USA – FDA Encourages Inclusion of Older Patients in Cancer Trials

The US Food and Drug Administration (FDA) is looking to encourage drugmakers to include more elderly patients in cancer clinical trials to ensure that the patient population in those studies better reflects the real-world patient population.

« Enrolling a broad representation of patients in clinical trials is an important tenet of clinical research as it facilitates a better understanding of the drug’s benefits and risks across the patient population likely to take the drug. However, because cancer incidence increases with age, and given the aging US population, it’s particularly important now more than ever to ensure that older adults are also enrolling in cancer clinical trials,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence.

Specifically, the guidance calls on sponsors to try to enroll patients ages 65 and older in clinical trials for cancer treatments, from early-stage studies to pivotal trials.

“Older adults, including those with frailty, should be enrolled in all phases of clinical trials, when they can be safely and ethically enrolled,” FDA writes, noting that sponsors should consider the age demographics of the target patient population early on…