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Logo of bmjThis ArticleThe BMJ
BMJ. 2008 January 5; 336(7634): 46.
PMCID: PMC2174740

It’s time to reappraise recruitment of South Asians to clinical trials

Brian D Gammon, research nurse1 and Ashan Gunarathne, research registrar in cardiology2

Despite a policy of inclusiveness in health care, the United Kingdom has made little progress in improving overall health among marginalised groups.1 There is a pressing need for clinical studies among South Asian, black, and other ethnic minority groups to aid the development of targeted strategies to prevent cardiovascular disease. A 1991 study, for example, showed that South Asians—then 4% of the total UK population—bore a disproportionately high burden of mortality from coronary heart disease and stroke.2 Health issues associated with the ageing of Britain’s ethnic minority population mean that new policy initiatives are urgently needed. Despite this urgency, however, this group is very rarely the focus of clinical investigations to prevent the adverse consequences of this disease burden.

The reasons often given for South Asians’ lack of access to clinical trials include language difficulties, poorer access to health care, deprivation, alleged institutional discrimination, and a lack of cross cultural understanding and cultural competence.3 The South Asian population in the West Midlands, for example, is mainly clustered in inner city areas such as Sandwell and Walsall, where all indices of social deprivation are above the upper quintile in most electoral wards.4 5 Between 20% and 25% of people in these areas are black or South Asian, including Bangladeshi (1.2%), Indian (9.1%), and Pakistani (3%) people. Educational achievement is limited, with between 34% and 54% of people reporting no educational qualification.4 Pakistani and Bangladeshi people are among the lowest reporters of “fair to good health” and among the most likely to have long term illnesses.4

Of the trials listed in the national research register ( only 87 (less than 0.1%) involved South Asians, of which 32 were quantitative and 52 were qualitative, while three were evaluations of existing trials. Thirty nine of these 87 trials (45%) involved only South Asians. Six of the 87 (7%) were randomised controlled trials, and only one of these exclusively involved South Asians and looked at outcome reduction in cardiovascular disease. As randomised controlled trials are seen as the best way to obtain unbiased data, the paucity of trials involving this ethnic group inevitably prejudices the validity of their findings, limiting the usefulness of epidemiological and outcome data.

In our experience of engaging potential South Asian participants in trials (experience mirrored by others6), salient points emerge. Firstly, the arbitrary exclusion of potential participants according to outdated concepts of ethnicity may be exacerbated by researchers’ entrenched attitudes. Language differences, for example, need not be a problem, as long as funding is available for the provision of interpreters. Secondly, we have found it to be untrue that such participants fail to understand the research process: they will, as long as enough time and organisational support are available. Thirdly, many South Asian participants enter trials because they think that they will be better able to take part in treatment decisions or that they will gain access to a wider range of services. Fourthly, South Asian trial participants often seem to be passive in healthcare decision making, abrogating responsibility to other family members,7 or to profess a determinist outlook or religious fatalism or ascribe happenings to chance. A belief among South Asians that clinical trials are a form of experimentation may also affect their desire to participate in trials.

Furthermore, although South Asians are unlikely to ignore Western drugs in favour of traditional treatments, they are likely to turn to other remedies if they see Western medicine as failing to result in a cure (as with placebos). Thwarted expectations concerning the effect of drugs is one of the main reasons for people dropping out of trials after randomisation. Finally, sufficient thought should be given to protocol design, particularly to frequency of investigative procedures, education about side effects, and the time allotted for each visit, which should allow for the unhurried exchange of information.

The seeming reluctance of South Asians and members of other ethnic minority groups to participate in clinical trials, as evidenced by their low representation, is multifactorial and is part of a complex decision making process. It should not be assumed that reluctance is due to ethnicity, levels of deprivation, literacy, or cultural difference. Such assumptions mean that the development of specific, targeted intervention programmes will be considerably delayed.8

Although here we have discussed the issue of recruitment and retention of people from ethnic minorities in individual trials, a broader issue is the relatively small number of trials involving South Asians, particularly in cardiovascular research. More research is needed to discover how these issues are related. Barriers to a more inclusive programme of research must be overcome, and this requires inventiveness, flexibility, rigorous planning, and the proper estimation and provision of funds to enable the recruitment of marginalised group members such as South Asians. This will enable a much fuller understanding of the genetic and environmental variables in illness.

It should not be assumed that reluctance is due to ethnicity, levels of deprivation, literacy, or cultural difference


1. Gill PS, Kai J, Bhopal RS, Wild S. Health care needs assessment: black and minority ethnic groups.
2. Balarajan R. Ethnic differences in mortality from ischaemic heart disease and cerebrovascular disease in England and Wales. BMJ 1991;9:560-4.
3. Vydelingum V. Nurses’ experiences of caring for South Asian minority ethnic patients in a general hospital in England. Nurs Inq 2006;13:23-32. [PubMed]
4. National Statistics Online. UK Census 2004.
5. Lip GY, Barnett AH, Bradbury A, Cappuccio FP, Gill PS, Hughes E, et al. Ethnicity and cardiovascular disease prevention in the United Kingdom: a practical approach to management. J Hum Hypertens 2007;21:183-211. [PubMed]
6. Hussain-Gambles M, Leese B, Atkin K, Brown J, Mason S, Tovey P. Involving South Asian patients in clinical trials. Health Technol Assess 2004;8: 1-109.
7. Bham Z, Ross E. Traditional and western medicine: cultural beliefs and practices of South African Indian Muslims with regard to stroke. Ethn Dis 2005;15:548-54. [PubMed]
8. Burchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, et al. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med 2003;348:1170-5. [PubMed]

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