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Elderly Patients Excluded from Clinical Trials

Tawfic Nessim Abu-Zahra, BSc, MSc

Elderly people (i.e. those over 65 years of age) tend to be excluded from clinical research trials in areas such as cancer and heart disease.1-4 Physicians wishing to make evidence-based treatment decisions for elderly patients may have to extrapolate clinical data from studies that have been conducted in a younger population. However, given that there are age-related changes that occur even in healthy elderly people, any such extrapolation may not be scientifically sound.1-3 Changes in physiological parameters that occur with increasing age, such as decreases in renal and cardiovascular function, blood flow and hepatic volume, make the disposition of drugs more variable in the elderly and predispose them to drug toxicities and adverse drug reactions.3 The result is that geriatric patients may not receive the newest therapies or may receive a treatment whose efficacy and safety in the elderly is not known.1-3

In a study published in the New England Journal of Medicine, Hutchins and colleagues5 determined the enrollment rate of cancer patients aged 65 years or older in clinical trials, and compared this with the corresponding rate of elderly cancer patients in the general population. Overall, the authors reported that the elderly were significantly underrepresented in all cancer trials and in 14 of the 15 types of cancer that were individually investigated.