Researchers at Leeds University investigated the ethnicity profile of six clinical trials recently conducted by the Northern and Yorkshire Clinical Trials and Research Unit. All were large, randomised controlled trials with large numbers of participants and centres.
South Asian (Indian, Pakistani, and Bangladeshi) people comprised between 0% and 1.7% of total participants in the six trials. This under-representation might be due to investigator bias, inappropriate strategies for recruitment, or cost issues – for example for translators or translations of information sheets, explain the authors.
Such inequality has important ethical and scientific ramifications because genetic predisposition, dietary intake, and exposure to environmental and occupational hazards lead to ethnic differences in susceptibility of diseases, they write. Furthermore, patients' response to drugs, and the side effects, can vary between different ethnic groups.
Increased awareness and monitoring of recruitment and retention of ethnic minority groups in clinical trials are needed, and analysis of data by ethnicity of subjects should be done consistently, add the authors.
More rigorous review by ethics committees and education of ethnic minority groups may contribute to attaining proportional representation of ethnic minorities in trials, they conclude.