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BiDil, subgroup analyses, and the limits of evidence-based medicine

January 8 2007

Venue: Seminar room 1.06, Old Surgeons' Hall, High School Yards

Organised by: Innogen

Seminar at Edinburgh University: Prof George Ellison, Department of Health Sciences, St George’s, University of London

The deliberate exclusion of non-`black' participants in a recent clinical trial goes against recent moves to make clinical trial populations more inclusive and more representative of the populations targeted by the therapies involved. Focussing on biological explanations for racial differences in morbidity and pharmacological responsivity reinforces the discredited notion that race is biologically-determined. However, to some extent these criticisms simply reflect pre-existing practices in evidence-based medicine and epidemiology: the participants enrolled in drug trials rarely represent the target population. There is a growing interest in improving the quality of subgroup analyses in clinical trials, not least because this would reduce the unnecessary costs and side-effects of using treatments in clinical and social subgroups where there is no evidence of effectiveness.,1349,en.t4.html