Older people make up the majority of cancer patients, but only represent about one-quarter of cancer clinical trial participants. New FDA recommendations aim to change that.
urging companies to boost representation of people over 65 years old, and especially over 75. The recommendations span studies of experimental cancer treatments, including in the earliest phases, where the skewing to younger people appears more pronounced. Although the agency’s guidance isn’t binding, oncologists hailed it as an important step toward badly needed change in cancer clinical trials.
Excluding older adults can lead to unpleasant surprises after a cancer drug is approved and prescribed to a very different group of patients—those who have an assortment of health problems, take multiple medications, are frail, or simply have different biology because of their age. For example, older individuals can struggle with blood pressure regulation, in part because of declining kidney function, and certain cancer drugs can cause their blood pressure to spike, Dale says.
The new FDA guidance, which was released in draft form in 2020 before being revised to yesterday’s final version, urges companies to enroll older adults in even early cancer studies, in which safety is initially assessed. Those early phase studies could help refine drug doses in older patients to guide the much larger later trials. FDA is also pressing companies to get creative.