Advancing the methodology of clinical trials for aging populations: A call to innovation, inclusion, and global relevance

The ongoing global trend of population aging urges the design and implementation of clinical trials that are not only scientifically rigorous but also inclusive and tailored to the unique needs of older adults. Indeed, despite representing the largest and fastest-growing segment of healthcare service users, older individuals remain underrepresented in clinical trials. It is especially concerning that clinical trials systematically exclude those who are representative of the typical patient populations that will eventually use the tested interventions [1]. Their omission is often justified due to chronological age, multimorbidity, frailty, cognitive impairment, disability, or logistical concerns [2,3]. However, the gap between trial populations and real-world patients compromises the external validity and generalizability of clinical evidence, while perpetuating health inequities and hindering person-centered care. As a matter of fact, older adults are often treated based on clinical guidelines and treatment protocols that are extrapolated from research conducted in younger, healthier, and more homogeneous populations, potentially leading to suboptimal (or inappropriate) care and outcomes [4].