Health technology assessment : HTA
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Health Technol Assess · Oct 2005
ReviewThe causes and effects of socio-demographic exclusions from clinical trials.
To investigate the exclusion from trials of women, older people and minority ethnic groups, focusing on two drug exemplars, statins and non-steroidal anti-inflammatory drugs (NSAIDs). ⋯ The issue of exclusion from trials of women, older people and ethnic minorities has been relatively neglected in the UK research community, and there is confusion about diversity issues. Under-representation occurs, but in drug trials at least this may not always affect the external validity of relative effect estimates. However, measures of absolute effectiveness, absolute harm and cost-effectiveness are associated with underlying risk levels in different socio-demographic groups. Under-representation will therefore bias absolute effect estimates. The following areas are suggested for future research: multi-disciplinary assessment of realistic options for trialists to address the issue of exclusions; clarification of the use of ethnic categories in health research and of the implications of the different dimensions of ageing and sex/gender; identification of barriers and facilitators to the involvement of different population groups in research, further investigation of the susceptibility of older men to NSAID adverse events, and the development of a 'register of registries and databases' and exploration of how linked health information systems in the UK could be improved.