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

Older people (aged 65 years +) are under-represented in clinical research across many disease areas. Such exclusions limit the generalisability of trial results and can lead to a gap in critical knowledge regarding the efficacy and safety of interventions in older age groups. International bodies and regulators have addressed this issue to varying degrees. The USA's Food and Drug Administration (FDA) has produced regular non-binding guidance about the inclusion of older trial participants, while the National Institutes of Health's (NIH) binding regulations mean that those seeking research funding must include participants of all ages unless there are scientific or ethical reasons to exclude them. European regulations governing clinical trials of new medications require that participants represent the population groups that are likely to use the product being tested, while Britain highlights the need to improve trial participation of under-served groups, which include older people. Australian clinical trial guidelines point to the potential problem of excluding some groups from research but do not specifically address older participants. While current international approaches may provide some improvements in trial representation, additional strategies are required to promote clinical research that better reflects populations seen in clinical practice. Australia could benefit from clinical trial guidance that highlights the specific issue of the under-representation of older participants and outlines strategies to facilitate greater inclusion. This article provides an overview and critique of the current approaches to the inclusion of older people in clinical research and highlights policy gaps and limitations of current strategies.