Race, ethnic group, and clinical research

BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7418.763 (Published 02 October 2003) Cite this as: BMJ 2003;327:763
  1. Saif S Rathore (saif.rathore@yale.edu), lecturer,
  2. Harlan M Krumholz, professor of medicine (cardiology)
  1. Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, 333 Cedar Street, PO Box 208088, New Haven, Connecticut, 06520–8088, USA

    Implications of incorporating race and ethnicity into trials go beyond ethical issues

    Since 1993 guidelines issued by the US National Institutes of Health (NIH) have mandated the proportionate representation of patients by race and ethnic group in clinical research funded by the NIH. No similar requirement exists in the United Kingdom, although concerns of low participation by minorities in randomised trials have led to calls for the adoption of a similar standard.1 It is likely that the role of race in clinical research will also inevitably be addressed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (http://www.ich.org/) as part of its efforts to standardise clinical research in the United States, Europe, and Japan. Although ensuring equal opportunities for participation in randomised trials for members of all racial groups is ethical, we believe that the explicit consideration of race during enrolment in a randomised trial, and clinical research broadly, raises serious concerns.

    A recent report describing the enrolment of South Asian patients in randomised controlled trials conducted at the University of Leeds extends previous work documenting the relatively low enrolment of racial and ethnic minorities in randomised trials in the United States.1 2 Although the findings of these studies merit further exploration, several …

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