Inclusion of Older Adults in Early-Phase Cancer Clinical Trials: Safety, Efficacy and a Way Forward

Early-phase clinical trials (EPCTs) are critical for evaluating the safety, tolerability, efficacy and pharmacokinetics of novel oncology therapies. However, older adults are underrepresented in all phases of oncology clinical trials, including early-phase trials, creating a significant gap in evidence-based cancer management in this population, which translates into clinical practice. This is despite cancer incidence increasing with age, and a substantial proportion of cancer diagnoses occurring in individuals aged ≥ 65 years. Ageing is associated with physiological, physical and psychosocial changes which could underlie the hesitancy to include older adults in early-phase clinical trials, due to concerns of excessively compromising their safety and quality of life. However, the landscape of EPCTs has changed with higher safety and efficacy data. This review explores the current landscape of older adults in early-phase clinical trials, including the participation rate, the outcomes, and the multifaceted challenges contributing to the underrepresentation of older adults, and examines the potential strategies to enhance the inclusivity of older adults for treating older adults with cancer.