The US Food and Drug Administration is calling on drug companies to include more older adults in clinical trials for cancer drugs, Science reports.
It adds that the agency released a new guidance urging companies to enroll people over the age of 65 and especially people over the age of 75 in clinical trials, including early-stage trials. City of Hope's William Dale tells Science that people 65 years old and older make up about half of cancer patients, but only about a quarter of trial participants. This means, he adds, that drugs are largely approved on the basis of studies in younger individuals but then are applied to mostly older individuals.
In its guidance, FDA says clinical trial populations should reflect the population that would receive the treatment, if approved. In particular, it suggests targeting recruitment strategies to older adults as well as reporting more discrete age groups and studying drug interactions and co-morbidities among older adults. "Enrolling an adequate representation of the range of patients in a clinical trial that may be exposed to a drug after approval can maximize the generalizability of the trial results," FDA says.