The causes and effects of socio-demographic exclusions from clinical trials

Abstract

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The Birmingham Rehabilitation Uptake Maximisation Study (BRUM). Home-based compared with hospital-based cardiac rehabilitation in a multi-ethnic population: cost-effectiveness and patient adherence

“…147,148 To ensure the generalisability of the results of this study to the UK population, it is important to have a study population that represents that of the communities in which the rehabilitation would be provided. 153,154 Given concerns about the lower uptake of CR in people from ethnic minority groups, we wanted to explore whether the provision of a home-based programme might improve uptake and adherence in this group. There have been concerns about the underrepresentation of people from ethnic minority groups in clinical trials 153,155 and trials of cardiac patients in particular, 156 but few trials of CR have even reported the ethnicity of their participants.…”

“…153,154 Given concerns about the lower uptake of CR in people from ethnic minority groups, we wanted to explore whether the provision of a home-based programme might improve uptake and adherence in this group. There have been concerns about the underrepresentation of people from ethnic minority groups in clinical trials 153,155 and trials of cardiac patients in particular, 156 but few trials of CR have even reported the ethnicity of their participants. Exclusion of ethnic minorities from clinical trials undermines the UK Government's NHS plan for tackling inequalities and its core principle of providing culturally appropriate and accessible care for different groups and individuals.…”

Participación de las mujeres en los ensayos clínicos según los informes de la Agencia Española de Medicamentos y Productos Sanitarios: 2007

“…En este tema se encuentran enfrentadas distintas opiniones, no existiendo una valoración unánime ni en cuanto en la necesidad de evitarlo ni en sus consecuencias [2][3][4][5][6][7] .…”

‘Randomisation bias’ in the medical literature: a review

“…Bartlett et al, 2005, andBornhöft et al, 2006) clearly highlighting the tension between features that safeguard internal validity (such as the randomisation itself, placebo and blinding) but at the same time worsen external validity or indeed generate or exacerbate what we call randomisation bias.…”

“…To this regard, a number of authors (e.g. Britton et al, 1998, Bartlett et al, 2005, and Van Spall et al, 2007 have advocated as the immediate priority the improvement of the quality of reporting, as information on eligibility criteria and participation is often simply lacking even for RCTs published in major medical journals.…”