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Assess international regulatory frameworks addressing the under-representation of older adults in clinical research and identify critical policy gaps.

September 19, 2023Australasian Journal on AgeingOpen Access

International responses addressing the under‐representation of older people in clinical research

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Assess international regulatory frameworks addressing the under-representation of older adults in clinical research and identify critical policy gaps.
Comparative analysis of regulatory frameworks and clinical trial guidelines governing older participant inclusion across the United States, Europe, Britain, and Australia.
Evaluation of enforcement mechanisms, contrasting binding research funding mandates with non-binding recommendations.
The United States enforces binding NIH lifespan inclusion policies alongside non-binding FDA guidance, while European regulations require participant demographics to reflect intended drug consumers.
Britain prioritizes under-served cohorts including older demographics, whereas Australian trial guidelines lack targeted strategies to address older participant under-representation.
Current international regulatory models remain inconsistent, perpetuating evidence gaps concerning drug efficacy and safety profiles in older clinical populations.

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Implication

Policy review reveals variable regulatory requirements for clinical trial diversity in older populations, highlighting the need for enforceable inclusion standards.

Cite This Study

Markham et al. (2023) studied this question.

synapsesocial.com/papers/6aaa198ebf5b892176fca1cd https://doi.org/10.1111/ajag.13234

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Implication

Policy review reveals variable regulatory requirements for clinical trial diversity in older populations, highlighting the need for enforceable inclusion standards.

International responses addressing the under‐representation of older people in clinical research

Key Points

Discussion

Implication

Cite This Study

International responses addressing the under‐representation of older people in clinical research

Key Points

Discussion

Implication

Cite This Study

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