Frailty in clinical drug trials: application to recruitment, subgroup
analyses and outcomes
Abstract
Clinical drug trials have traditionally focused on younger, healthier
participants with less comorbidities and excluded frail older adults due
to concerns regarding their ability to tolerate and respond to
treatments. However, with population ageing, drug trials are
increasingly turning their attention to older, frailer people. The aim
of this review is to provide an overview of how frailty was assessed in
published studies related to clinical pharmacological trials, and on the
interaction of frailty on the safety and efficacy of the treatments. We
searched MEDLINE, EMBASE and Cochrane for studies published in English
that focused on clinical drug trials in older people. The review showed
that frailty has been increasingly and successfully applied into
clinical drug trials, especially trials in patients with cardiovascular
disease and cancer. In most of the studies in the review, frailty was
assessed retrospectively. How frailty was treated in statistical
regression models was not consistent among the studies. Frailty was
treated as an ordinal variable (with different levels of frailty) or
binary variable (frail/non-frail) using cut-offs in some studies, and as
a continuous in some other studies. There was heterogeneity in the
effect of frailty, depending on the disease and treatment type. The
results of this review suggest that frailty should not be assumed to
always attenuate treatment effects, and routine measurement of frailty
in participants in clinical drug trials would improve our knowledge of
the effect of treatment in the frail and identify those who have more or
least to gain from treatment.