From geriatric assessment to artificial intelligence, an ESMO/SIOG paper highlights effective strategies to improve the representation of older patients in clinical trials
The underrepresentation of older people in cancer research has become an increasingly urgent issue in ensuring high-quality care to all patients. In 2020, 64% of new cancer cases worldwide occurred in individuals aged 60 or above, and cancer incidence among the older population is expected to reach 20.7 million new cases by 2040 (J Natl Cancer Cent. 2024 May 9;4(3):223–232). Despite the global cancer patient population aging, most of what we know about the risks and benefits of cancer therapeutics is based on clinical trials conducted in younger, fitter and healthier patients, and treatment strategies do not adequately address the diversity, priorities and expectations of older patients (CA Cancer J Clin. 2020 Oct 1;71(1):78–92).
“While clinical trials typically focus on traditional outcomes such as treatment efficacy and survival, older adults often value the quality of time as much as the quantity of time,” explains Dr Anna Mislang from the Department of Medical Oncology, Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia. “Priorities such as quality of life and maintaining functional independence are frequently overlooked or underreported, but it is vital to define research endpoints that reflect the specific needs and preferences of this patient population.” Mislang is part of the ESMO/SIOG Cancer in the Elderly Working Group which has identified strategies to improve clinical trial designs and endpoints by better integrating older patients’ needs, now available on ESMO Open (Articles in Press, February 22, 2026).
Adapting trial design to older patients
When designing clinical trials specifically for older cancer patients, several critical factors need to be considered, including sensory limitations or cognitive impairments who may result in additional time constraints for research teams. “Enrolling an older adult often requires more comprehensive assessments, including evaluations of functional status and patient priorities, which can be difficult to accommodate when time and resources are limited,” adds Dr Capucine Baldini, from the Drug Development Department (DITEP) at the Gustave Roussy, Villejuif, France, who authored the paper with Mislang. “Also, from the clinician’s perspective, age-related bias can play a significant role: physicians may be concerned about potential toxicities of new treatments and hesitant to add additional burden to older patients.”
Despite these and other barriers, incorporating Geriatric Assessment and Management (GAM) into care pathways, as well as using lower or stepwise dose interventions or stratification based on Geriatric Assessment (GA), which may improve treatment tolerance, appear to be effective approaches to enhance clinical trial design and increase older patients’ inclusion and participation. “Shifting the focus toward quality of life and functional independence transforms treatment decisions from disease-centred to patient-centred. While integrating these endpoints is complex, it can be achieved through GA-guided adaitive trial designs,” continues Mislang. “Without systemic shifts in how trials are designed and regulated, clinician and patient-related barriers will remain secondary to a framework that inherently excludes the older participants.”
Read full article: https://dailyreporter.esmo.org/news/how-to-close-the-age-gap-in-clinical-cancer-research
