Module232025

07/05/2025

What do we mean by “underserved groups”?

One research healthcare definition: groups that are less well represented in research than would be expected based on their population prevalence or healthcare needs Reasons: Geographical – difficult to reach Race, ethnicity, cultural, socio-economic 4 categories, but 13 possible groups Difficult to work with - age, cognition, multiple pathologies, linguistics, disabilities

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Geographic impediments to research participation Primarily arise from the distance between potential participants and research sites, exacerbated by 12- and 24-hr post-dose readings; visit frequency; transportation costs; time off work, with loss of earnings; Child or other dependent care. Options:

Transportation assistance - provide support to facilitate participation. Alert IRB/REC to level of support – does it amount to inducement? Alert Regulatory Authorities – FDA sometimes holds a narrow view Decentralised trial structure

Be careful – increased participant burden, esp. re technology; data quality issues; division of responsibilities and liabilities between the investigator and the treating physician; data privacy challenges; internet access

IMP transportation and storage Remember the IMP may be exposed to temperature and humidity levels beyond those for which it is qualified

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