal of Health Organisation and Management 17, 138-145.
20. Jain C., Narayan N. & Narayan P. (1985) Attitudes of Asian patients in Birmingham to general practitioner services. Journal of the Royal College of General Practitioners 35, 416-418.
21. Johnson M. & Szczepura A. (2002) Trial and error. CRE: Connections Autumn, 1-5.
22. Karjalainen S. & Palva I. (1989) Do treatment protocols improve end results? A study of survival of patients with multiple myeloma in Finland. British Medical Journal 299, 1069-1072.
23. Khan K.S., Riet G.T., Glanville J., Sowdon A.J. & Kleijnen J. (2001) Undertaking Systematic Reviews of Research on Effectiveness - CRD's Guidance for those Carrying out or Commissioning Reviews. University of York, York.
24. Killien M., Bigby J.A., Champion V., et al. (2000) Involving minority and underrepresented women in clinical trials: the National Centers of Excellence in Women's Health. Journal of Women's Health and Gender-Based Medicine 9, 1061-1070.
25. King T.E. & Brunetta P. (1999) Racial disparity in rates of surgery for lung cancer. New England Journal of Medicine 341, 1231-1233.
26. Krecic-Shepard M.E., Park K., Barnas C., Slimko J., Kerwin D.R. & Schwartz J.B. (2000) Race and sex influence clearance of nifedipine: results of a population study. Clinical Pharmacology and Therapeutics 68, 130-142.
27. Lee M.M., Chamberlain R.M., Catchatourian R., Hiang J., Kopnick M., Ray P. & Vijayakumar S. (1999) Social factors affecting interest in participating in a prostate cancer chemoprevention trial. Journal of Cancer Education 14, 88-92.
28. Magee M.H., Blum R.A., Lates C.D. & Jusko W.J. (2001) Prednisolone parmacokinetics and pharmacodynamics in relation to sex and race. Journal of Clinical Pharmacology 41, 1180-1194.
29. Mason S.A., Hussain-Gambles M., Leese B., Atkin K. & Brown J. (2003) Representation of South Asian people in randomised clinical trials: analysis of trials' data. British Medical Journal 326, 1244-1245.
30. McNagny S.E. & Parker R.M. (1992) High prevalence of recent cocaine use and the unreliability of patient self-report in an inner-city walk-in clinic. Journal of the American Medical Association 267, 1106-1108.
31. Meinert C.L. (1999) Redesign of trials under different enrolement mixes. Statistics in Medicine 18, 241-251.
32. National Institutes of Health (1994) NIH guidelines on the inclusion of women and minorities as subjects in clinical research. (Document no. 94-5435.) Federal Regulations 59, 14 508.
33. Ross S., Grant A., Counsell C., Gillespie W., Russell I. & Prescott R. (1999) Barriers to participation in randomised controlled trials: a systematic review. Journal of Clinical Epidemiology 52, 1143-1156.
34. Ryn van M. & Burke J. (2000) The effect of patient race and socio-economic status on physicians' perceptions of patients. Social Science and Medicine 50, 813-828.
35. Stallings F.L., Ford M.E., Simpson N.K., et al. (2000) Black participation in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Controlled Clinical Trials 21 (Suppl.), 379S-389S.
36. Stone V.E., Mauch M.Y. & Steger K.A. (1998) Provider attitudes regarding participation of women and persons of color in AIDS clinical trials. Journal of Acquired Immune Deficiency Syndromes 19, 245-253.
37. Swanson G.M. & Ward A.J. (1995) Recruiting minorities into clinical trials: toward a participant-friendly system. Journal of the National Cancer Institute 87, 1747-1759.
38. Thompson E.E., Neighbors H.W., Munday C. & Jackson J.S. (1996) Recruitment and retention of African American patients for clinical research: an exploration of response rates in an urban psychiatric hospital. Journal of Consulting and Clinical Psychology 64, 861-867.