Exclusion of elderly patients in clinical trials

There is an interesting editorial in this month’s Transplantation discussing the exclusion of elderly patients from clinical trials. Such practice clearly has an impact on the generalisability of the results of trials to an increasingly ageing transplant population (the proportion of US kidney transplant recipients aged 65 or over doubled from 7% to 16% between 1999 and 2008). In trials of immunosuppression, it is equally important to document differences in absorption and metabolism in elderly patients that may affect dosing in this important group.

The article highlights current FDA guidance on enrolment of elderly patients to clinical trials, and is well worth a read.