Recruiting Diverse Populations in Clinical Trials: How Do We Overcome Selection Bias?

Recruitment of diverse populations into clinical trials is very important not only because it enhances the potential generalizability of the results but also because it allows consideration of whether certain subgroups may respond differentially to a particular treatment. Despite our understanding of the strengths that diverse subject recruitment brings to research, clinical trials in this country typically fail to recruit populations that match the diversity of the US population, largely because of systematic barriers. The field of Alzheimer disease (AD) research is particularly guilty of underrecruiting underrepresented individuals, with only 10% of participants in AD Cooperative Study (ADCS) clinical trials and only 3.2% of participants in pharmaceutical trials being non-White.1 This is problematic given the high rates of dementia in general and of AD in particular in Black and Hispanic individuals.2 Further complicating the issue is the high rate of mixed (i.e., AD plus vascular/other etiologies) pathology in individuals clinically diagnosed with AD, with mixed pathology being noted more frequently in Black (vs White) patients.3 As in vivo diagnosis of AD-related neuropathology with imaging and blood-based biomarkers becomes increasingly possible, understanding these potential differences in pathology is crucial to contextualize study results.

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